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Focused-ultrasound Lesion Surgery Can Treat Tremors and Improve Life Quality, Study Says

tremors and surgery

Treating tremor in Parkinson’s patients using non-invasive and focused-ultrasound lesion surgery is associated with better quality of life when compared to deep brain stimulation, although both approaches are equally effective in easing this disease symptom, a review study reports.

The study, “Outcomes in Lesion Surgery versus Deep Brain Stimulation in Patients with Tremor: A Systematic Review and Meta-analysis,” was published in the journal World Neurosurgery.

At least 50 percent of people with Parkinson’s, essential tremor (ET) or multiple sclerosis (MS) given oral medications as a first-line treatment for tremor — defined as an involuntary, uncontrollable muscle contraction; most commonly in the hands — do not tolerate these medications over the long term.

Current alternatives include deep brain stimulation (DBS) and lesion surgery (LS), which induces lesions on targeted areas using a heated electrode or focused ultrasound. Prior comparisons have shown that while the two techniques are equally effective in suppressing tremor, DBS led to a greater improvement in function.

But LS with focused ultrasound is gaining in popularity, and one study suggested that it may significantly improve tremor and quality of life.

Researchers at Harvard Medical School conduced a systematic review and a meta-analysis — a type of statistical study that combines the results of various studies — to determine which strategy is most effective in diminishing tremor severity and improving life quality and function in people with Parkinson’s, ET, or MS.

Three online databases were searched for results of randomized clinical trials published up to Jan. 1, 2018, and that included adults treated with either LS or DBS, or serving as controls. Both DBS and LS studies targeted unilateral or bilateral thalamus, pallidum or subthalamic nucleus, all of which are implicated in motor function.

Thirteen Parkinson’s trials were among the 15 included in this study, and the primary outcome for all but one was change in upper limb tremor severity, as assessed with the unified Parkinson’s disease rating scale (UPDRS) part III. Changes in quality of life, cognitive function and neuropsychiatric function were also assessed with variable measures.

A total of 1, 508 patients (mean age range, 48.4 to 70.8) were included, and in addition to the 13 studies involving only Parkinson’s patients, one study looked at people with Parkinson’s, ET and MS, while the remaining study was in people with severe ET.

Four of the 15 trials — involving 125 patients — directly compared DBS to LS. The others compared either LS or DBS with controls.

Results showed that DBS and LS were not significantly different across all analyzed outcomes, which is in line with current guidelines, the researchers noted. All but one trial showed both these types of surgery eased tremor severity. Quality of life findings showed variability in outcomes, which was driven by disease duration. Specifically, longer disease duration correlated with a greater likelihood of surgery and better quality of life.

A subgroup analysis that looked specifically at LS using focused ultrasound revealed that this approach was associated with a significant improvement in quality of life compared to DNS, although changes in tremor severity were similar.

“Policy makers, healthcare providers, and patients could therefore consider focused-ultrasound [LS] as a potential choice for tremor control, based on currently available evidence,” the researchers wrote.

However, results from more studies directly comparing DBS with focused-ultrasound LS are needed, they advised.

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Transient Cerebral Swelling a Common Side Effect of Deep Brain Stimulation, Study Suggests

brain edema DBS

Swelling of brain areas close to where the electrodes that deliver deep brain stimulation (DBS) are placed is a common and transient side effect of this treatment in Parkinson’s disease patients, a study suggests.

Long-term impact of this adverse reaction and potential related complications are still unknown and warrant further analysis, researchers say.

The study, “Peri-lead edema after DBS surgery for Parkinson’s disease: a prospective MRI study” was published in the European Journal of Neurology.

DBS is a surgical treatment in which thin wires are implanted in strategic brain areas (those that control complex movements) to deliver electrical impulses generated by a battery-operated device.

Studies have shown that DBS can be beneficial in treating a variety of neurological diseases, particularly Parkinson’s. DBS has been accepted as an effective therapy to reduce motor symptoms such as tremors, lower the necessary daily dose of medication and improve Parkinson’s patients’ quality of life.

