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Initial Results Of PROGRESS Trial Show Promise For Abbott’s Infinity DBS System

DBS

Abbott has announced promising preliminary results from the PROGRESS trial (NCT02989610) evaluating its Infinity Deep Brain Stimulation (DBS) System for the treatment of Parkinson’s disease.

The initial results, detailed in a press release, suggest that the DBS system achieved its primary goal of broadening the “therapeutic window” — the range of stimulation that relieves symptoms without causing adverse effects.

Deep brain stimulation (DBS) is an invasive surgical technique in which thin wires are implanted in the brain to deliver electrical pulses to certain areas and ease motor symptoms in patients for whom standard medications are not effective.

Abbott’s DBS system differs from others in that it’s designed to “steer” electrical current toward specific parts of the brain in order to lessen symptoms such as tremors. This differs from traditional “omnidirectional” systems, which don’t target specific parts of the brain. Because the stimulation is more targeted, the theory is that patients should be able to get meaningful symptom relief with less stimulation. The preliminary results support this idea.

The system also uses a wireless Apple consumer device that allows doctors to perform upgrades and optimize programming settings without the need for surgery.

“We now have the first release of data to confirm the benefits of this technology over traditional omnidirectional lead technology in expanding the therapeutic window for a majority of patients,” said Matthew Brodsky, MD, medical director of the deep brain stimulation program at Oregon Health and Science University and the primary investigator of the PROGRESS trial.

The initial results included data for 66 Parkinson’s patients who were evaluated after three months of using the DBS system. The majority (89.4%) had a wider therapeutic window — an average increase of 35% — accompanied by an average decrease of 30% in the amount of stimulation needed to attain a therapeutic effect compared with patients who were using a conventional “omnidirectional” system.

“In the PROGRESS trial, patients were assessed sequentially, receiving conventional stimulation followed by directional stimulation,” said Keith Boettiger, vice president of neuromodulation at Abbott.

“Despite being blinded to their stimulation type, twice as many patients preferred directional stimulation. Clinicians also preferred directional stimulation in four times as many patients, demonstrating that the Infinity system with our directional lead technology can help people find symptom relief more easily than systems with conventional stimulation,” he said.

The PROGRESS trial is set to include up to 235 patients being treated for Parkinson’s disease with electrical stimulation at 37 sites across seven countries.

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Deep Brain Stimulation System Aimed at More Precise, Safer Targeting in Parkinson’s Patients

deep brain expectations, Versice

A tool called Vercise Cartesia Directional Lead is intended to provide more precise deep brain stimulation (DBS) treatment for people with Parkinson’s disease.

Researchers at UHealth — University of Miami Health System recently became the first in the Eastern U.S. and the second in the country to adopt the system.

DBS is a surgical approach used to treat Parkinson’s motor symptoms, normally in patients who no longer respond effectively to medications and show a reappearance or worsening of symptoms such as tremors and dyskinesia — involuntary, jerky movements.

In DBS, leads, or wires with electrodes at the tips, are implanted in selected regions of the brain. They are connected to a pacemaker-like neurostimulator to provide electrical impulses.

Vercise Cartesia Directional Lead, an implantable pulse generator manufactured by Boston Scientific, contains eight individually controlled electrodes on each lead for more precise control of the shape, range, position, and direction of electrical stimulation to the brain.

The device’s precise stimulation is also key for lessening side effects. The pulse generator has contoured edges designed to minimize erosion and increase patient comfort. It comes with a rechargeable system with a battery longevity of a minimum of 15 years. Compatible with the directional lead, the Vercise PC DBS System offers the same stimulation ability, with a projected battery duration of at least three years with standard settings.

“As technology advances, we are able to further fine tune and enhance DBS for people with Parkinson’s,” Corneliu Luca, MD, PhD, a professor of neurology and director of UHealth’s Deep Brain Stimulation Program, said in a press release.

Software called Neural Navigator 2 was designed for flexible programming, suitable for patients throughout their disease course. In addition, Clinical Effects Mapping software provides a summary of therapeutic benefits and side effects, while keeping track of the patient’s history on the pulse generator.

