Neuromodulation. 2015 Jun 5. doi: 10.1111/ner.12315.
OBJECTIVES:
MATERIALS AND METHODS:
RESULTS:
DISCUSSION AND CONCLUSION:
© 2015 International Neuromodulation Society.
Saturday, June 6, 2015
Beneficial Therapeutic Effects of Spinal Cord Stimulation in Advanced Cases of Parkinson's Disease With Intractable Chronic Pain: A Case Series.
The Emotional Impact of Parkinson’s Disease
A great deal of literature has been written about the physical impact of Parkinson’s disease (PD), but little information addresses the significant emotional impact of the disease. Many patients with PD experience behavioral health symptoms including depression, anxiety, hallucinations and insomnia. Problems with sleep, mood and slowed thinking are also common. Patients with PD often have challenges with falling and getting adequate sleep which may be related to anxiety, depression or physical restlessness. In addition, challenges with sleep often occur because the individual has difficulty turning over or changing position in bed.
Depression is quite common in patients with Parkinson’s disease. It may be caused by chemical changes in the brain as well as by a reaction to having a progressive and at times, debilitating disease. The individual is coping with the gradual loss of abilities that accompanies the progression of Parkinson’s disease. Depression can also contribute to poor concentration and confusion. Parkinson’s often slows the patient’s thought process affecting their ability to communicate ideas and feelings. As many as one third of people with Parkinson’s disease develop more permanent confusion related to dementia.
A patient with PD struggles with the gradual loss of independence. As the person becomes more reliant on their spouse or partner, children and other caregivers for help and these feelings of dependence are often demonstrated through mood irritability, frustration or sadness. Often the PD patient feels guilty about how their illness impacts the other important people in their lives.
The Parkinson’s decline often includes symptoms of apathy. Family and friends may interpret this to mean that the person with PD does not care about things or seems indifferent. The apathy or indifference is often more difficult to treat and may remain even with pharmacological intervention. As the disease advances, often symptoms of lethargy and fatigue also occur.
As the disease progresses, the patient may slowly become more dependent, fearful, indecisive and passive. They may talk less often, withdraw from family and friends and become less active even when encouraged to move about. They may feel lonely as they isolate themselves and as friends become more distant.
We have begun to understand that Parkinson’s disease has a significant emotional impact on the patient with the disease, but it also greatly affects the family. Often the impact of the disease creates substantial stress between the primary caregiver and the PD patient. Regularly, the primary caregiver reports feeling the PD patient isn’t trying hard enough to fight the physiological symptoms.
How can the patient with PD and their family better manage the emotional effects of Parkinson’s disease? The person with PD will often have success with antidepressant medication intervention. More often than not, adding in addition counseling and support groups are relatively helpful for both the patient with PD and the spouse or family member. At times, individual therapy feels most comfortable initially. Bringing the couple or family together later in the process can help open the lines of communication and allow everyone affected to begin to understand each person’s needs and feelings in order to reduce mounting anger and frustration.
There are also a few impressions that can help the family better understand the emotional effects of the disease. Often the PD patient will want to please the spouse and try harder. In addition, the patient may agree to make changes but then forgets due to thought slowing and short-term memory loss. The family and caregivers need to recognize that the PD patient’s apathy and slowed thought processes may interfere with their ability to take action and effectively make long term changes in their behavior.
Dr. Joseph Friedman wrote in his book, Brain and Behavior: Coping with Parkinson’s Disease, that at least half of PD patients report fatigue as their biggest problem. The challenge is that fatigue is often hard to measure, develops over time and can be difficult to treat. Nonetheless, it involves the caregiver intervening and urging exercise as well as working with their doctor to prescribe medication to help with sleep. He describes that many people lose motivation to perform routine tasks and their interest in things they enjoy and the people around them may wane. Often anhedonia occurs as interest may decrease in previously enjoyed hobbies.