The most common adverse events associated with DBS include hemorrhage, infection, and failure of the implant’s components. However, some studies have also reported rare events of cerebral swelling (edema) surrounding DBS electrodes a few days after the surgery.

To gain binsight on the prevalence of this complication, Italian researchers evaluated the progression of 19 Parkinson’s patients who had undergone DBS therapy.

Surgeries were uneventful in all patients, with no complications being reported. However, after surgery, two patients experienced small hemorrhages close to the placed electrodes without any other brain tissue alterations reported.

All patients were evaluated by magnetic resonance imaging (MRI) between days 7 and 20 after surgery.

Researchers found that all patients showed some degree of MRI signal alteration along the placed electrodes, which was consistent with edema. The analysis also revealed small symptomatic hemorrhage in four additional patients, raising the total number of hemorrhagic patients to six (31.57%).

Researchers failed to find any correlation between edema volume and patients’ age, gender, disease duration, or side of the brain in which DBS electrodes had been implanted.

Patients who had hemorrhages also showed tissue swelling on the side of the brain opposite the bleeding.

Most patients were asymptomatic, but six had transient confusional state — disorientation in space and time plus mild signs of frontal lobe dysfunction, which included disinhibition, inattentiveness, and slightly impaired speech with poor word retrieval. Patients did not show any new motor deficits after surgery.

Two symptomatic patients were treated with a short corticosteroid treatment, but no significant effect on symptoms was noted. Still, both patients recovered in two to four weeks.

At a mean time period of 40.64 days after surgery, MRI signs returned to normal values in eight  patients. Superficial edema was still detected in three patients. At follow-up, no patient had detectable bleeding around the DBS electrodes.

To further explore the prevalence of brain edema associated with DBS, the team retrospectively evaluated computed tomography (CT) imaging data of 77 patients who had undergone DBS surgery from January 2013 to February 2017.

Hemorrhage around DBS electrodes was detected in four (5.19%) patients and edema in six (7.78%) patients. In nine patients evaluated by CT scans on days 1, 2, and 3 after surgery, edema was present in two who also had hemorrhage, and another patient.

“Our prospective MRI study confirms that [transient] edema is a common finding in STN-DBS [subthalamic nucleus] implanted patients for Parkinson’s disease and that it is asymptomatic in most patients,” researchers said. “The reason of the extremely high incidence of our finding is likely due to the timing of imaging (average 10 days) from surgery.”

They stated their opinion that edema near the electrode sites “is a normal and constant finding in patients undergoing STN-DBS lead placement. Its recognition is biased mainly because it is mostly asymptomatic and also because of the lack of early routine MRI scans in DBS patients.”

The team suggested that to avoid overtreatment and complications, “no corticosteroid treatment should be administered to patients whose MRI shows … edema in the first 7 to 60 days from surgery.”

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Black Doggy Goes to the Doctor