“Our mission is to offer Parkinson’s patients throughout Florida the latest treatment and most cutting-edge technology to improve their quality of life. It’s always exciting to add new therapies to our comprehensive treatment program.” said Jonathan R. Jagid, MD, a neurosurgeon at UHealth and an associate professor of neurological surgery who has performed more than 1,000 DBS surgeries.

Both Luca and Jagid have played a key role in clinical trials of this DBS system for approval by the U.S. Food and Drug Administration, as part of UHealth’s Center for Parkinson’s Disease and Movement Disorders. Europe and Australia have also already approved the system.

Two trials — one called INTREPID (NCT01839396) conducted in the U.S. and another called VANTAGE (NCT01221948), which took place in Europe — showed that the Vercise system improved movement control in most patients, while also being associated with better quality of life.

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Loud, Startling Sounds Can Decrease Parkinson’s Muscle Stiffness, Study Suggests

loud sounds, muscle stiffness

Loud and alarming sounds can reduce muscle stiffness in Parkinson’s disease patients treated with subthalamic nucleus deep brain stimulation (STN-DBS), a study suggests.

The study, “Influence of alarming auditory cues on viscoelastic stiffness of skeletal muscles in patients with Parkinson’s disease,” was published in Clinical Biomechanics.

Almost 100 years ago, a French neurologist described a phenomenon called paradoxical kinesis (meaning “difficult to understand movement”) consisting of a dramatic but temporary reversal of Parkinson’s motor symptoms in the face of startling situations such as an oncoming car or loud sounds.

“The phenomenon of [paradoxical kinesis] suggests the existence of neural systems that can override parkinsonian impairment in certain conditions,” the researchers wrote in this study.

The association between paradoxical kinesis and muscular rigidity has never been described, probably due to the subjective, observer-dependent scoring methodology while performing clinical assessments of “rigidity during the transitory motor alterations” and also due to the “subjective nature of the examinations according to the Unified Parkinson’s Disease Rating Scale (UPDRS),” according to the researchers.

Increased rigidity has been linked to more viscoelastic stiffness of skeletal muscles. Muscles behave like springs, and while something that is elastic immediately returns to its original shape once a stress has been removed, a tissue that is viscous will deform permanently. Therefore, viscoelasticity refers to the muscle having properties of both, allowing it to slowly recover from being stretched or deformed.

Measurement of muscle tone using a myotonometer — a device that measures viscoelastic characteristics of soft tissues — has proved useful in quantifying the effect of therapeutic interventions on rigidity in Parkinson’s patients.

“Thus, evaluation of viscoelastic stiffness could potentially enable quick and reliable measurements of muscular rigidity during the enhancement of motor performance due to external cues in patients with [Parkinson’s disease],” the researchers wrote.

The team from the University of Tartu in Estonia assessed the effect of alarming auditory signals on viscoelastic stiffness of skeletal muscles in patients treated with STN-DBS — a surgical treatment for Parkinson’s disease that involves implanting a device to stimulate targeted regions of the brain with electrical impulses generated by a battery-operated neurostimulator. Patients can use a handheld controller to turn the DBS system on and off.

The team recruited 10 advanced stage Parkinson’s disease patients (three women and seven men) who had been treated with STN-DBS for approximately 4.5 years prior to the study.

Eight subjects had akinetic-rigid (i.e., slowness of movement accompanied by muscle stiffness), and two had the tremor-dominant subtype of Parkinson’s disease. Ten age- and gender-matched healthy individuals were also recruited to use as controls.

Using a myotonometer, the investigators measured the viscoelastic stiffness of the participants’ wrist skeletal muscles, or in other words, the muscle’s resistance to the force that changes its shape, after one night of Parkinson’s medication withdrawal.

Wrist examinations were performed by two different examiners, 10 times each. Measurements were repeated and compared during the DBS-on and DBS-off periods, with and without auditory alarming signals.

Compared with the DBS-off period, muscular stiffness was significantly reduced in the DBS-on phase, supporting the the effectiveness of the stimulation treatment in lessening one of Parkinson’s motor features.