D r. Friedman explains the apathy challenge. Apathy in PD can negatively affect the person’s motivation. On the other hand, it is often it is more apparent and more distressing to the spouse, care partner and family. Some argue that it is protective to the patient as it functions in place of sadness, worry and distress.
The caregiver and family are significantly emotionally impacted by the disease, yet a critical piece often overlooked. Caregivers struggle with frustration, social isolation and depression. They can benefit from encouragement to attend support groups, taking respite and care breaks and seeking therapy for themselves. Addressing both the Parkinson’s patient as well as the family is vital to family wellness and emotional health.
Parkinson’s disease is an intense disease, requires a great deal of energy, and can greatly increase one’s stress level. Both the patient with Parkinson’s as well as their family members will more effectively manage the disease when we recognize their individual and collective needs for extra support.
Lori N. Waldberg, LCSW
Behavioral Health Specialists at
Banner Sun Health Research Institute
bhspecialists@aol.com
602-570-6788
Lori Waldberg is a Licensed Clinical Social Worker who has spent more than eighteen years specializing in working with adult and senior clients experiencing emotional, cognitive, behavioral and substance abuse problems. Lori is a well-known speaker who provides training and education to professionals and caregivers on topics relating to memory changes, mental health, movement disorders and behavioral issues in adults and families. Lori provides behavioral health and dementia care consultation for hospitals, outpatient programs and agencies, home care and long-term care providers. Lori offers a private practice providing supportive therapy and behavior management for individuals and families coping with loss, mental health, cognitive and physical disorders out of Banner Sun Health Research Institute in the West valley and In-home therapy in Northeast Phoenix and Scottsdale
Friday, June 5, 2015
How Michael J. Fox Used Smarts, Celebrity And Philanthropy To Build His Parkinson's Foundation
Actor and Parkinson’s disease activist Michael J. Fox told a group of billionaires and philanthropists at the Forbes 400 Summit for Philanthropy on Wednesday about the challenges and successes he has experienced building his foundation for Parkinson’s research after having been diagnosed with the disease 15 years ago.
Fox recalled first being confronted with Parkinson’s symptoms while filming Doc Hollywood. He woke up one morning with a headache and noticed his pinkie finger was twitching. Fox was diagnosed at age 29.
“It took me three years to build a relationship with my neurologist and realize what I was dealing with,” said Fox. “Seven years out I could no longer hide the symptoms.”
That was when Fox decided to go public with his diagnosis. It was also when he realized that he could transform his story about a celebrity with a disease into a story about Parkinson’s. “The fact that this disease became a conversation was energizing,” said Fox. “I realized I had a chance to do something, so I started a foundation.”
Fox said his first step was to find someone who was intuitive, responsive and business-savvy to be his cofounder. Deborah Brooks, who started her career at Goldman Sachs before switching into the nonprofit sector, fit the bill.
Within eight weeks of starting the foundation Brooks said the foundation wanted to fund a biotech company and were told that this “isn’t done.” She said they quickly learned that every assumption in the nonprofit world had to be challenged, including requiring that researchers share their data — something that wasn’t routinely done. And they have gone on to fund specific research at a number of biotech companies. They also realized that while doctors and researchers meant well, the patient’s voice was often missing from the dialogue around the disease.
The Michael J. Fox Foundation for Parkinson’s Research, which was founded in 2000, spends nearly all the money it raises each year and therefore doesn’t have an endowment. This year the foundation is putting an impressive $70 million to work. Brooks said it had 66,000 donors in 2014 with a median gift of $50 and 68 people gave six to seven-figure gifts, among them billionaire and Google co-founder Sergei Brin, who has been a supporter for nine years and who knows that he is at risk of developing a hereditary form of Parkinson’s Disease, so is extremely interested in developing drugs that could stop the disease in its tracks. The foundation has funded biotech companies and university researchers in 25 countries, although two-thirds of their funding has been granted within the United States.
