Studies Show 3 out of 4 Parkinson's Disease Patients Can Improve Walking and Quality of Life Within 2 Weeks

Studies Show 3 out of 4 Parkinson's Disease Patients Can Improve Walking and Quality of Life Within 2 Weeks

Newly released virtual reality gait training device shown to improve quality of life for Parkinson's disease and other movement disorders.

Haifa, Israel (PRWEB) April 13, 2009 -- Parkinson's disease patients are discovering first-hand that daily exercise with a new virtual reality device, the GaitAid, has a positive effect on their walking ability, minimizing balance problems and freezing, and improving quality of life. The GaitAid offers a drug free, non RX alternative with no side effects.


As soon as I tried it my mobility improved tremendously! For the first time in over a year I am already walking without a cane. I am so impressed and so grateful. I was dreading my planned trip out of the country until I received your glasses. I cannot wait to share the miracle with my friends who suffer from PD. Thank you!
Gait velocity and stride length were improved in PD patients after training with a visual-and-auditory virtual cueing system, with a marked residual effect. Devices utilizing closed-loop visual feedback system are desirable non-pharmacologic interventions to improve walking in PD.
Daniel Neal, a Parkinson's disease patient from Palm Springs, CA., commented after receiving his GaitAid, "As soon as I tried it my mobility improved tremendously! For the first time in over a year I am already walking without a cane. I am so impressed and so grateful. I was dreading my planned trip out of the country until I received your glasses. I cannot wait to share the miracle with my friends who suffer from PD. Thank you!"

Yoram Baram, a computer science professor and incumbent of the Roy Matas / Winnipeg Chair in Biomedical Engineering at the Technion, Israel Institute of Technology has collaborated with several neurologists specializing in treating Parkinson's disease, Multiple Sclerosis and other movement disorders, in developing and testing a new, non-invasive training device designed to proactively minimize freezing and balance problems during walking. The noticeable physical and mental improvement of patients participating in clinical studies led Baram to bring the GaitAid device to market as a FDA registered medical device and is offering the device for a no risk trial period on his company's website (www.medigait.com).


Alberto J. Espay, MD, from the Neuroscience Institute, Department of Neurology, Movement Disorders Center, University of Cincinnati, specializes in research and clinical treatment of movement disorders. After offering the GaitAid to a group of his Parkinson's disease patients to use at home, Dr. Espay states, "Gait velocity and stride length were improved in PD patients after training with a visual-and-auditory virtual cueing system, with a marked residual effect. Devices utilizing closed-loop visual feedback system are desirable non-pharmacologic interventions to improve walking in PD."


The easy to use device includes special glasses and earphones which provide sensory feedback in response to the patient's movements. A practice session involves walking with the device for up to twenty minutes with no special training needed. These practice sessions soon start to evoke a lasting improvement for most Parkinson's disease patients. The degree of improvement varies, some patients use the GaitAid only occasionally after a few months while others make a short session a part of their daily routine to keep their results.

Parkinson's disease remains a mystery of medical science. For reason's unknown, certain brain cells stop producing a substance called Dopamine, which affects an individual's movement, strength and balance. There is currently no cure, though stem cell research offers future promise.

Emerging scientific evidence confirms that movement lessens neurological deterioration that contributes to Parkinson's Disease progression.

The device is available for a no risk trial period of 60 days:

online www.medigait.com
email: support (at) medigait (dot) com
or by phone 888-777-9906.

Shedding some light on Parkinson's treatment

Shedding some light on Parkinson's treatment

EUREKALERT
Contact: Lisa Van Pay
lvanpay@nsf.gov
703-292-8796
National Science Foundation
Scientists use optical approach to study deep brain stimulation


A research team lead by Karl Deisseroth in the bioengineering department at Stanford University has developed a technique to systematically characterize disease circuits in the brain. By precisely controlling individual components of the circuit implicated in Parkinson's disease, the team has identified a specific group of cells as direct targets of deep brain stimulation (DBS), a Parkinson's treatment.

Termed optogenetics, the NSF-funded technology uses light-activated proteins, originally isolated from bacteria, in combination with genetic approaches to control specific parts of the brain. The technique is a vast improvement over previous methods because it allows researchers to precisely stimulate neurons and measure the effect of treatment simultaneously in animals with Parkinson's-like symptoms.