In addition, wrist stiffness was also significantly decreased during the DBS-off period in the presence of alarming auditory signals.

“The mean values of stiffness during the DBS-on phase were lower than during the DBS-off with [alarming auditory] signals phase but the difference was not significant,” the researchers wrote.

Exposure to loud sounds did not change muscle stiffness in the control sample, suggesting that the paradoxical kinesis phenomenon is more pronounced in Parkinson’s patients.

“According to our data, the changes in muscular rigidity due to [alarming auditory] signals are an exclusive characteristic of the patients with [Parkinson’s disease],” the researchers said.

Further larger-scale research is necessary to confirm this study’s findings and assess the efficacy of auditory cueing in Parkinson’s disease.

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New DBS Method Eases Both Cognitive and Motor Symptoms in Parkinson’s Patient, Study Shows

DBS patient expectations

A new approach to deep brain stimulation (DBS) was able to reduce both motor and cognitive impairments in a patient with Parkinson’s disease, a case study reports.

Described by the researchers in Spain who conducted the study, this alternative to conventional DBS involves a single electrode that is placed in each side of the brain, which is able to stimulate two different regions at the same time.

The study, “Simultaneous Stimulation of the Globus Pallidus Interna and the Nucleus Basalis of Meynert in the Parkinson-Dementia Syndrome,” was published in the journal Dementia and Geriatric Cognitive Disorders.

DBS is a type of surgery recommended for Parkinson’s patients who fail to respond to other medications. The procedure involves implanting a device that sends electrical signals produced by a battery to stimulate specific regions of the patient’s brain.

Although previous studies have shown that DBS can effectively reduce Parkinson’s motor symptoms, the same cannot be said regarding cognitive deficits, which may affect up to 60 percent of recently diagnosed patients.

“In fact, patients with dementia or significant cognitive impairment are often excluded from DBS studies … based on reports of irreversible cognitive worsening after DBS surgery in patients with preexisting cognitive impairment,” the researchers wrote.

Now, these researchers have explored the therapeutic potential of a new type of DBS that is able to target two brain regions simultaneously.

The single-case study focused on a 68-year-old patient with six years of clinical history, showing signs of mild cognitive impairment, who underwent DBS targeting two different regions of the brain with a single electrode placed on each hemisphere (half): the globus pallidus interna (GPi), to treat motor symptoms; and the nucleus basalis of Meynert (NBM), to treat cognitive deficits.

Two months after starting GPi stimulation, the patient started showing signs of motor improvement, reflected by a reduction of 61.37% in the Unified Parkinson’s Disease Rating Scale (UPDRS-III) score and in a performance improvement of 80% during the Up and Go test, compared with before the treatment. The UPDRS-III assesses the severity of motor symptoms, while the Up and Go test assesses mobility according to the time it takes an individual to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.

Moreover, the levodopa equivalent dose (a rough technique to compare different medications; LED) score decreased by 16.81% following GPi stimulation.

Motor improvement at two months was accompanied by a general decline in cognitive performance. However, minor cognitive improvements were found three months after the patient began receiving NBM stimulation together with GPi stimulation, namely in the capacity for abstraction, non-verbal memory (our visual memory system), verbal memory retrieval, and speed processing (the time it takes a person to do a mental task).

“The follow-up conducted 1 year after starting the combined GPi + NBM stimulation confirmed the improvement in UPDRS-III scores, along with a 20% reduction in LED compared to baseline. No visual side effects were recorded during the follow-up,” the researchers wrote.

“This approach showed no significant side effects and resulted in improvements in certain cognitive functions in a patient with baseline mild cognitive impairment, which would have excluded this patient from undergoing DBS under most current protocols. Further research is necessary before offering this surgical alternative to a wider range of patients,” they concluded.

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Clinical Improvements From DBS Mostly Meet Parkinson’s Patients’ Expectations, Study Shows

DBS patient expectations

Deep brain stimulation can effectively reduce physical impairment caused by Parkinson’s disease and meets most patients’ expectations for improvements in several domains, a study reports.