The number of donations has doubled in the last five years, said Brooks, in part because 85% of those donors have a personal connection with Parkinson’s. As the foundation has grown, it has also found ways to expand its reach both through research and drug development, which has led to collaboration with research focusing on other diseases, such as Alzheimer’s.
While Fox’s celebrity has been an asset in drawing attention to the disease and helping Parkinson’s patients feel optimistic and hopeful, Brooks says it also presents a challenge because the foundation sometimes has to earn credibility and prove that it isn’t “just another celebrity charity.” Perhaps for this reason, the foundation’s current CEO Todd Sherer is a scientist and there are several other scientists on staff.
“I saw the foundation as an opportunity for me as a patient to drive the agenda,” said Fox. “It’s hard to think of it as revolutionary, it just makes sense.”
http://health.einnews.com/article_detail/269260558/jEk2Gq7J5FC3yZQa?n=2&code=ga_qGBxHZ2aVYO4P
AMARANTUS OPENS FIRST CLINICAL TRIAL SITE AND COMMENCES PATIENT ENROLLMENT FOR LEAD PRODUCT CANDIDATE ELTOPRAZINE'S PHASE 2B STUDY IN PARKINSON'S DISEASE LEVODOPA-INDUCED DYSKINESI
- Study Commenced at the Parkinson's Disease and Movement Disorders Center of Boca Raton, a Nationally Recognized Leading Clinical Research Institution -
/EIN News/ -- SAN FRANCISCO and GENEVA, June 5, 2015 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing diagnostics in neurology, and therapeutic products in the areas of neurology, psychiatry, ophthalmology and orphan diseases, announced that the first clinical trial site is now open for enrollment for the Phase 2b study of its lead product candidate eltoprazine for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).
The study will commence at the Parkinson's Disease and Movement Disorders Center of Boca Raton, a nationally recognized leading clinical research institution renowned for its testing of new treatments for improving the symptoms of Parkinson's disease (PD) and decelerating its progression. Stuart H. Isaacson, M.D., Director of the Parkinson's Disease and Movement Disorders Center of Boca Raton, will serve as Principal Investigator.
"We are pleased that the first Parkinson's disease center of excellence is now available for enrollment in our PD-LID clinical study with eltoprazine," said Gerald E. Commissiong, President & CEO of Amarantus BioScience Holdings, Inc. "Advancing eltoprazine in this Phase 2 program represents an important milestone for the Company and a critical step in building momentum with our therapeutic pipeline where we expect to make significant progress over the course of 2015."
Parkinson's disease levodopa-induced dyskinesia (PD-LID) is an abnormal involuntary, movement disorder resulting from prolonged levodopa-based therapy, the most commonly prescribed treatment for Parkinson's disease. PD-LID occurs in approximately 60-80% of PD patients and is one of the most difficult problems facing people with the disease. This dyskinesia can be severely disabling and impact quality of life by prohibiting the ability to perform routine daily functions.
"I look forward to commencing dosing in this important Phase 2b trial, especially given the data from the earlier eltoprazine Phase 2a study demonstrating such encouraging tolerability and significantly reduced peak dose dyskinesia," commented Dr. Isaacson. "I believe eltoprazine has tremendous potential as a meaningful therapy to address a significant unmet need and improve the quality of life for individuals with Parkinson's disease."
The multi-center, 60-subject Phase 2b study in individuals with Parkinson's disease is a double-blind, placebo-controlled, four-way crossover, dose range finding, clinical trial designed to evaluate dose response effect of repeated eltoprazine dosing on safety, tolerability and dyskinesia severity using state-of-the-art rating scales, diaries and motion sensors (ClinicalTrials.gov Identifier: NCT02439125). Pharmacokinetics and pharmacodynamics will also be evaluated. The Company anticipates that results from the study will be available in 2016.
Additional study sites throughout the United States and Europe will be forthcoming for the Phase 2b clinical study with eltoprazine for the treatment of PD-LID.
