New Bioelectronic Devices May Aid in Monitoring, Treating Parkinson’s


Special bioelectronic devices that can be placed inside a person to diagnose, monitor, and treat neurological disorders, including Parkinson’s disease and epilepsy, may have taken a major step forward with the design of soft and flexible devices that are also biocompatible.

Dion Khodagholy, PhD, assistant professor of electrical engineering at Columbia University, recently published two studies on such new devices that may open the door to new therapies.

“Instead of having large implants encapsulated in thick metal boxes to protect the body and electronics from each other, such as those used in pacemakers, and cochlear and brain implants, we could do so much more if our devices were smaller, flexible, and inherently compatible with our body environment,” Khodagholy, who leads the Translational NeuroElectronics Lab at Columbia Engineering, said in a university news story.

“Over the past several years, my group has been working to use unique properties of materials to develop novel electronic devices that allow efficient interaction with biological substrates — specifically neural networks and the brain,” she added.

In both papers, Khodagholy worked alongside Jennifer N. Gelinas, MD, PhD, an assistant professor of neurology at the Institute for Genomic Medicine at Columbia University Irving Medical Center.

In the first study, “Enhancement-mode ion-based transistor as a comprehensive interface and real-time processing unit for in vivo electrophysiology,” published in the journal Nature Materials, they described the creation of organic transistors designed to record the electrical activity of neurons, and to perform real-time calculations that help in identifying and monitoring neurological disorders.

Transistors are devices that generate, amplify, and control the transmission of electrical signals.

Conventional transistors are made of silicon, and have to be encapsulated in a metal or plastic case when placed inside the body to protect from water and ions (electrically charged atoms). These new transistors are made up of organic materials that allow them to pick up and interact with the ion-driven signals that cells use to communicate.

An initial drawback, however, was that these organic transistors lacked electrical power to record and process brain signals.

To overcome this, Khodagholy and his team created a new version of these transistors with mobile ions embedded into their channels.

The team’s new ion-driven transistors, which they named e-IGTs, were able to capture a wide range of signals, including electrical impulses from neurons.

Investigators then used them as a basis to build soft, biocompatible devices that could be remain inside a person’s body for long periods of time, capturing and recording electrical signals associated with epilepsy.

“We’re excited about these findings,” Gelinas said. “We’ve shown that e-IGTs offer a safe, reliable, and high-performance building block for chronically implanted bioelectronics, and I am optimistic that these devices will enable us to safely expand how we use bioelectronic devices to address neurologic disease.”

In the second study, “Mixed-conducting particulate composites for soft electronics,” published in the journal Science Advances, the team described the creation of a soft mixed-conducting particulate material (MCP) that enabled them to build fully biocompatible devices to record muscle and brain electrical activity during deep brain stimulation (DBS) in patients.

DBS is a surgical procedure that involves implanting a device to stimulate specific regions of the brain with electrical signals generated by a battery. The procedure is approved to treat several neurological conditions, including Parkinson’s, epilepsy, and obsessive-compulsive disorder (OCD).

Using living cells that communicate through electrical signals as an inspiration, the team created MCP, a special material that is able to perform several electronic functions by varying the size and density of its electron-conductive particles.

Because it is fully biocompatible, MCP can also bridge the gap between rigid electronic components and soft body tissues, allowing for more effective electronic bonding.

“This innovation opens the door to a fundamentally different approach to electronic device design, mimicking biological networks and creating multifunctional circuits from purely biodegradable and biocompatible components,” Khodagholy said.

E-IGTs and MCP may support the development of a range of biocompatible and bioelectronic devices for therapeutic applications. Both use inexpensive components and can easily be manufactured at a large scale, their developers said.

Khodagholy and Gelinas are now working to create fully functional devices based on these components, which can be used to record and control brain’s electrical activity in people with Parkinson’s, epilepsy, and other neurological diseases.

“Our ultimate goal is to create accessible bioelectronic devices that can improve peoples’ quality of life, and with these new materials and components, it feels like we have stepped closer to that,” Khodagholy said.

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Invertigo’s ‘Dancing Through Parkinson’s’ Moves Online During COVID-19 Pandemic


Throughout the global COVID-19 pandemic, the Invertigo Dance Theatre will conduct its weekly Dancing Through Parkinson’s (DTP) classes online.

Starting May 7, the Los Angeles, California-based company will offer free streaming classes live on Zoom each Thursday at 1:30 p.m. PT. The sessions will be recorded and available for later viewing. There also are online video classes available at

The DTP dance curriculum is designed to meet the needs of those with Parkinson’s or other neurological conditions, regardless of disease stage. The classes are taught by professional dancers trained in methods to specifically benefit Parkinson’s patients, and designed to promote physical stability, mental clarity, and creativity.

Participants may move at their own pace, and no dance experience is required. Movement may be done while seated, standing, or with the help of a walker.

“Our dance classes invite people with Parkinson’s and those with limited mobility into movement as a source of joy, strength, and discovery,” K. Bradford, Invertigo’s community engagement manager, said in a press release.

“Our participants tell us they find healing and a sense of belonging in the DTP community, and that the classes foster a greater wellbeing in what can be an isolating time. Our teachers’ hearts are fully engaged in the classes, and we’re so glad that our online studio can transmit care, art, and community while people shelter — and dance — at home,” she said.