However, researchers found that the procedure did fall short of meeting most patients’ expectations concerning the reduction of non-motor symptoms.

The study, “Does the degree of improvement after deep brain stimulation surgery for Parkinson’s disease (PD) meet the patient’s expectations?” was presented at the recent 2018 International Congress of Parkinson’s Disease and Movement Disorders in Hong Kong.

Deep brain stimulation (DBS) is a technique that uses electric stimulus applied to specific areas of the brain to treat people with advanced Parkinson’s disease whose motor symptoms, such as tremors, are not reduced with standard medication.

Thin wires are surgically implanted in the brain to deliver electric pulses to the subthalamic nucleus (STN) or the globus pallidus interna (GPi), areas of the brain involved in motor function.

Several studies have shown that DBS can effectively reduce motor symptoms and the necessary daily dose of medication, improving overall quality of life, in patients with advanced Parkinson’s as well as in patients with early-stage disease.

In this exploratory study, researchers identified which symptoms patients expected to improve with DBS and whether the anticipated levels of improvement were met after they had the procedure.

The team assessed expectations prior to surgery and at six months to two years after DBS in 28 patients with advanced Parkinson’s disease, 20 of whom underwent STN-DBS and eight of whom had GPi-DBS. All patients completed a visual analogue scale (VAS) questionnaire — used to measure subjective characteristics or attitudes believed to range across a continuum of values and cannot easily be directly measured.

Significant clinical improvements regarding physical impairment, mobility, ability to perform activities of daily living, and stigma after DBS were observed. In addition, a significant reduction in total levodopa equivalent daily doses (mg/day) of 50.45% was observed in patients treated with STN-DBS.

These objectively determined outcome improvements were in accordance with patients’ self-reported changes after the treatment.

In general, pre-DBS patients’ expectations and the positive changes in Parkinson’s symptoms noted were not significantly different.

“There was no significant difference … between the pre-DBS expectations of general improvement in PD [Parkinson’s disease] symptoms and the perceived general improvement 6 months to 2 years after surgery confirming that general expectations of improvement were met after DBS,” the researchers wrote.

Most patients reported that expectations of improvement after DBS were met, namely 64% for motor symptoms, 71% for quality of life, and 83% for reductions in daily medication dose.

However, only 25% of the expected levels of improvement were met for non-motor symptoms and social domain.

The motivations for DBS were also met after surgery. In the GPi-DBS group, all patients (100%) were satisfied with the final reduction on uncontrolled movements (dyskinesia), 83.3% for motor symptoms, and 66.7% for quality of life.

In the STN-DBS treated group, 84.2% were satisfied with medication reduction, 78.9% with amelioration of motor symptoms, and 73.7% with their quality of life.

These findings demonstrate that DBS clinical outcomes meet the expectations of most patients. However, pre-DBS expectations for improvement of non-motor symptoms and social domain were not met after surgery.

“Overall, both STN-DBS and GPi-DBS patients were satisfied that DBS had met their expectations of surgery,” the researchers concluded.

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Study Reveals Mechanisms Underlying Pain Processing in Parkinson’s Disease

pain, subthalamic nucleus

A novel pain-sensing brain network links pain in Parkinson’s disease to a specific region of the brain, called the subthalamic nucleus, an animal study has found.

The findings illustrate why this specific brain region is a potential target for pain relief in Parkinson’s, as well as in Huntington’s disease, and other neurodegenerative disorders.

The study, “Revealing a novel nociceptive network that links the subthalamic nucleus to pain processing,” was published in the journal eLIFE.

Pain is one of Parkinson’s non-motor symptoms and may manifest as burning, stabbing, aching, itching or tingling sensations. Scientists believe that these symptoms, which are not directly related to the pain caused by the disorder’s motor symptoms, result from dysfunction of the central nervous system.

Deep brain stimulation (DBS) of the subthalamic nucleus (STN), a brain area involved in motor function that is hyperactive in Parkinson’s patients, is an effective technique to ease motor dysfunction. This surgical treatment also has been shown to weaken pain intensity, but the mechanism underlying this benefit remains unclear.