Published in the April 17 issue of Science, Deisseroth's team found they could reduce disease symptoms by preferentially activating neurons that link to the subthalamic nucleus region of the brain. First, these specific cells were treated in a way that made them sensitive to stimulation by blue light, then the team implanted an optical fiber in the brain.

When researchers rapidly flashed blue light inside the animals' brains the disease symptoms improved. In contrast, treating with slower flashes of light actually made the symptoms worse, and targeting other kinds of cells had no effect at all, indicating both proper cell type and stimulation frequency are crucial components of effective treatment. Flashing blue light on portions of the same neurons found closer to the outer surface of the brain had an effect similar to treatment deep within the brain, raising the possibility that researchers may be able to develop treatments that are less invasive than current options.

Approved as a medical treatment in 1997, DBS remains controversial because it doesn't work on all patients. Used to treat Parkinson's disease, depression and movement disorders, DBS involves surgical implantation of a brain pacemaker, which sends electrical impulses into the brain. In the past, researchers have been unable to understand the effective mechanism of DBS because the electrical signal emitted by DBS devices interferes with the ability to observe brain activity.

Explains Deisseroth, "The brain is an electrical device, but it is a very complicated device. Think of it as an orchestra without sections: all of the types of instruments, or cells, are mixed together. Treatments like DBS are unrefined, in that they stimulate all of the cells or instruments. The optogenetic approach allows us to control stimulation of specific cells in the brain on the appropriate timescale, much like a conductor directing specific sections of an orchestra at the appropriate time."

Production of new therapies is always a long-term goal, but for now Deisseroth and his group are focused on mapping disease circuits and understanding brain function. "We need to understand the players before we can develop effective treatment strategies," he stated.

Arrayit Corporation and The Parkinson's Institute Announce New Research Collaboration

Arrayit Corporation and The Parkinson's Institute Announce New Research Collaboration

ARYC 2.63, -0.37, -12.5%) , a proprietary life sciences technology leader, announces a new research collaboration with The Parkinson's Institute of Sunnyvale, California to discover biomarkers for Parkinson's disease. This unique study involves the prospective collection of samples from well-characterized Parkinson's patients combined with Arrayit's new H25K microarray technology. The first experiments have enabled rapid and efficient sample preparation of specimens from Parkinson's disease patients, an important step in the discovery of molecular markers for Parkinson's disease.
"This collaboration provides an important first step towards unraveling the mysteries of Parkinson's disease," stated Dr. Mark Schena, Ph.D., Arrayit President. "We look forward to working with The Parkinson's Institute to decipher the molecular basis of the disease," he continued. The Parkinson's Institute Assistant Professor Dr. Birgitt Schuele, M.D. added, "Parkinson's disease represents a serious and challenging medical condition. We are pleased to be deploying Arrayit technology to combat this illness."

About Arrayit Corporation
Arrayit Corporation, headquartered in Sunnyvale, California, leads and empowers the genetic, research, pharmaceutical, and diagnostic communities through the discovery, development and manufacture of proprietary life science technologies and consumables for disease prevention, treatment and cure. It now offers over 650 products to a customer base of more than 2,500 laboratories worldwide, including most every major university, pharmaceutical and biotech company, major agricultural and chemical company, government agency, national research foundation and many private sector enterprises. Please visit www.arrayit.com for more information.
About The Parkinson's Institute
The Parkinson's Institute and Clinical Center (PI) is America's only independent non-profit organization that provides basic and clinical research, clinical trials and a comprehensive movement disorder patient clinic for Parkinson's disease (PD) and related neurological movement disorders, all under one roof. Our mission is to find the causes, provide first class patient care and discover a cure. Our unique freestanding organization supports a strong collaboration of translational medicine designed to more directly connect research to patient care -- from the "bench to bedside." Please visit www.thepi.org for more information.
Safe Harbor Statement
Except for historical information contained herein, statements made in this release that would constitute forward-looking statements may involve certain risks and uncertainties. All forward-looking statements made in this release are based on currently available information and the Company assumes no responsibility to update any such forward-looking statement. The following factors, among others, may cause actual results to differ materially from the results suggested in the forward-looking statements. The factors include, but are not limited to, risks that may result from changes in the Company's business operations; our ability to keep pace with technological advances; significant competition in the biomedical business; our relationships with key suppliers and customers; quality and consumer acceptance of newly introduced products; market volatility; non-availability of product; excess inventory; price and product competition; new product introductions, the outcome of our legal disputes; the possibility that the review of our prior filings by the SEC may result in changes to our financial statements; and the possibility that stockholders or regulatory authorities may initiate proceedings against Arrayit and/or our officers and directors as a result of any restatements. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company's Form 10-K for the fiscal year ended December 31, 2007 and Form 10-Q/A for the fiscal first quarter ended March 31, 2008 and Form 10-Q for the fiscal second quarter ended June 30, 2008.