“Why can’t I go?” asked my granddaughter, whom I call Boo.
“The doctor is trying to fix my brain and it won’t be any fun,” I replied as 3-year-old Boo looked at me curiously. I had undergone deep brain stimulation two weeks earlier for my Parkinson’s disease, and was scheduled to have my unit turned on and programmed.
It was a two-day drive down to Arizona where my movement disorder specialist was, then two days driving back home to southern Oregon.
The day before I left, Boo informed me that she still wanted to go with me to the specialist. Boo also told her mother the same thing when she came to pick her up. (I watched her every day while her parents were at work.) When her mommy said no, her little lips began to quiver and tears welled.
“Boo, the ride is really long and you really wouldn’t like it. How about the next time Grammy goes to her regular doctor here, you can come with me, OK?” I asked her.
That appeased my granddaughter for the time being and she left for home.
Later that evening, my husband and I drove over to Boo’s to say goodbye to the family because we were leaving in the morning. As we got ready to go back home, my son said, “Boo, isn’t there something you wanted to give Grammy to take with her to the doctor?”
Her face lit up and she ran to her room.
“She was still upset when we got home today about not being able to go with you to the doctor,” her mom told me as we waited for Boo to return. And then, here she came around the corner with Black Doggy. Black Doggy is Boo’s prized and favored little friend. Boo cannot sleep without Black Doggy. Boo cannot live without Black Doggy. Boo gave me Black Doggy.
“You can take Black Doggy with you to take care of you,” she told me as she handed him over.
I fought back tears. “Oh … but what will you do when you go to bed?”
“I’ll use Brown Doggy,” she said. My son winked at me and nodded his head.
“OK,” I said. I then asked, “Do you want to have Black Doggy’s picture taken with the doctor?”
Boo was beside herself. “Yeah, Grammy! Yeah!”
I gave Boo another big hug and we left. OK, so how was I going to pull this off without feeling utterly ridiculous? Who cares? Anything for Boo.
Two mornings later, I saw my doctor. Re-entering the exam room after doing some tests, my husband sat waiting and holding Black Doggy and the camera.
“OK,” he said as he stood up, “this is for Boo.”
“Oh, the grandchild! We can do that,” my doctor laughed and then smiled for the camera, holding Black Doggy.
Boo was so pleased with her picture. Sometimes all it takes to make things better is a stuffed black doggy.
***
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.

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DBS Effectively Reduces Tremor in Parkinson’s Patients, Regardless of Stimulated Brain Area, Study Shows

Parkinson's tremor

Deep brain stimulation (DBS) can effectively reduce tremor in people with Parkinson’s disease, regardless of the brain region stimulated, according to a recent review study.

The review, “STN vs. GPi deep brain stimulation for tremor suppression in Parkinson disease: A systematic review and meta-analysis,” was published in the journal Parkinsonism & Related Disorders.

Tremor is a main symptom of Parkinson’s disease, strongly affecting patients’ quality of life. It is estimated that 47-90% of Parkinson’s patients have an action tremor and 76-100% have a resting tremor.

Reduction of tremors is an important goal in Parkinson’s treatment, and could have a significant impact in patients’ well-being and everyday life. However, tremor is difficult to treat and often does not respond to anti-tremor medications.

Deep brain stimulation — electric stimulation in strategic brain areas through surgically implanted thin wires in the brain — is used to treat people with advanced Parkinson’s disease whose motor symptoms, such as tremors, are not reduced with medication.

Several studies have shown that DBS eases motor symptoms, reduces the necessary daily dose of medication, and improves patients’ quality of life.

Currently, the main approved targets for DBS in Parkinson disease are the subthalamic nucleus (STN) and the globus pallidus interna (GPi), areas of the brain involved in motor function.

While recent studies have found no significant differences between the therapeutic effects of the stimulation of both targets, many clinicians maintain an older preference for STN over GPi, due to a supposedly greater reduction in tremors and in medication.

However, evidence supporting STN-DBS superiority in tremor suppression is limited.

Researchers have conducted a systematic review of all randomized clinical studies comparing the therapeutic effects of STN-DBS and GPi-DBS on tremors in Parkinson’s patients, published before March 2017.

Their search identified five suitable longitudinal randomized control trials with five years follow-up data. The data included the two DBS targets, STN and GPi, and tremor sub-scores of the Unified Parkinson’s Disease Rating Scale (UPDRS) before and after DBS, and with or without dopaminergic medication.

Their analysis showed that deep brain stimulation significantly reduced tremor symptoms in Parkinson’s patients, and that these effects were observed regardless of medication status.

When looking at the two targets of deep brain stimulation, researchers found that both methods reduced tremor severity in Parkinson’s patients, with no significant differences between them. These results support that DBS of each target promotes similar long-term benefits on tremor.

However, analysis of therapeutic effects on tremor over the course of five years showed that STN-DBS was more effective to reduce tremors after two and five years than at the first six months. In turn, GPi-DBS showed a more stable degree of effectiveness on tremors over time.

“Although both targets were effective, practitioners should be aware that it is possible one target could appear superior in studies depending on the duration of follow-up,” researchers wrote.