The DTP online classes are modeled after its in-person studio classes, and are taught by Kelsey Ang, Linda Berghoff, Heidi Buehler, Jess Evans, Haylee Nichele, and Rachel Whiting.

Longtime DTP participant Jeanie McNamara said this about her first online class: “This is phenomenal. What a wonderful collaborative class, and what a gift to all of us who are working hard to continue moving without going anywhere. Thank you for all that you are doing so that we can continue to battle [Parkinson’s] while trapped at home.”

Each session starts with a seated warm-up exercise that incorporates breath work, upper body stretches, and joint mobility. While remaining seated, participants perform choreography, tap work and other routines. Then, while seated or standing, dancers engage in a modified ballet barre exercise. At the end, instead of the traditional in-person “circle of gratitude,” each participant is asked to place a hand over his or her heart.

“We believe everyone is a dancer. We just ask you to give us a chance to prove that to you,” said  Berghoff, a DTP instructor and Invertigo board member. “…We still need to dance. Parkinson’s doesn’t stop just because the world does.”

A lifetime dancer, Berghoff was diagnosed with Parkinson’s in 2006 and thought she’d never dance again. A “Dance for PD” class in New York changed that perspective, and she began collaborating with Invertigo to create a dance class for Parkinson’s patients on the West Coast.

Established in 2011, DTP is an ongoing Invertigo Dance Theatre community program. It traditionally offers Parkinson’s patients free weekly dance classes in studios throughout southern California.

Because Parkinson’s patients usually experience motor and cognitive impairment, as well as mood changes and social isolation, dance may positively affect their quality of life, according to the International Parkinson and Movement Disorder Society.

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Access to Knowledge, Treatment of Parkinson’s Still Lacking in Many Regions


Some parts of the world are only beginning to understand Parkinson’s disease. Often, the general public misidentifies symptoms of the disease, complicating an early diagnosis.

While researchers are still attempting to understand the causes of Parkinson’s disease, the symptomatology of it has improved in accuracy since James Parkinson originally identified it in the early 19th century.

The following two studies evaluate the relationship between Parkinson’s disease treatment and misinformation or a lack of information about the disease. Does catching the disease at an early stage help us manage it better? It is possible that improving our understanding and access to knowledge about the disease can lead to better treatment.

Parkinson’s disease in Uganda

Finding effective treatment is complicated by a lack of knowledge surrounding a disease. If you are unable to identify a disease’s symptoms, treatment becomes less efficient.

A research article published in 2015 by Mark Kaddumukasa and others suggests that misunderstanding a disease like Parkinson’s can delay early treatment: “Despite advancements in treatment, diagnosis, and care of Parkinson’s disease patients’, lack of adequate knowledge and associated beliefs and attitudes among the community dwellers might have an important role in limiting access to proper treatment and care,” the study’s authors wrote.

So, even though our ability to treat Parkinson’s disease is advancing, misinformation and attitudes surrounding the disease might negatively impact treatment.

In this study, participants were able to recognize Parkinson’s disease symptoms. But misinformation and a lack of understanding of the disease were high. More than half of participants “did not know the body part related to PD. Nearly nineteen percent (71/377) reported that degeneration was responsible for the disease, while 10.1% (38/377) reported it was due to lack of blood supply to the brain.”

This can lead to stigmatization of the disease, which makes it even more difficult to treat.

The authors concluded that: “Public health approaches that improve knowledge are urgently needed to promote care access and community response to Parkinson’s disease” in Uganda. By providing access to information about Parkinson’s disease, it might be possible to improve the treatment of it.

Barriers in Malaysia

Another corner of the earth that has little information circulating about Parkinson’s disease is Malaysia. A 2015 study published in the Journal of Parkinson’s Disease examined the barriers associated with misinformation and lack of knowledge about Parkinson’s disease in that country. The study’s abstract claimed that, “This is the only study on public knowledge regarding PD in Asia,” illuminating how little research was being conducted on Parkinson’s in the region at the time.

Like many of the study participants in Uganda, respondents in Malaysia reported that they also were privy to misinformation: “PD patients (n=116) and caregivers (n=135) demonstrated superior knowledge compared with the general public group, but one-third of them believed that PD is currently curable.”

While the study’s participants exhibited familiarity with Parkinson’s symptoms, there was still a lot of misinformation circulating among them, according to researchers.

This study also showed that participants in Malaysia conveyed inaccurate information about Parkinson’s disease: “Important gaps in knowledge were evident, which could present a barrier to early diagnosis and appropriate treatment of PD,” the study’s authors noted. “This highlights the need for targeted education campaigns and further research in this area.”

Greater information access

Despite advancements in the treatment of Parkinson’s, some regions of the world face significant barriers in diagnosing and treating it. Due to stigmatization of the disease, misinformation, and a lack of information, it can be difficult to identify and treat the disease’s symptoms.

But there is still hope. While Parkinson’s disease is currently incurable, recognizing the disease in its early stages might help to better manage it. Both of these studies suggested that providing greater access to information about the disease might encourage an earlier diagnosis among patients.


Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

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Antioxidant Nanoparticle Shows Promise in Lowering Oxidative Stress in Parkinson’s


Encapsulating the antioxidant small molecule ellagic acid into a nanoparticle that also has some antioxidant properties may be a promising approach to treat neurodegenerative conditions, such as Parkinson’s disease, in which oxidative stress plays a critical role, a study suggests.

In addition to reducing reactive oxygen species (ROS) — which when not cleared properly results in oxidative stress — and ROS-induced cell death better than any compound used alone, the approach also mitigated the toxicity of ellagic acid to cells, which has largely prevented its clinical development to date.

The study, “Chitosan-Ellagic acid Nanohybrid for mitigating rotenone-induced oxidative stress,” was published in the journal ACS Applied Materials and Interfaces.

Oxidative stress, or the imbalance between the production and clearance of toxic reactive species that are harmful to cells, such as ROS, is thought to play a key role in neurodegenerative diseases like Parkinson’s.

These toxic substances are increased as a result of deficient mitochondria (the cell’s powerhouses) and are thought to damage dopamine-producing neurons in Parkinson’s, eventually causing them to die.

Antioxidant small molecules found in nature, such as ellagic acid, are seen as a promising way to reduce the oxidative stress and nerve cell damage observed in patients, but because most of these molecules are not very soluble, patients would need to receive high doses, which can be toxic.

Researchers at The University of Texas at El Paso investigated whether encapsulating ellagic acid into a nanoparticle could reduce its toxicity while retaining its antioxidant properties. But instead of using a synthetic compound to create the particle, the team turned to chitosan, a biodegradable sugar molecule found in the hard outer skeleton of shellfish.

Notably, chitosan also has some antioxidant properties, which could improve the therapeutic effects of this approach.

After designing and developing their antioxidant nanoparticle, researchers tested their approach in cells cultured with rotenone, a pesticide known to inhibit the function of mitochondria and to induce oxidative stress. Rotenone often is used in animals to induce Parkinson’s-like symptoms.

Overall, the team found that the encapsulated formulation lowered the levels of toxic reactive species more efficiently, and prevented rotenone-induced neuronal cell death more than the nanoparticles alone or ellagic acid alone.

Also, while ellagic acid killed about 15% of cells in culture, nearly no cells died when cultured with the encapsulated formulation of this antioxidant.

“The results suggest that EA [ellagic acid] entrapped in chitosan-based nanoparticle system can serve as a better protecting agent against rotenone insult than EA alone,” the researchers wrote.

Importantly, the researchers noted that an ideal treatment should be able to release the active component in bursts, helping treat acute episodes of oxidative stress, and in a sustained manner given that reactive oxygen species are cleared up as they appear.

The team found that its nanoparticle system was able to do just that, releasing about 50% of ellagic acid in the first couple of hours, and then slowly releasing the remaining ellagic acid in the next 10 hours.

“This work creates a new type of bio-friendly drug-delivery vehicle made of recyclable materials,” Mahesh Narayan, PhD, who co-led the study, said in a press release. “The other special feature of this vehicle is that it can deliver the drug via two mechanisms: one rapid and the other a slow-release.”

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During COVID-19 Outbreak, MJFF Creates Information and Resource Hub

COVID-19 and Parkinson's

To support the global Parkinson’s disease community during the COVID-19 pandemic, The Michael J. Fox Foundation (MJFF) is spotlighting its new information and resource hub.

The dedicated site includes webinarspodcasts, online educational events, insights and tips regarding PD and the coronavirus, and a virtual events hub to see how the community is staying connected.

“COVID-19 is testing us all in ways we never imagined,” said Michael J. Foxactor and MJFF founder, in a video accompanying the announcement. “Around the globe, individuals, families, and nations are rising to this challenge with courage and grace. “…Together we will pull through this, and be stronger than ever.”

Today (April 29) at noon EDT, the organization will present a 30-minute webinar about how to participate in Fox Insight, the MJFF’s online clinical study aimed at providing the research community with critical insight into the experience, genetics, and variability of Parkinson’s. (Register here.)

Recent webinars are now available on demand and via podcast. In one, panelists discuss how the Parkinson’s care and research community is responding to COVID-19, as well as actions patients and caregivers can take during the pandemic. In another, experts discuss strategies — including mindfulness and meditation — for coping with Parkinson’s during this uncertain time.

The hub also features educational events from the MJFF’s Parkinson’s IQ + You sessions, which have been moved online. In collaboration with the Parkinson’s Disease Education Consortium, an on-demand presentation discusses telemedicine and how it can work for Parkinson’s patients. The event also features a conversation with a patient and care partner about optimizing virtual doctor visits.

In the MJFF’s “Ask the MD” program, Rachel Dolhun, MD and vice president of MJFF medical communications, offers practical tips and insights on COVID-19 and Parkinson’s disease. Topics include “Coronavirus and Parkinson’s,” “Staying Active,” “Easing Mood Changes and Isolation,” Living with Parkinson’s Amid the Coronavirus Pandemic,” “Smell Loss in Coronavirus and Parkinson’s Disease,” “What We Know and Don’t Yet Know,” and “Making the Most of Your Telemedicine Doctor Visit.”