Parkinson's Disease and Movement Disorders Center of Boca Raton
The Parkinson's Disease and Movement Disorders Center of Boca Raton is a nationally recognized leading clinical research institution that brings community access to Phase 2 and Phase 3 FDA-regulated clinical research trials testing new treatments for improving the symptoms of Parkinson's disease and trying to slow its progression. This Clinical Research Center is directed by Dr. Stuart Isaacson with experienced and compassionate research coordinators, and has conducted clinical research programs that have been sponsored by the Parkinson Study Group, the National Institutes of Health, the Michael J. Fox Foundation for Parkinson's Research, and numerous pharmaceutical companies. Over the past decade, research programs have led to the approval of several new medications for the progression of the disease. Ongoing studies have the potential for providing new hope for patients not responding well to current therapies. The Clinical research programs, and their commitment to helping find better treatments to not only improve symptoms, but also to ultimately slow, stop, or reverse the progression of the disease.
About Eltoprazine
Eltoprazine is a small molecule 5HT1A/1B partial agonist in clinical development for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID), adult attention deficit hyperactivity disorder (ADHD) and Alzheimer's aggression. Eltoprazine has been evaluated in over 680 human subjects to date, and has a well-established safety profile. Eltoprazine was originally developed by Solvay Pharmaceuticals for the treatment of aggression. Upon Solvay's merger with Abbott Pharmaceuticals, the eltoprazine program was out-licensed to PsychoGenics. PsychoGenics licensed eltoprazine to Amarantus following successful proof-of-concept trials in PD-LID and adult ADHD.
About Parkinson's Disease and Levodopa-Induced Dyskinesia (PD-LID)
Parkinson's disease (PD) is a chronic, progressive neurodegenerative disorder that causes motor symptoms such as tremors, rigidity and slowed movements as well as non-motor symptoms including cognitive impairment, mood disorders and autonomic dysfunction. The Parkinson's Disease Foundation estimates that there are approximately one million people living with Parkinson's disease in the United States and seven to 10 million PD patients worldwide. The most commonly prescribed treatments for Parkinson's disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. As dopamine neurons in the brain are lost the therapeutic efficacy of levodopa attenuates, and increased use is associated with a side effect of dyskinesias. These are involuntary, uncontrollable and often exaggerated and jerky movements. They are distinct from the static, rhythmic tremor as a symptom of Parkinson's disease. Levodopa-induced dyskinesia can be severely disabling, rendering patients unable to perform routine daily tasks.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) is a biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, psychiatry, ophthalmology and regenerative medicine. AMBS' Therapeutics division has development rights to eltoprazine, a Phase 2b ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, adult ADHD and Alzheimer's aggression, and owns the intellectual property rights to a therapeutic protein known as mesencephalic-astrocyte-derived neurotrophic factor (MANF) and is developing MANF-based products as treatments for brain and ophthalmic disorders. AMBS' Diagnostics division owns the rights to MSPrecise®, a proprietary next-generation DNA sequencing (NGS) assay for the identification of patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation, has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Test®) for Alzheimer's disease, which was developed by Prof. Thomas Arendt, Ph.D., from the University of Leipzig, and owns intellectual property for the diagnosis of Parkinson's disease (NuroPro). AMBS also owns the discovery of neurotrophic factors (PhenoGuard™) that led to MANF's discovery.
For further information please visit www.Amarantus.com, or connect with the Company on Facebook, LinkedIn, Twitter and Google+.
Forward-Looking Statements
Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are forward-looking statements. These forward-looking statements generally are identified by the words "believes," "project," "expects," "anticipates," "estimates," "intends," "strategy," "plan," "may," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements.
http://health.einnews.com/pr_news/269246208/amarantus-opens-first-clinical-trial-site-and-commences-patient-enrollment-for-lead-product-candidate-eltoprazine-s-phase-2b-study-in-parkinson-s?n=2&code=ga_qGBxHZ2aVYO4P
CONTACT: Investor and Media Contact:
Jenene Thomas
Jenene Thomas Communications, LLC
Investor Relations and Corporate Communications Ad
T: (US) 908.938.1475
E: jenene@jenenethomascommunications.com
Gender influences nonmotor symptoms in early Parkinson’s
By Eleanor McDermid, Senior medwireNews Reporter
The predominant nonmotor symptoms (NMS) in patients with Parkinson’s disease (PD) vary between men and women, shows an analysis of the Parkinson’s Progression Markers Initiative (PPMI) study.