They also noted that when Parkinson’s patients present with tremor as the primary complaint, or as an issue adversely affecting quality of life, selection of deep brain stimulation target should focus on the presence of other problems “such as cognitive impairment, speech difficulties, presence of mood disorders, and presence of impulse control disorders.”

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DBS Linked to Distinct Motor and Cognitive Pathways in Brain, Finding That May Improve Its Use

deep brain stimulation

The benefits of deep brain stimulation (DBS) on motor function in Parkinson’s patients are mediated by a different brain pathway than the one involved in the procedure’s unwanted cognitive effects, according to a new study.

This finding may help improve the effectiveness and safety of DBS use in patients with Parkinson’s disease.

The research, “Functional segregation of basal ganglia pathways in Parkinson’s disease,” was published in the journal Brain.

DBS is an efficient alternative surgical procedure to treat Parkinson’s motor symptoms, such as tremor, rigidity, stiffness and slowed movement, in patients with an inadequate response to medications.

The treatment targets the subthalamic nucleus (STN), a brain region that is hyperactive in Parkinson’s patients. Besides its role in motor control, the STN is also involved in cognitive processes such as decision-making.

Prior research has shown that the STN is part of a brain pathway linking the striatum — a key region in movement and cognition — to the thalamus, which relays motor and sensory signals. This pathway is affected by loss of the neurotransmitter dopamine in the striatum due to Parkinson’s.

The STN is also involved in a brain pathway connecting motor-related areas in the cerebral cortex with the globus pallidus, a major component of the basal ganglia, which is mainly implicated in the control of movement and posture. The STN has been proposed to act through this pathway to delay, and thereby optimize, behavioral responses.

Although researchers suggest that DBS may alter the activity of both these brain pathways, no study had assessed the treatment’s effects on cognition and movement control in an integrated perspective.

A research team from Charité – Universitätsmedizin Berlin, in Germany, combined behavioral experiments with clinical observations, brain mapping and computer-based modeling. The study involved 20 Parkinson’s patients (18 men, mean age 63) undergoing STN-DBS, and 20 controls given a tracking task that required normal (automatic) and controlled reach movements.

Improvements in motor function — such as in movement velocity — were independent from unwanted cognitive effects, such as premature actions taken in situations requiring deliberation and decision-making. These motor and cognitive effects were independently mediated by the striatum-thalamus and the cortex-globus pallidus pathways, respectively.

“Our findings integrate with previous reports regarding cognitive and clinical implications of distinct pathway effects in Parkinson’s,” the researchers wrote.

Besides a better understanding of the neuronal networks affected by Parkinson’s, the findings also shed light on the workings of DBS.

“Only an improved understanding of the treatment’s mechanism of action will allow us to make [DBS] more effective,” Wolf-Julian Neumann, MD, the study’s first author, said in a press release.

As such, the results “may inspire new innovative pathway-specific approaches to reduce side effects and increase therapeutic efficacy of neuromodulation in patients with Parkinson’s,” the researchers wrote.

The team is now planning to use measurements of neural activity to differentiate patients and healthy individuals.

“This will allow us to adapt brain stimulation treatments according to the needs of the individual patient and in real time,” said Andrea A. Kühn, MD, the study’s senior author. “It is an important step on the way to developing an intelligent, personalized and demand-adapted treatment.”

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Magnetic Gene in Fish May Help Develop New Treatment Strategies for Parkinson’s, Study Says

magnetic gene in fish

A fish that can sense the Earth’s magnetic field while it swims could help scientists understand how the human brain works and eventually unlock strategies to help control movement impairments in patients with Parkinson’s disease and other neurological disorders, a study reports.

The study, “Wireless control of cellular function by activation of a novel protein responsive to electromagnetic fields,” was published in the journal Scientific Reports.

The freshwater glass catfish, also known as Kryptopterus bicirrhis, is capable of sensing and responding to the Earth’s electromagnetic fields.