For more information and updates on managing your health during this unprecedented period, you can follow the MJFF on Facebook, Instagram and Twitter. Patients and caregivers are invited to share across those sites how they are coping. Responses could be featured in the #TogetherAtHome global campaign that seeks to encourage a united pandemic front.

Because many institutions are prioritizing the public health crisis, many foundation grantees are feeling the pinch. That motivated the MJFF to establish for scientists FAQs: Coronavirus (COVID-19) & Research Support. The site is for current grantees and applicants, and answers questions related to COVID-19.

“Our commitment to these researchers, and to you, is to keep critical Parkinson’s research moving forward with as little disruption as possible by being flexible and responsive to their needs as the situation evolves,” the foundation stated. “Our staff continues to work with urgency and determination to move our programs forward.”

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Surge in Telemedicine One ‘Good’ Outcome from COVID-19 Crisis, Doctors Say


While there are few silver linings to the cloud created by COVID-19, the pandemic that has killed tens of thousands, hobbled economies worldwide and drove millions to quarantine in their homes, one may be a new appreciation of telemedicine.

“If something good could come out of this crisis, it’s that we would learn how valuable telehealth could be to our community,” said Steven Shook, a neurologist at the Cleveland Clinic in Ohio. Shook specializes in neuromuscular disorders such as Parkinson’s, muscular dystrophy, myasthenia gravisspinal muscular atrophy (SMA), and amyloid lateral sclerosis (ALS), and in polyneuropathy.

Dr. Steven Shook, Cleveland Clinic
Steven Shook, MD, (Photo courtesy of the Cleveland Clinic)

“People are going to want more — they’re going to want it to continue to be part of their medical care,” Shook said in a phone interview with BioNews Services, the parent company of this website.

Telemedicine is the use of technology, devices like a laptop or desktop, telephone or smartphone, to connect directly with a healthcare professional — doctors, specialists, nurses, therapists, psychologists — from just about anywhere you can get a connection: your home, your car, your office.

It’s the doctor’s house call, 21st century style.

But it arguably took a pandemic to bring telemedicine to the fore.

COVID-19 is a highly contagious and utterly new coronavirus, and its arrival put doctors’ offices and hospital visits off-limits to all but emergency cases.

People who have chronic diseases or take treatments that weaken or suppress their immune systems — whether Crohn’s, Friedreich’s ataxia, lupus, lymphoma (and most cancers), multiple sclerosis, sarcoidosis, or scleroderma — are at special risk of infection. So are those with disorders of the airways, such as cystic fibrosis, pulmonary fibrosis, and COPD (chronic obstructive pulmonary disease).

“I will continue to use telemedicine as I did before: as a tool for when it is harmful for me to go in or I am unable to physically go in to see my physician,” said Jennifer Powell, a 51-year-old Californian with secondary progressive multiple sclerosis (SPMS). But “I still think it is very important to be seen in person.”

Jenn Powell, telemed
Jennifer Powell, who has SPMS, readying for a doctor’s visit at her California home. (Photo courtesy of Jenn Powell)

As access closed in recent weeks, healthcare professionals, policymakers, and patients started taking a fresh look at the potential of telemedicine — video encounters, phone conversations, and e-visits (email-like exchanges) — to meet everyday health needs, from routine checkups or procedural follow-ups, to prescribing or refilling medications.

Shook’s use of telemedicine rocketed from “about 5% of my personal practice” as of late February, to “on March 16, a Monday, 100%. Excluding procedures I do, 100% of my new, involved visits are virtual.”

Jeff Gelblum, a board-certified neurologist and psychiatrist with First Choice Neurology near Miami, Florida, saw a similar, “fundamental pivot” in his work.

“Historically, I would do one televisit a day, mostly for people who were busy or working or out of town,” Gelblum said. “Now I’m doing 20 televisits a day for people self-quarantining at home.”

A crucial policy shift, at a critical time

If a virus was the impetus, two changes to U.S. government rules concerning telemedicine — how it might be used, where its use could be reimbursed — were the linchpin.

The federal Centers for Medicare & Medicaid Services opened access to telemedicine and a provider’s right to be paid for such services to all Medicare users, at rates equivalent to an in-person office visit, in a March 17 announcement.

Before this order, retroactive to March 6, reimbursement was largely restricted to televisits with people in “designated” rural areas.

At the same time, the U.S. Department of Health and Human Services waived HIPAA (Health Insurance Portability and Accountability Act) enforcement and penalties concerning the type of systems that could transmit or store personal medical data. This allowed “providers that serve patients in good faith” to use “everyday communications technologies, such as Apple FaceTime or Skype.”

Both revisions stand “on a temporary and emergency basis,” meaning they might be in place only for the duration of the current crisis.

Rakhee Langer
Rakhee Langer (Photo courtesy of eClinical Works)

Reimbursement probably was “the most important” change, said Rakhee Langer, vice president for healow, a telemedicine platform offered by eClinical Works, a healthcare technology company based in Westborough, Massachusetts.

Demand on healow, a secure, HIPAA-compliant, and multi-feature app used by more than 40,000 physicians across the U.S., went from an average of 100,000 daily usage minutes in January through early March, to 1.5 million minutes daily starting at mid-month, Langer said.

“I think there’s going to be continued adoption,” she said. “The patients and doctors have crossed the technology hurdle.”