Parkinson's Stem Cell Implants Yield Nightmarish Side Effects

Parkinson's Stem Cell Implants Yield Nightmarish Side Effects

Gina Kolata/ NY Times
A study that attempted to treat Parkinson's disease by implanting cells from aborted fetuses into patients' brains not only failed to show an overall benefit but also revealed a disastrous side effect, scientists report.
In about 15% of patients, the cells apparently grew too well, churning out so much of a chemical that controls movement that the patients writhed and jerked uncontrollably. The researchers say there is no way to remove or deactivate the transplanted cells.
On their advice the six patients who enrolled in the study but who had not yet had the operation have decided to forego it.
The results, reported in the New England Journal of Medicine, are a severe blow to what had been considered a highly promising avenue of research for treating Parkinson's disease, Alzheimer's disease and other neurological ailments.
The study indicates that the simple solution of injecting fetal brain cells into a patient's brain may not be enough to treat complex diseases involving nerve cells and connections that are poorly understood.
Some say it is time to go back to the laboratory and to animals before doing any more operations on humans. The findings also may fuel the debate over whether it is appropriate to use fetal tissue from aborted fetuses to treat diseases.
Despite their disappointment, some researchers said they hoped that the results would not bring fetal cell research to a grinding halt. The research has been controversial because the fetal cells were obtained from abortion clinics.
"This is still our one great hope for a cure," said J. William Langston, who is scientific director and chief executive officer at The Parkinson's Institute in Sunnyvale, CA.
Parkinson's disease occurs when for unknown reasons, cells of the substantia nigra in the base of the brain die. The hope was that fetal substantia nigra cells might take over for them. But the study showed in older patients, the operation had no benefit and in some younger patients, the transplants brought on nightmarish effects.
Although the paper depicts the patients with side effect in impassive clinical terms, doctors who have seen them paint a much different picture. Paul. E. Greene, a neurologist at Columbia University's College of Physicians and Surgeons and a researcher in the study, said the uncontrollable movements some patients suffer are "absolutely devastating."
"They chew constantly, their fingers go up and down, their wrists flex and distend," he said. And the patients writhe and twist, jerk their heads, fling their arms about."It was tragic, catastrophic," Greene said. "It's a real nightmare. And we can't selectively turn it off."
One man was so badly affected that he could no longer eat and had to use a feeding tube, Greene said. In another, the condition came and went unpredictably throughout the day, and when it occurred, the man's speech was unintelligible.
For now, Greene said, his position is clear: "No more fetal transplants. We are absolutely and adamantly convinced that this should be considered for research only. And whether it should be research in people is an open question."
Gerard D. Fischbach, who was director of the National Institutes of Neurological Disorders and Stroke, which sponsored the study and is now dean of the faculty of medicine at Columbia University's College of Physicians and Surgeons said that while the operation had been promoted by some neurosurgeons as miraculous, this was the first time it was rigorously evaluated, using sham surgery as a comparison. Fischbach was the director of the institute only at the end of the study.
"Ad hoc reports of spectacular results can always occur," Fischbach said. "But if you do these studies systematically, this is the result you get."
In the study, researchers led by Curt R. Freed of the University of Colorado Health Sciences Center in Denver and Stanley Fahn of Columbia University's College of Physicians and Surgeons, recruited 40 patients, aged 34 to 75, who had Parkinson's disease for an average of 14 years. The patients were randomly assigned to have substantia nigra cells from four fetuses implanted in their brains or to have sham surgery for comparison.
The surgery took place in Colorado and the patients were evaluated in New York. The fetal cell surgery involved drilling four small holes in the patient's forehead and then inserting long needles through the holes into the brain and injecting the fetal cells. The sham surgery involved drilling the holes but not injecting needles into the brain.
The study's primary measure of success was whether the patients themselves noticed that they were better, as determined by a survey that they mailed in a year later but before they knew whether they had fetal cell implants or not. The study found no difference between the two groups - neither those who had the fetal cell operation nor those who had the sham surgery noticed an improvement in their symptoms.
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23andMe already testing for rare Parkinson's mutations?