Michigan State University (MSU) researchers were able to identify this “navigational gene,” called the electromagnetic-perceptive gene, or EPG. The protein produced by the EPG senses both static and alternating magnetic waves, allowing the fish to swim away in response to magnetic fields.

The team injected a virus containing the EPG into motor neurons located in one of the main regions of the brain involved in motor function, called the right primary motor cortex, of 10 adult rats. Five control rats were injected with a virus that had a fluorescent protein called GFP instead of the EPG.

Remote wireless magnetic stimulation of EPG-expressing rats induced large muscle responses compared with control rats.

“We’ve found a noninvasive way to activate this gene once injected in the brain cells of mice and regulate movement in their limbs,” Galit Pelled, PhD, a medical bioengineering professor at MSU’s Institute for Quantitative Health Science and Engineering and the study’s lead author, said in a press release.

These findings suggest that the same strategy “could work similarly in humans,” he said.

In the future, a Parkinson’s disease patient with tremors could receive an injection of the EPG gene in a specified brain region. A magnet that emits electromagnetic waves could then activate the gene to help control, or ideally stop, the tremors.

“Technology is getting better and better every year, so this magnet could be built into anything,” Pelled said.

Deep brain stimulation, an established treatment for advanced Parkinson’s patients, is a surgical procedure that involves implanting a neurostimulator in the brain, which sends electrical impulses to specific brain regions.

However, this technique is highly invasive involving drilling a hole in the skull for electrode implantation. This process can damage neurons and other cells and even increase the levels of inflammatory factors.

Engineering stem cells to express the EPG gene and introducing them into the brain of Parkinson’s patients is the goal of Assaf Gilad, PhD, the study’s co-author and a professor of biomedical engineering and radiology.

“Stem cells are very good carriers of genes so if someone has Parkinson’s, we can introduce these stem cells into the brain as a therapy,” he said. “This type of treatment could not only help the brain, but could work in other parts of the body too, like the heart, and help those with heart issues.”

Researchers are now trying to understand the underlying mechanisms that allow the EPG gene to respond to magnetic waves.

“The mechanism of the gene is still unknown,” Gilad said. “But once we understand how it really works, it could open the door to even more possibilities.”

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Research Into Non-invasive Deep Brain Stimulation Earns Grossman Prize for Neuromodulation

Nir Grossman and Science PINS Prize

The 2018 Science & PINS Prize for Neuromodulation was awarded to Nir Grossman, PhD, for his research to stimulate deep and specific regions of the brain without surgery as a treatment for Parkinson’s disease and other disorders.

Grossman, who is an assistant professor at Imperial College London and a fellow of the U.K. Dementia Research Institute, will receive $25,000 and his awarded essay “Modulation without surgical intervention” will be published in the journal Science.

“By pioneering new tools and principles, we hope to potentially thwart disease pathology via direct and non-invasive modulation of the underlying neural activity,” Grossman said in a press release.

Established in 2016, the Science & PINS Prize for Neuromodulation is a highly competitive annual prize that honors scientists for their important contributions to the neuromodulation field. To apply, researchers submit a 1,500-word essay in which they describe their contributions based on studies performed in the past three years.

Grossman will present his prize-winning research at a ceremony Sept. 8, during the 9th Annual Meeting of the Chinese Neuromodulation Society in Beijing, China.

Deep brain stimulation (DBS) has shown potential to treat Parkinson’s patients who fail to respond to first- and second-lines of treatment. However, this strategy requires surgery to implant a medical device called a neurostimulator in the brain to deliver electrical stimulus to the areas that control movement. Because it is an invasive technique, there is an increased risk of complications.

To overcome this limitation, Grossman and his colleagues at the Massachusetts Institute of Technology developed a non-invasive DMS strategy that requires only placing small electrodes on the scalp, rather than into the brain.

This new method, called temporal interference stimulation, applies multiple electric fields of different frequencies at once; when combined, it produces a single signal that can be targeted to specific deep brain regions.

“By themselves, the changing electrical currents are too rapid to recruit neural activity, but at the small regions where the currents intersect, the amplitude [or wave height], of their combined currents changes at a low frequency that is capable of stimulating neural activity,” Grossman said.