Similar shifts are being reported across Europe, with countries that include France, Germany, and the U.K. moving to ease their own reimbursement and privacy restrictions. But the European Union’s regulatory environment and mix of state-run health systems has, until the pandemic, been less welcoming of telemedicine than in the U.S.

“What I would love to see is the government to take a good, hard look at the value we deliver during this period of time, and to consider not rolling back those changes,” Shook said.

Telemedicine at its best: ease and convenience

Ease of use, for both healthcare providers and patients, is one of the most important features of telemedicine.

Shook remembers being outfitted with “a special camera, a special microphone” when this service first came into use at the Cleveland Clinic in 2014. Today, he finds he’s “gotten very comfortable with using my cellphone.”

Convenience, the ability to connect to a doctor without leaving where you are, arriving at an office and waiting in a chair, is another.

Britt Foster, PH
Brittany Foster (Photo courtesy of Britt Foster)

Telemedicine “keeps me from having to drive — sometimes over an hour away — to a specialist, so it is saving in travel and expenses,” said Brittany Foster, 28, of Rhode Island, who was diagnosed with pulmonary hypertension due to congenital heart disease shortly after her birth, and with Currarino syndrome, a rare genetic disease typically affecting the lower spine (sacrum), rectum, or presacral soft tissues, at age 3.

“The doctors are usually on time, from my experience, when it comes to telemed,” she said. “There’s no need to wait around in an office … which saves my own anxious thoughts.”

But it’s not just 20-, 30-, or 40-year-olds who might appreciate the technology and what it can offer. Older people may stand to benefit the most.

Younger patients, including millennials “who obviously have mobile devices, some literally attached to their bodies,” were the first to adopt telemedicine, Shook said. “But I’m noticing that my patients who are older … people who never even thought of doing this before, are really impressed by how easy it is to do.”

My “ALS patients are a great example of how we can connect … and provide excellent care virtually,” he added. “It’s very hard for them to get back and forth between their home and the clinic.”

“Historically, Medicare refused to avail patients of telehealth. Why? I don’t know,” said Gelblum, whose patients include those with Parkinson’s and Alzheimer’s. “Because Medicare beneficiaries being older and more informed would have the greatest difficulty physically going to the doctor.”

The Cleveland Clinic’s platforms are AmericanWell (amwell) and Express Care Online, which — like healow, which Gelblum uses at First Choice — are well-integrated into their respective centers’ electronic health (or medical) records (EHR/EMR) system.

All three platforms are secure, compliant, and largely walk people through initial steps of any medical visit: sending out appointment notices or reminders that include links, and filling out a health questionnaire for a doctor to review before inviting the patient “into the office.”

They allow a provider to pull up charts, lab results, imaging scans, and other records; an invite is sent once everything’s ready. Both also support wearable apps that can monitor issues such as gait or tremor,  and — if a patient has the necessary tools — can instantly display blood pressure, blood-oxygen levels (pulse oximeter), or heart rate measures.

“In my patient population, a lot are visually challenged, memory challenged, dexterity challenged,” said Gelblum, whose oldest televisit patient is 102. “Simplicity is crucial.”

Dr. Jeffrey Gelblum
Jeffrey Gelblum, MD, (Photo courtesy of First Choice Neurology)

Security is also crucial, and Gelblum disagreed with the government’s opening of telemedicine to popular platforms, like FaceTime or Skype, created for social media.

“You’re allowed to drink a whole bottle of Scotch, but that doesn’t necessarily make it a health choice,” he said. “I think it’s important to remember that, even though … these platforms exist, they don’t always exist for the benefit of the user, or for the benefit of a patient.”

But the need to ramp up a large country, with an estimated 100 million people with chronic conditions, and shift it virtually overnight from face-to-face visits to video or telephone care likely left little choice.

Shook said the Cleveland Clinic’s systems were overwhelmed with demand in mid-March, and its technology department settled on adding FaceTime and Google Duo for their popularity, and “as the most secure from an ITD [information technology department] standpoint.”

He expects that his academic institute’s goal is to return fully to its secure and traditionally HIPAA-compliant platforms.

Looking ahead

People with chronic diseases whom we talked to, all who also work with BioNews, favor the convenience of telemedicine as an alternative form of essential care.

“I think that it is great to have telemed as an option. Particularly for the days when I am not feeling my best,” Foster said. On “a follow-up appointment, for example, it seems like I am simply updating the doctor on my status when that can be said over a phone call or check-in email.”

Still, she mentioned being able to better hide possibly serious health concerns when using the medium. “Over the phone,” she said, “I can paint a picture that everything is ‘great’ due to wanting to avoid a hospital admission or wanting to avoid care out of fear.”

Televisits conducted by caregivers who know her well, however, usually don’t allow skipping pointed discussions. And her “doctors usually ask about vital signs,” she added, even though “self-monitoring equipment isn’t something that was ever offered.”

Powell worried that doctors and patients alike would favor the “convenience of a diagnosis or prescription without leaving your home,” and forego “a thorough examination.”

Her own doctors have been vigilant in not allowing her to sidestep essential visits, she said. “However, it’s a slippery slope that is only as good as the institution implementing the telemedicine.”