23andMe already testing for rare Parkinson's mutations?

Posted on: March 23, 2009 9:15 AM, by Daniel MacArthur
This casual aside on a recent post on personal genomics company 23andMe's corporate blog caught my eye:

Mutations in several other genes have also been associated with Parkinson's disease, but these are extremely rare. Many have been found only in one or two families. While these mutations are so rare that they are not covered by 23andMe (to date we have found no customers with any of them), studying them could help scientists better understand the mechanisms of Parkinson's generally... [my emphasis]

In other words, the company already has probes on its custom chip targeting these variants, but it isn't yet reporting results back to customers.

Why isn't it reporting back? If you'd asked me a couple of months ago, I'd say the motivation was probably to avoid the regulatory hassles associated with testing overtly clinical markers - but the company's willingness to provide results for large-effect variants associated with breast cancer pretty much rules that out.

Instead, the most likely reason to hold back on giving results back to consumers is (perfectly reasonable) caution about the reliability of the test. Screening for extremely rare variants is tricky for two reasons: firstly, since there are very few individuals around who carry the mutation, obtaining positive controls is difficult; and secondly, screening accuracy needs to be extremely high to keep down the rate of false positives.

To illustrate that last point, let's say there was a genetic variant with a population frequency of just 0.1% (1 in every 1000 people carry it)*. Now, let's say you have a test with false positive and false negative rates of just 1 in every 1000 tests, and you run that test on one million people. Of the 1000 carriers in the population, the test will only miss one; but it will also give a positive result for 999 people who are non-carriers. In other words, even for this extremely accurate hypothetical test, only 50% of the people who test positive are actually carriers.

This means that testing for rare variants requires exceptionally high standards of accuracy, probably higher than could reasonably be expected from chip-based assays. Given the risks of reporting potentially unreliable results back to customers for serious risk variants it makes good sense for 23andMe to hold off until it has developed extra assays for quality control; and it's unlikely to do this until it has seen at least a few customers who actually do test positive for the variant in question.

As for obtaining samples from real carriers to enable the development of validation assays: what better way to do that than to recruit 10,000 customers suffering from Parkinson's? Targeted recruitment of customers with other diseases will no doubt follow.

It is now abundantly clear that 23andMe is intent on moving into the overtly clinical domain; Navigenics' purchase of its Affymetrix testing lab and deCODE's move into disease-specific genetic tests are other signs that this is a shift that will involve the entire personal genomics industry.

Personal genomics is getting serious.

Early Parkinson's Treatment With Rasagiline Safe, Well Tolerated, and Effective Versus Placebo

Early Parkinson's Treatment With Rasagiline Safe, Well Tolerated, and Effective Versus Placebo: Presented at ADPD

By Chris Berrie

PRAGUE, Czech Republic -- March 14, 2009 -- Rasagiline monotherapy is safe and well tolerated, with clinical benefits versus placebo in patients with early, previously untreated Parkinson's disease (PD), researchers noted here at the 9th International Conference on Alzheimer's and Parkinson's Diseases (ADPD).

Early initiation of treatment with rasagiline 1 mg/day also provided significant clinical benefits over later initiation.

A prospective, multicentre study entitled Attenuation of Disease Progression With Azilect Given Once-Daily (ADAGIO) was presented here on March 13 by principal investigator Olivier Rascol, MD, Toulouse University Hospital, Toulouse, France.

"A treatment that slows or halts the progression of disease is a key unmet need in Parkinson's disease," Dr. Rascol stated. He and his colleagues utilised a delayed-start design in their randomised, double-blind, placebo-controlled trial to allow separation of disease-modifying effects from symptomatic effects in the examination of patients with moderate to advanced PD taking rasagiline monotherapy and combination therapy with levodopa.

Patient diagnosis was for cardinal PD signs -- resting tremor, bradykinesia, and rigidity -- with inclusion requiring a disease duration of less than 18 months from diagnosis and investigator judgement of no requirement for additional anti-PD treatment in the following 9 months.

The 1,176 patients enrolled were 61.1% male, with mean baseline characteristics as follows: age, 62.2 years; PD duration, 4.5 months; total Unified PD Rating Scale (UPDRS) score, 20.4; motor-UPDRS score, 14.2; and modified Hoehn and Yahr score, 1.5.