While other non-surgical brain stimulation methods are already being assessed in human clinical trials, Grossman’s approach has the advantage of stimulating only specific targeted neurons without affecting the activity of their neighbors or overlying regions.

The team has tested their new non-invasive DBS method in mice, as described in its prize-winning essay.

Temporal interference stimulation was safe with no signs of cell death, DNA damage, increased tissue temperature, or seizure risk. Using this approach researchers were able to precisely activate the regions of the motor cortex that control movement of mice whiskers and forepaws.

“This approach opens the door to regulating disordered brain activity in diverse regions of the brain,” said Pamela Hines, who is a senior editor at the journal Science. “Grossman’s innovative and noninvasive technology holds tremendous promise for treating brain disorders.”

Grossman and his team expect to continue working on the temporal interference stimulation method to better understand its underlying mechanisms, but also to further improve its potential to target smaller regions of the brain.

“We hope that the fact that TI stimulation uses well-known electrical fields and does not require chemical or genetic manipulation of the brain tissue will help speed up its clinical deployment, where it may benefit the large patient population in need of neural therapy, ” Grossman wrote.

The team now hopes to further develop its technique together with expert labs around the world, hopefully translating it into clinical research and eventually, new treatments.

“It is clear that this is only the beginning of a potential long journey that requires a close collaboration between the world’s best engineers and clinicians to succeed,” Grossman said.

Carnegie Mellon University neuroscientist Aryn Gittis, PhD, was named prize finalist for her discovery of new therapeutic targets for Parkinson’s disease with her essay “Probing new targets for movement disorders.”

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Feedback from Parkinson’s Patients Can Help Improve Trial Recruitment, Retention, Study Says

clinical trial feedback

Getting the perspective of Parkinson’s disease patients on their motivations and experiences participating in clinical trials can help increase recruitment and retention of future studies, a report suggests.

Although preventable, one of the most common reasons Phase 2 or 3 trials fail is because not enough patients participate. This could be due to inadequate recruitment or because patients drop out during the trial.

The report, “Recruitment and Retention in Clinical Trials of Deep Brain Stimulation in Early-Stage Parkinson’s Disease: Past Experiences and Future Considerations,” published in the Journal of Parkinson’s Diseaseevaluated patient responses after a pilot study on the safety and tolerability of subthalamic (STN) deep brain stimulation (DBS) for the treatment of early-stage Parkinson’s disease.

DBS is commonly used to treat patients with advanced Parkinson’s who no longer respond to available medications and are unable to adequately manage their symptoms.

The U.S. Food and Drug Administration also recently expanded the use of DBS — which requires surgery to implant a device to stimulate targeted regions of the brain — to patients with mid-stage disease who also respond poorly to standard medications.

Vanderbilt University in Nashville, Tennessee, completed a clinical trial (NCT00282152) that included 30 patients, ages 50 to 75, with early-stage Parkinson’s disease. The participants were randomized to receive either optimal drug therapy (ODT) or ODT plus STN-DBS and followed for two years.

At the end of this pilot study, participants were asked to complete a survey regarding their experiences participating in the trial. Their responses were compared with those from an independent survey that used Fox Insight, an online clinical study platform established by The Michael J. Fox Foundation for Parkinson’s Research, to survey early-stage Parkinson’s patients who were considering possibly participating in a trial for DBS.

The pilot trial was specifically designed to collect preliminary safety and tolerability data necessary to conduct an FDA-approved Phase 3 trial (IDE#G050016) to investigate the hypothesis that DBS in patients with early Parkinson’s can slow disease progression.

Importantly, patient experiences were expected to inform the feasibility of scaling up recruitment for the future trial.

Results revealed that the primary motivation for participating in a clinical trial was the desire to advance medical research, cited by 85% of trial respondents. This was followed by a desire for the best medical treatment, for 70%, and for 59%, a desire to learn more about Parkinson’s disease. Similarly, altruistic motivations were also seen in the Fox Insight survey.