But the “good outweighs the bad,” she added, especially for those “with weakened immune systems or … trouble with mobility.”

Shook and Gelblum agreed, emphasizing that, once a relationship is established with a patient, many routine exams — across diseases — can be conducted online.

“I don’t think we’re going to ever completely replace that human-to-human interaction that’s so critical in medicine,” Shook said, “but I do think that some of the work we do can be done very effectively on a virtual platform.”

Telemedicine’s “greatest advantage,” said Gelblum, “is that it promotes accessibility in medical care. … Accessibility to care is an enormous hurdle, and that is probably the greatest reason why people get sick.”

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Tool Can Help Guide Palliative Care Decisions in Parkinson’s, Study Says

palliative care

A new tool, based on multiple signs of disease progression, can help guide healthcare professionals in decisions on when to start palliative care for people with Parkinson’s, researchers report.

Their study,”RADPAC-PD: A tool to support healthcare professionals in timely identifying palliative care needs of people with Parkinson’s disease,” was published in PLOS ONE.

Palliative care broadly refers to medical care that aims to improve comfort and life quality for people with serious diseases and their families. There is a widely recognized need for this kind of care in Parkinson’s, particularly at more advanced disease stages.

However, deciding when to start palliative care in Parkinson’s can be difficult, particularly because cognitive abilities are often affected in advanced stages, limiting a person’s capacity to participate in decisions about their own treatment. There is a need for tools that can guide patients and healthcare professionals on when best to start talking about, and implementing, palliative care.

Researchers at Radboud University in the Netherlands began work on such a tool with a series of focus groups and interviews with healthcare professionals who had expertise in treating Parkinson’s and/or providing palliative care. Based on information gleaned from these discussions, the researchers then conducted a Delphi study.

This type of study involves giving the same group of people a questionnaire several times, with the questions modified each time based on previous responses. In this case, a panel of 51 healthcare professionals were asked questions about palliative care and Parkinson’s disease three times, with continuously revised questions.

Based on consensuses reached, the next step was to develop a tool, which the team called the RADboud indicators for PAlliative Care Needs in Parkinson’s Disease (RADPAC-PD).

An important aspect of this tool, which was stressed in the early interviews, is that it provides guidance for two critical moments related to palliative care.

The first critical moment is when to start Advance Care Planning (ACP), or discussions with patients about what kind of care they would like to receive in the future. It was noted that many healthcare professionals are hesitant to have these conversations too early, as they can cause undue stress and psychological burden.  But waiting too late risks a patient’s cognitive decline and inability to express personal preferences.

The RADPAC-PD outlines six indicators for starting ACP: a request for ACP on the part of the patient, the patient expressing feelings of hopelessness or dread of the future, more frequent falls, difficulty swallowing (dysphagia), detectable cognitive problems or psychological issues, and a first unplanned hospital visit.

If at least two of these indicators are present, the RADPAC-PD recommends beginning conversations around ACP.

The second critical moment defined on the RADPAC-PD is the initiation of palliative care itself. Here, four indicators were proposed: the goal of care moving towards maximizing comfort, a transition in care needs (e.g., nursing home admission or increasing at-home help), Parkinson’s-specific treatments becoming less effective or more complex, and the progression of certain Parkinson’s-specific symptoms (including dysphagia, frequent falls, and significant weight loss).

If at least one of these indicators is present, the RADPAC-PD recommends commencing palliative care.

“This study describes the systematic development of the RADPAC-PD based on qualitative research and a Delphi study,” the researchers concluded. “We expect that applying the RADPAC-PD, for example on an annual basis throughout the PD trajectory, can facilitate identification of the palliative phase in PD patients in daily practice.”

But, they added, “We do not yet have evidence about the applicability of this instrument. We acknowledge that further research is needed on the implementation of the RADPAC-PD.”

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ANVS401 Improves Colonic Motility in Mouse Models of Early Parkinson’s

mouse study ANVS401

Investigational therapy ANVS401 (also known as Posiphen) reversed gastrointestinal dysfunction linked to early Parkinson’s in two mouse models of the disease.

Results of the study, “Translational inhibition of α-synuclein by Posiphen normalizes distal colon motility in transgenic Parkinson mice,” were published in the American Journal of Neurodegenerative Disease.

Parkinson’s disease is characterized by aggregates of alpha-synuclein in the nervous system, particularly in dopamine-producing neurons in the brain. How these aggregates form in the first place, however, is not fully understood.

One proposed hypothesis is that the aggregates don’t initially form in the brain, but in the enteric nervous system (ENS) — the nervous system of the gut.

This is supported by the fact that gastrointestinal dysfunction can occur decades before the onset of motor symptoms. Common gastrointestinal symptoms include dysphagia (difficulty swallowing), gastroparesis (slow movement of the stomach muscles), longer gut transit time (time between ingestion of food and its excretion as feces), constipation, and difficulty with defecation.

ANVS401, developed by Annovis Bio (previously known as QR Pharma), is an oral medication that stops the production of alpha-synuclein protein. It does so by binding to SNCA mRNA — a molecule that serves as a template for protein production — and preventing it from being translated into alpha-synuclein by the cell’s protein-making machinery. (Translation is the process by which the genetic information contained within a gene, in this case SNCA, gives rise to a protein.)