Early studies have indicated that the STN could be part of a network involved in pain perception, but little is known about the type of sensory stimulus activating this brain area.

“We set out to determine whether the [STN] is involved in translating a harmful stimulus such as injury into pain, and whether this information transmission is altered in [Parkinson’s],” Arnaud Pautrat, the study’s lead author, said in a press release.

The research team from France and the U.K. conducted electrophysiology (electrical activity) experiments in rats subjected to a shock to the hind paw. This showed that neurons in the STN could be separated into three groups, depending on whether their electrical activity increased, decreased or was unchanged upon being shocked. Most of the responsive cells changed their activity specifically after pain stimulation and not other types of stimuli.

Then, the team explored if damage to the STN changed these responses. Results showed that rats with lesions in this brain area took much longer to manifest discomfort in comparison to controls.

Subsequent experiments in a rat model of Parkinson’s revealed that neurons in the STN had higher firing rate (greater activity) and exhibited bigger and longer responses to pain than healthy animals. According to researchers, these findings suggest that Parkinson’s-associated pain is caused by impaired pain processing in this brain area.

To understand where pain signals in the STN could come from, the team focused on the superior colliculus and the parabrachial nucleus, two brain areas that relay damage signal originating from the spinal cord.

Blocking the activity or damaging these regions changed the number of STN cells responding to pain, revealing the key role of both regions. Also, researchers found that the parabrachial nucleus and the STN are directly connected.

“We have found evidence that the [STN] is functionally linked to a pain-processing network and that these responses are affected in Parkinsonism,” said Veronique Coizet, PhD, the study’s senior author. Of note, Parkinsonism is a general term for neurological disorders that cause movement problems similar to those of Parkinson’s patients.

Overall, the team believes this network is possibly implicated in the pain relief achieved with DBS in Parkinson’s patients. Coizet noted that more work is necessary to fully characterize the effects of DBS on the STN in animal models.

“The STN-DBS technique can thus be considered in the future as a new target for the treatment of pain in pharmaco-resistant patients suffering from previously described neurodegenerative disease, but also, for example, in chronic pain disease or pharmaco-resistant patients with certain form of migraine,” researchers wrote.

“Further experiments are now needed to fully characterize the effects deep brain stimulation on this brain region in our experimental models, with a view to finding ways to optimize it as a treatment for pain caused by Parkinson’s and other neurological diseases,” Coizet added.

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Deep Brain Stimulation May Increase Levels of Inflammatory Factors in Parkinson’s, Study Suggests

DBS in Parkinson's patients 

Deep brain stimulation (DBS) may increase the levels of hepcidin — a hormone associated with iron accumulation and inflammation in the brain — in Parkinson’s disease patients, according to a small Polish study.

The study, “Higher serum levels of pro-hepcidin in patients with Parkinson’s disease treated with deep brain stimulation,” was published in the journal Neuroscience Letters.

As people age, iron accumulates in several brain regions and cells, including the microglia (the immune cells of the brain) and the astrocytes (cells that regulate nerve cell communication and survival ).

Increased iron accumulation, as well as brain inflammation, is associated with oxidative stress and cellular damage and is observed in several neurodegenerative disorders such as Parkinson’s and Alzheimer’s disease.

Hepcidin, an iron balance-regulatory hormone, suppresses ferroportin (FPN1) — the protein that transports iron out of cells — and leads to cellular iron accumulation.

Because inflammation can induce the production of hepcidin, this hormone may be a link between brain inflammation and iron-induced oxidative damage, both of which are involved in neurodegeneration in Parkinson’s patients.

Researchers in Poland evaluated the levels of pro-hepcidin — the precursor of hepcidin — in Parkinson’s patients treated only with medication, in those who, in addition to medication, also received DBS, and in healthy people (controls).

DBS — high-frequency stimulation in strategic brain areas through surgically implanted thin wires in the brain — is a treatment strategy for people with advanced Parkinson’s disease whose motor problems do not improve with medication.