The most frequently listed fear that could impact trial participation was surgery-related concerns, in 44% of participants. Although 37% of the pilot study participants did not report any burdens, the most common burdens associated with clinical trials were financial commitments such as time off work and traveling costs (30%), as well as some of the therapeutic interventions such as neuropsychological testing (26%), and the weeklong therapeutic washout periods — without medication (26%).

The pilot study implemented a rigorous informed consent progress aimed at educating potential participants on their role in the study. Most participants responded positively to this approach. Providing sufficient education at the start of the trial may decrease the drop-out rate. In fact, only 3% of participants did not complete the study. As a result, this approach of informed consent will be used in the upcoming Phase 3 trial, according to the authors.

Getting patient perspectives is a new strategy that could improve clinical trial recruitment and retention. Whereas most clinical trials were solely designed by physicians, now, as the authors suggest, by asking patients about their experiences and including their feedback in trial development, “the focus shifts away from the physician and toward the patient.”

“By understanding the motivations and barriers to trial participation of past and potential subjects, we attempt to predict feasibility of recruitment in the future pivotal trial,” the authors wrote. “The fundamental similarities of these two cohorts of patients with early-stage [Parkinson’s disease] suggest that the planned multicenter, pivotal trial will experience similarly successful recruitment and retention as the single-center pilot trial.”

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Study Outlines Risk Factors for Frequent Falls in Parkinson’s Patients

frequent falls risk

Motor fluctuations, treatment with antidepressants, disease severity, and deep brain stimulation (DBS) are among the risk factors that contribute to frequent falls in patients with Parkinson’s, a large-scale study reports.

According to researchers, identifying predictors that put Parkinson’s patients at the greatest risk for falls can aid in early intervention to prevent these occurrences.

The study, “What predicts falls in Parkinson disease?” appeared in the journal Neurology: Clinical Practice.

Parkinson’s patients may experience falls as a result of their motor symptoms, such as uncontrollable accelerations, impaired balance, and freezing of gait. Approximately 50 percent of these falls require medical care.

Although a history of falling is considered the major risk factor for future falls, research reported that even individuals without any previous occurrences had a considerable risk of future falls. Other risk factors include disease stage and duration, older age, absence of tremor at rest, severity of motor impairment, cognitive dysfunction, taking antidepressants, and DBS — a surgical procedure to treat motor symptoms in Parkinson’s.

Recent studies also pinpointed dopaminergic treatment — intended to restore the reduced level of the neurotransmitter dopamine in Parkinson’s patients — disease severity, and gait characteristics, as well as clinical tests, as predictors of falls among patients without any previous history.

Researchers in this study analyzed longitudinal data from the National Parkinson Foundation Quality Improvement Initiative (NPF-QII) registry (NCT01629043) to discover what factors set apart Parkinson’s patients who are most likely to become frequent fallers.

The study included 3,795 participants from 19 NPF Centers of Excellence. A total of 3,276 (86.3%) patients reported no or rare falls in the three months prior to the first visit, of which 382 (11.7%) became frequent fallers by the annual follow-up visit. This rate is similar to those reported in prior studies, the researchers noted.

Predictors of falls included motor fluctuations, treatment with levodopa and antidepressants, DBS, reduced health-related quality of life, less than 90% of Parkinson’s diagnostic certainty, female sex, and worse semantic fluency (part of verbal fluency).

Another risk factor for falls was being a stage 2 or 3 on the Hoehn and Yahr scale — which is used to describe the progression of Parkinson’s symptoms, where stage 2 refers to bilateral involvement without impaired balance, and 3 to mild to moderate bilateral disease with postural instability but physical independence.

Regarding the association with antidepressants, the investigators said that although they are a known risk factor for falls in older adults and could indicate a greater incidence of depression — also a risk factor — clinicians should consider nonpharmacological alternatives to treat depression in Parkinson’s patients at risk of falling.