Previous in vitro studies in human and rodent nerve cells have shown that ANVS401 can reduce alpha-synuclein protein levels in those cells. However, no preclinical studies of the effects of ANVS401 in animal models of Parkinson’s disease existed.

Now, researchers at the University of California San Francisco, in a study funded by the Michael J. Fox Foundation, tested the effectiveness of ANVS401 to reverse gastrointestinal dysfunction in two mouse models of SNCA-associated early Parkinson’s disease. 

“What we have here is a very early model of PD [Parkinson’s disease], where alpha-synuclein accumulates in the enteric nervous system and causes defects in gut motility,” the researchers wrote.

The team also studied ANVS401’s pharmacokinetics and pharmacodynamics — how the body affects a medicine and the interactions between the body and a medicine. 

The results showed that in both mouse models, ANVS401 prevented slowing in colonic motility (the amount of time it takes for material to move through the colon). This positive effect was kept for at least nine weeks after ANVS401 treatment was stopped.

“This may be indicative of the time it takes α [alpha]-synuclein to accumulate and cause gastrointestinal dysfunction,” the researchers wrote.

However, whole gut transit time — the time it takes for food to leave the stomach and go through the small bowel and colon  — was not changed by ANVS401 treatment. The weight of the mice also remained unchanged.

Importantly, while lower doses of ANVS401 (10 mg/kg) reduced the levels of alpha-synuclein in the gut of mice treated for 21 weeks, higher doses (50 and 65 mg/kg) reduced alpha-synuclein levels in the brain of mice treated for a much shorter period of time (21 days).

This suggests that ANVS401 acts over a longer period of time in the gut and may help researchers calculate its appropriate dose to be used in future clinical trials so the treatment can “be effective, and less probable to cause side effects.”

Overall, the data “are in agreement with the ability of Posiphen to reach the nervous system, and its mechanism of action, the translational inhibition of α [alpha]-synuclein,” the researchers wrote.

“ANVS401 lowered levels of α[alpha]-synuclein and normalized gut motility in two transgenic animal models of PD [Parkinson’s disease]. Together, these data are very exciting and provide strong support for moving forward in our development of ANVS401,” Maria Maccecchini, PhD, CEO of Annovis Bio said in a press release.

Annovis Bio now is planning a multi-center, randomized, double-blind, placebo-controlled Phase 2a trial evaluating the safety and tolerability of ANVS401 in patients with early Parkinson’s disease.

The compound already is being tested in a Phase 2 clinical trial (NCT02925650), called DISCOVER, in people with early stage or probable Alzheimer’s disease.

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Industry leaders seek to advance innovative resources for rare and orphan disease communities amid COVID-19 outbreak

FFF Enterprises and BioNews announced today that both rare and orphan disease advocates are joining forces to provide patients with resources to help them connect as a community and continue to manage their health during this time when many are finding themselves alone.

Recognized as the nation’s leading supplier of critical-care biopharmaceuticals, plasma products and vaccines, FFF has been pro-active in communicating with pharmaceutical manufacturers across the country, ensuring that patients do not experience interruptions in receiving the lifesaving medicines they need. Through their discussions with patient advocates and industry leaders alike, FFF has identified newly emerging needs for serving rare and orphan disease patient communities during this unprecedented time in history, when isolation and a limitation in treatment options can be difficult.

“Many of the patients we serve have spent years ‘self-quarantining’ themselves during flu season or when they felt their immune systems were comprised,” states Patrick M. Schmidt, CEO of FFF Enterprises.” What they haven’t experienced before is the social isolation that comes from a pandemic like COVID-19, and many are scared, even afraid, to let a nurse come to their home for treatments.”

The mandate to self-quarantine has not only led to social isolation for these patients, but also in many cases an abrupt halt to participation in critical clinical trials that are advancing potentially life-changing, novel therapies. In a direct response to this, FFF is seeking to partner with digital leaders who have built uniquely deep reach into these patient communities online. “We felt a call to action was needed across a broad range of rare disease spaces to help patients connect and know they are not alone in addressing these essential needs,” Schmidt explained, adding that, “BioNews and its unparalleled commitment to serving so many of these communities supported our burgeoning mission.”

BioNews Services,  the online leader in creating authoritative, authentic news and perspectives platforms for rare and orphan disease communities, brings its robust network of niche, disease-specific websites and proven outreach capabilities to the partnership, and will play the leading role in connecting patients with community and health resources that will foster communication and participation in improving the health and lives of patients worldwide. With over 65 active websites that publish reliable news and intimate perspectives written by patients themselves daily, the company continues to note a dramatic increase in the need for “connection” since the onset of COVID-19.

“Throughout the years of serving rare and orphan disease communities, BioNews recognizes how isolating it is for those who suffer from a chronic, progressive disease day in and day out,” Mike Nace, President of BioNews, noted. “Together through our new and growing partnership with FFF Enterprises, we are looking forward to bringing our closeness and familiarity with patient communities to bear with FFF’s unique suite of patient-centric services to help connect and reconnect patients to their support communities as well as clinical trials and other essential resources for supporting their health and well-being through the COVID-19 epidemic.”