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

Blood samples were collected from 52 people with Parkinson’s disease (25 women and 27 men) with a mean age of 56, and 31 healthy individuals (15 women and 16 men) with no history of neurodegenerative disorders in the family and a mean age of 58.

Among Parkinson’s patients, 37 had been treated only with medication — levodopa (L-DOPA) and/or ropinirole (Requip) — and 15 with additional DBS (with a mean time from implantation of 28.4 months).

Parkinson’s patients had significantly higher levels of pro-hepcidin compared to healthy individuals, supporting the involvement of hepcidin in Parkinson’s disease.

Those treated with medication and deep brain stimulation showed the highest levels of pro-hepcidin. There was no association between hepcidin levels and the duration of DBS, patient’s age, duration of the disease, or medication dose.

Since DBS has been associated with the activation of microglia and astrocytes — which release inflammatory molecules — researchers hypothesized that the overproduction of pro-hepcidin in these patients may be related to DBS and its associated inflammation.

But considering the small group of patients treated with DBS, additional studies are needed to clarify this association and whether it affects the worsening of Parkinson’s disease.

“The results obtained should be interpreted very carefully but are an interesting observation that requires further research, including a larger group of patients,” the researchers wrote.

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Source: Parkinson's News Today

11 Facts About Parkinson’s Disease You May Not Know

Most people know of Parkinson’s disease and have a good idea of its symptoms, but very few know much more than that about this progressive illness. Since Parkinson’s disease awareness month is around the corner (April), we’ve put together some simple stats and facts that you can share near and far.

With help from the Parkinson’s Disease Foundation, everydayhealth.com, and ecaring.com, here are 11 facts about the disease most people don’t know. (Some of them may even surprise you!)

It’s a movement disorder. 
Parkinson’s disease is a neurodegenerative disease whereby cells responsible for producing dopamine die off in the substantia nigra area of the brain. Dopamine is essential for movement as it acts as a transmitter for signals from the brain to other parts of the body.

Who found it?
Parkinson’s disease was discovered by British surgeon Dr. James Parkinson in 1817.

How prevalent is it?
Approximately one million people have Parkinson’s disease in the U.S. and there are around 50,000 new cases diagnosed each year.

Most patients are middle-aged. 
The average age of someone diagnosed with Parkinson’s disease is 56. Around 4 percent of Parkinson’s patients are diagnosed before the age of 50.

MORE: What it’s like getting diagnosed with Parkinson’s disease at the age of 34

When is it considered young-onset Parkinson’s disease?
It’s considered young-onset if diagnosed before the age of 40. The youngest recorded case of Parkinson’s was a 12-year-old patient.

How is it diagnosed?
There is no blood test or scan that can diagnose Parkinson’s disease. Doctors look for four classic symptoms of the disease before reaching a diagnosis: tremors, rigidity in the wrist and elbow joints, lack or slowness of movement, and an unstable posture.

It affects mostly men. 
Parkinson’s disease is twice as likely to affect men than women.

There’s no known cause. 
There is no known cause of Parkinson’s disease although a family history of the disease will increase your risk. Researchers think environmental factors such as smoking, pollution, heavy metals, medications and illegal drugs may be responsible for the onset of the disease. Head trauma, brain inflammation, and stroke have also been associated with the disease.

MORE: Four possible causes of Parkinson’s disease

Parkinson’s is expensive. 
Treating patients with Parkinson’s disease costs the U.S. around $25 billion a year. The average patient will need $2,500 worth of medication each year and therapeutic surgery could cost up to $100,000.

How do you treat it? 
There is no cure for Parkinson’s disease but there are medications that can help patients with the symptoms. Patients can also undergo deep brain stimulation where electrical current is used to help block tremors and other movement symptoms of the disease.

There’s a correlation between Parkinson’s and depression. 
Dopamine is also associated with mood as well as movement. It’s estimated that more than half of Parkinson’s disease patients suffer from depression and around 40 percent suffer from anxiety.

MORE: Treating depression and anxiety in Parkinson’s disease patients

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.

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