Between visits, factors contributing to conversion to “frequent faller status” included the addition of amantadine for involuntary muscle movements, a referral to occupational therapy, diagnoses of cancer or osteoarthritis, newly implemented DBS, and an increased need for social and hospital services, including more emergency visits, which may indicate poorer global health, the researchers said.

As for the correlation between DBS and the risk of falling, according to the authors, this finding is in line with evidence showing that postural instability and falls may worsen within the first year after surgery.

“We have identified a number of associations between disease characteristics, treatments, and comorbidities and emergent falls in [Parkinson’s],” they wrote. “Such identifiers may help target patient subgroups for falls prevention intervention.”

However, the scientists cautioned that although the analysis provides associations between risk factors and falls in Parkinson’s patients, it does not prove causality.

The NPF-QII registry is still recruiting participants for an estimated total of 10,000. It aims to identify the best expert care practices for improved outcomes, including survival and quality of life. The study is being conducted across the U.S., Canada, and in the Netherlands and Israel. More details on locations and contacts can be found here.

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Deep Brain Stimulation Seen to Ease Tremors in Patients with Early-stage Disease in Pilot Study

DBS and tremors

Deep brain stimulation (DBS) was seen to slow the progression of “rest tremors”  in patients with early-stage Parkinson’s disease, a pilot study reports.

The study, “Effects of deep brain stimulation on rest tremor progression in early stage Parkinson disease,” was published in Neurology.

“The finding around tremor is truly exceptional,” David Charles, MD,  professor and vice-chair of neurology at Vanderbilt University, in Tennessee, and the study’s senior author, said in a university news article. “Why it is so remarkable is because there are no treatments for Parkinson’s that have been proven to slow the progression of any element of the disease.”

Vanderbilt has been approved to conduct a large-scale, Phase 3 clinical trial looking at the effectiveness of deep brain stimulation in early-stage patients by the U.S. Food and Drug Administration based on this pilot study. It plans to start enrolling about 280 such patients when it opens next year.

This study’s findings point to DBS easing tremors associated with periods of rest — tremors very common in Parkinson’s patients and particularly distressing at early disease stages — but was too small to measure effectiveness or benefit with any significance.

DBS is commonly used to treat patients with advanced Parkinson’s who no longer respond to available medications and are unable to adequately manage their symptoms. The FDA also recently expanded use of DBS — which requires surgery to implant a device to stimulate targeted regions of the brain — to patients with mid-stage disease who also respond poorly to standard medications.

The pilot trial (NCT00282152), which took place at Vanderbilt’s medical center, looked at whether DBS might be safe and tolerable for early-stage patients. It included 28 people, ages 50 to 75, who had been taking Parkinson’s medications for at least six months and up to four years. They had no history of dyskinesia (uncontrolled movement) and stable motor symptoms.

Patients were randomized to receive DBS plus Parkinson’s medication, or medication alone. At baseline (study start) and 6, 12, 18, and 24 months, all agreed to stop all Parkinson’s therapy for one week (medication and/or stimulation). This allowed researchers to evaluate symptom changes and progression.

Results found that patients on medication alone were seven times more likely to again develop rest tremor two years post-treatment, compared to those patients given both DBS and standard therapy.

Analysis also revealed that 86% of the medication-only group developed new motor symptoms in limbs that were initially unaffected. This occurred in 46% of patients in the DBS treatment group.

Seven DBS-treated patients did not develop rest tremors in previously unaffected limbs, and four of these patients showed a lack of tremors in an initially affected limb at the study’s.

“The field of DBS therapy for Parkinson’s disease is moving toward earlier stages of treatment,” Charles said.  The planned Phase 3 study will both  “ensure patient safety and provide the Parkinson’s community with the best possible medical evidence to guide treatment.”

This large-scale trial — expected to begin in 2019 — will likely take place at Vanderbilt’s Nashville campus and at other 17 medical centers across the United States, according to the article.

The post Deep Brain Stimulation Seen to Ease Tremors in Patients with Early-stage Disease in Pilot Study appeared first on Parkinson’s News Today.

Source: Parkinson's News Today