Moving forward, FFF and BioNews will continue to make it their mission to serve rare and orphan patients during the pandemic and beyond  by providing knowledge, insight and hope to be a glimmer of light when isolation often proves to be dark for those most in need.

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FDA Approves Ongentys as Levodopa Add-on for ‘Off’ Periods

Ongentys and FDA approval

The U.S. Food and Drug Administration (FDA) has approved Ongentys (opicapone) as an oral, add-on daily treatment for Parkinson’s disease patients experiencing off periods while on a levodopa/carbidopa regimen.

The approval is for 25 mg and 50 mg capsules, either taken once a day. It comes after Ongentys significantly reduced off periods — when the effects of a medication wear off before a new dose can be taken — and extended the periods of on-time without involuntary movements (dyskinesia) compared to placebo in two Phase 3 trials.

Neurocrine Biosciences, which owns the rights to Ongentys in North America, plans to launch the therapy later this year.

“The FDA approval of Ongentys provides patients living with Parkinson’s disease with an important new treatment option to help manage the disruptive and unpredictable motor fluctuations by decreasing ‘off’ episodes and increasing ‘on’ time without troublesome dyskinesia when taking levodopa/carbidopa,” Kevin C. Gorman, PhD, CEO of Neurocrine Biosciences, said in a press release.

Levodopa is considered the gold-standard treatment for Parkinson’s. However, several years after starting the medication, patients often begin experiencing fluctuations in their motor symptoms caused by a faster wearing off of the treatment’s effects. This means that the intervals in which symptoms are adequately controlled, called ‘on periods,’ become progressively shorter.

Levodopa can be converted to dopamine, counteracting the loss of dopamine-producing neurons in the brain, a hallmark of Parkinson’s. But dopamine cannot cross the blood-brain barrier, a semipermeable membrane that protects the brain from the external environment, so levodopa needs to reach the brain before being converted.

Ongentys works to increase the amount of levodopa reaching the brain by blocking an enzyme, called catechol-o-methyltransferase (COMT), that breaks down levodopa in the blood. This is expected to prolong levodopa’s effectiveness.

“As Parkinson’s disease progresses, first-line treatments such as levodopa begin to lose effectiveness and the beneficial effects of levodopa begin to wear off more quickly, causing more frequent and often debilitating motor fluctuations in patients,” said Robert A. Hauser, MD, a professor at the University of South Florida Parkinson’s Disease and Movement Disorders Center.

“Clinical studies have shown that adding once-daily Ongentys to levodopa therapy significantly reduced ‘off’ time, leading to better and more consistent motor symptom control,” Hauser added.

Ongentys is approved in Europe for Parkinson’s disease patients using levodopa or combinations of similar therapies, who experience motor symptoms before the next treatment dose is due. In Europe, the medicine is marketed by Bial.

The FDA’s approval was supported by 38 clinical trials, including two multinational Phase 3 trials — BIPARK-1 (NCT01568073) and BIPARK-2 (NCT01227655) — that included more than 1,000 Parkinson’s patients treated with Ongentys.

These two trials included patients diagnosed at least three years ago, who had been experiencing fluctuations in motor symptoms — off time of at least 1.5 hours daily while awake — despite being on a stable levodopa/carbidopa regimen.

In BIPARK-1, 600 patients were randomly assigned to either one of three Ongentys doses — 5 mg, 25 mg, or 50 mg — or to another COMT inhibitor called Comtan (entacapone, marketed by Novartis), or to a placebo.

Treatment was given over 14 to 15 weeks while patients continued with their levodopa/carbidopa regimen. Its main goal was to determine whether Ongentys was better than a placebo at reducing off time. Secondary objectives included additional measures of motor and non-motor symptoms, as well as sleep problems.

BIPARK-1’s results demonstrated that both 50 mg Ongentys and Comtan significantly decreased the duration of daily off periods and increased “on time” without troublesome dyskinesia, compared to a placebo. However, unlike Comtan,  opicapone led to favorable ratings in both the Patient Global Impression of Change (PGI-C) — which reflects a patient’s beliefs about the efficacy of treatment — and the Clinical Global Impression of Change (CGI-C) — which evaluates overall illness severity and clinical changes in the condition over time.

BIPARK-2 included 400 people given either a 25 mg or 50 mg dose of Ongentys, or a placebo for 14 to 15 weeks. Results were similar to those of BIPARK-1, with patients on the 50 mg dose showing an absolute on-time without dyskinesia of 1.7 hours, compared to 0.9 hours in the placebo group.

An open-label extension of BIPARK-1 and BIPARK-1 later showed that a 25 mg dose continued to show reductions in off time and increases in on periods over one year of treatment, regardless of whether patients had been randomized to Ongentys or to placebo in the double-blind part of the main trials.

The most common side effects in both studies were dyskinesia, constipation, an increase in blood creatine kinase, low blood pressure, and weight loss.

“Due to the progressive nature of Parkinson’s disease, those living with the condition often struggle to control their motor fluctuations, affecting a wide range of functions, including speech, balance and movement, which adversely impact many aspects of life,” said John L. Lehr, president and CEO of the Parkinson’s Foundation.

“The Parkinson’s disease community is encouraged by the FDA approval of a new add-on treatment option to help patients further control symptoms, enabling them to better cope with this progressive disease,” Lehr added.

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