Men with newly diagnosed PD had more impaired olfaction than women, but were less affected by anxiety. Women, however, had overall less cognitive impairment at diagnosis, despite both genders having had PD symptoms for 18 to 20 months at study enrolment.
Of note, most of the gender differences among the patients were enlargements of differences found between the 121 healthy male and 67 healthy female controls in the study, “suggesting these are likely intrinsic sex differences that may be further exacerbated by the onset of PD”, write the researchers in Neurology.
Among the PD patients, trait anxiety was significantly higher among the 145 women than the 269 men. Global cognition was significantly better among women than men, but while women had significantly better memory function, they had significantly poorer visuospatial ability.
Men had significantly worse olfactory function than women, at a median of 21.5 versus 24.0 points on the University of Pennsylvania Smell Identification Test.
Nevertheless, impaired olfaction was the strongest predictor of PD for both genders, report Rui Liu (National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA) and study co-authors.
Global cognition also predicted PD among both women and men, while autonomic dysfunction predicted PD among men only and sleep behaviour disorder among women only. These NMS distinguished between PD patients and controls with greater than 90% accuracy.
Editorialists Marina Picillo (University of Salerno, Italy) and Alfonso Fasano (University of Toronto, Ontario, Canada) note that “future strategies aimed at identifying patients with PD in their premotor phase should take potential sex differences into account in order to increase sensitivity.”
They add: “Since diagnosing PD at prodromal stages is our next challenging mission, one of the PPMI study purposes is to find reliable and widely applicable diagnostic biomarkers. In this context, Liu et al. remind us that sex matters, even in PD.”
medwireNews is an independent medical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2015
Licensed from medwireNews with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.
http://www.news-medical.net/news/20150604/Gender-influences-nonmotor-symptoms-in-early-Parkinsone28099s.aspx
Thursday, June 4, 2015
In the blink of an eye, VCU researchers detect early signs of movement disorders
Tuesday, June 2, 2015
Even if you don’t know what Parkinson’s disease is, you can likely recall the image of Muhammad Ali’s trembling hands, halting speech and mask-like expression — common symptoms of a chronic and progressive movement disorder that affects as many as 1 million individuals in the United States alone.
Despite decades of intensive study, the causes of Parkinson’s remain unknown, and a cure is still elusive. What’s more, there is no standard diagnostic test for the disease.
Researchers at Virginia Commonwealth University are working hard to change this.
For the past 12 years, Mark Baron, M.D., professor of neurology and interim director of the VCU Parkinson’s and Movement Disorders Center, and Paul Wetzel, Ph.D., associate professor of biomedical engineering in the VCU School of Engineering, have collaborated on the development of an automated eye-tracking system that detects and analyzes eye movements as a means to accurately differentiate and diagnose more than 20 neurological diseases. Notably, these include essential tremor — often confused with Parkinson’s but eight times more common — and vascular Parkinsonism — one of several syndromes that mimic Parkinson’s.
Since 2008, Baron and Wetzel have been assisted by George Gitchel, a Ph.D. candidate in biomedical engineering at VCU and a health science research specialist at the Southeast/Richmond Veteran’s Affairs Parkinson’s Disease Research, Education and Clinical Center at the Hunter Holmes McGuire VA Medical Center, where Baron is deputy director. The Richmond PADRECC is one of six specialized centers created by the Department of Veterans Affairs in 2001 to serve the estimated 80,000 veterans affected by Parkinson’s.