The study followed 2 phases: a 36-week placebo-controlled phase 1, followed by a 36-week full active-treatment phase 2. Randomisation was to 4 groups -- 2 of placebo followed by rasagiline 1 or 2 mg/day for delayed-start treatment (n = 595) and 2 of rasagiline 1 mg/day (n = 288) or 2 mg/day (n = 293) for the full 72 weeks. There were no significant baseline differences across these groups.

With rasagiline 1 mg/day, the 3 specific primary efficacy endpoints were met:
A. The slope in weeks 12-36 of phase 1 was significantly superior with active treatment versus placebo (difference, -0.05; 95% confidence interval [CI], -0.08 to -0.01; P = .0133).
B. Results from the early-start group were significantly superior to those of the late-start group at week 72 (difference, -1.7; 95% CI, -3.15 to -0.21; P = .025).
C. The noninferiority of the slope of early versus late start was met (difference, 0.0; 90% CI, -0.04 to 0.04; P < .0001).

The rasagiline 2-mg/day treatment showed significant benefit in phase 1 versus placebo (P < .001), but did not show superiority versus the delayed start at the end of phase 2.

The secondary endpoint for changes in total UPDRS score from baseline to week 36 for each rasagiline group was met for rasagiline 1 and 2 mg/day, as adjusted effect sizes of -3.0 (95% CI, -3.9 to -2.2; P < .0001) and -3.2 (95% CI, -4.0 to -2.3; P < .0001) respectively.

Rasagiline monotherapy was deemed safe and well tolerated, with few treatment-related adverse events and few discontinuations (placebo, 2.9%; rasagiline 1 mg/day, 3.1%; rasagiline 2 mg/day, 3.8%).

The researchers concluded that this early treatment with rasagiline 1 mg/day is consistent with disease-modifying effects, noting, "ADAGIO also confirms the symptomatic efficacy of rasagiline monotherapy versus placebo in patients with early [Parkinson's] disease."

Funding for this study was provided by Teva Pharmaceutical Industries Ltd. and Teva Neuroscience, Inc.

[Presentation title: The ADAGIO Delayed-Start Study Demonstrates That Early Rasagiline Treatment Slows UPDRS Decline. Abstract P1-423]

Long Term Results Similar in Two Parkinson's Medications

By Will Dunham

WASHINGTON, March 9 (Reuters) - People with Parkinson's disease may worry over which of two kinds of medications to use when first starting treatment, but a study published on Monday indicates the results are similar either way.

Researchers compared disability levels and quality of life after six years for people who started out taking either the standard generic drug levodopa or privately held German drug maker Boehringer Ingelheim's Mirapex, also called pramipexole.

The two drugs are generally employed as the first line of treatment for Parkinson's disease. In different ways, they address the decline in production of the brain chemical dopamine that occurs with the disease.

Parkinson's undermines control over movements and speech. Patients can have stiffness or rigidity of the arms and legs, slowness or lack of movement, and walking difficulties, along with tremors in their hands, arms, legs, jaw or face.

Levodopa is seen as better to deal with mobility issues and tremors. But it can cause involuntary movements known as dyskinesia, and its effectiveness also may wear off over time.

Mirapex may be less effective at handling motor control symptoms and can cause sleepiness. But it is less likely to cause involuntary movements or lose effectiveness over time.

"Despite a little bit of variations in how people were doing in specific areas, in terms of overall quality of life and disability measurements, the two groups looked the same," University of Rochester Medical Center neurologist Dr. Kevin Biglan, one of the researchers, said in a telephone interview.

"Then it becomes more of an individual decision in terms of short-term issues and individual preferences about some of these complications, potentially," he said.

Mirapex is in a class of drugs called dopamine agonists that also includes GlaxoSmithKline's (GSK.L) (GSK.N) Requip, or ropinirole.

The researchers tracked 222 patients in the study published in the journal Archives of Neurology.

Of those who started on Mirapex, 90 percent of them ended up also taking levodopa, a drug that has been around for more than four decades, Biglan said. But the side effects differed depending on which drug they started on, he added.

"There's been all this research trying to address what's the better initial treatment strategy. And patients have struggled with whether they were making the right decision in terms of what treatment to go with initially," Biglan said.

"So they could probably make a decision regarding either treatment without being overly worried about the long-term implications," he added. Boehringer funded the study. (Editing by Julie Steenhuysen)