Movement disorders: The basics
While scientists continue to look for the causes of Parkinson’s disease, they do know that it involves the malfunction and death of vital nerve cells in the brain called neurons. Some of these dying neurons produce dopamine, a chemical that sends messages to the part of the brain that controls movement and coordination. As these cells die, and less and less dopamine is produced in the brain, the symptoms of Parkinson’s progress, leaving a person unable to control movement normally.
Until the development of the VCU researchers’ eye-tracking system, the only way to confidently diagnose Parkinson’s was to confirm clinical findings with the drug levodopa, which replaces the dopamine that someone with Parkinson’s has lost. If the patient responds dramatically to levodopa, they likely have the disease; if they don’t respond dramatically, they probably don’t have it.
However, this seemingly straightforward test comes with several pitfalls: Patients may falsely perceive a benefit when there is none, other disorders may respond superficially to levodopa, and side effects can hinder patients’ ability to perceive a benefit. Thus, the test is often not as simple as establishing a response or no response; instead, it may be limited to the vague impression of a patient or family member, and a true diagnosis may require many visits.
“If you take a population of movement disorder patients and follow them throughout their life, 65 percent will have their diagnosis changed at least once.”
General neurologists and movement disorder specialists are 50 and 80 percent accurate, respectively. But, “if you take a population of movement disorder patients and follow them throughout their life, 65 percent will have their diagnosis changed at least once,” Gitchel said. Because no accurate test exists for any neurological disorder, the misdiagnosis rate is huge.
The case of normal pressure hydrocephalus — an excessive accumulation of fluid in the brain whose symptoms mimic PD — is particularly striking: Perhaps 80 percent of brain surgeries for this disorder fail because they’re misdiagnosed.
This is what the eye-tracking system promises to improve upon. The key to understanding this technology is the eye, which functions as the proverbial canary in the coal mine, registering early the brain’s incremental loss of dopamine-producing cells, or indeed anything else that affects the brain. Before any other part of the body, the eyes reveal, albeit invisibly, a loss of control that produces a variety of characteristic movements, including ocular tremors, harbingers of the motor and nonmotorsymptoms that can take decades to manifest elsewhere.
How it all started
The effort to detect these characteristics began as an extension of the expertise Wetzel gained in the late 1980s and early 1990s while working to improve the ergonomics of Air Force cockpits. By tracking the eye movements of pilots, Wetzel could optimize the placement of the many cockpit instruments and controls; in collaboration with Baron, he applied the same technology to a different problem.
“It’s incredibly simple,” Gitchel said. Using infrared light, two head-mounted cameras follow the movement of a patient’s eyes as she attempts to fix her gaze on a screen-displayed object. While normal eye movements are highly regulated and follow well-defined patterns, neurological disorders alter eye movements in a fashion specific to the underlying condition.
In the early days after the creation of the Richmond PADRECC, Baron involved himself in too many projects. But once he realized the implications of his and Wetzel’s work on eye-movement tracking, he decided to devote more of his time and more of the center’s resources to this research and its clinical application. Most importantly, the hiring of Gitchel in 2008 allowed them to ramp up their effort.
Until then, Baron said, “We were dabbling all the way. Because [the project] became bigger and bigger, it was nice to finally have someone who was here full time. That’s where we were able to go from a snail’s pace to a blossoming to what it is today.”
Their research has consisted of two broad phases. Initially, for about two years, only patients with clinically confirmed disorders were tested, allowing the researchers to identify the patterns and parameters that describe particular diseases. Then, once they’d accumulated enough data, the team transitioned to seeing every new patient and comparing diagnoses made with and without the eye-tracking system.
Over the years, as they’ve refined the system, their accuracy has improved remarkably from 75-80 percent to nearly 100 percent today.
Before Gitchel’s arrival, Baron and his team had managed to test around 50 patients. Since then, they have looked at more than 3,000. These large numbers furnished data that made it “obvious that we could diagnose everything with incredible precision,” Baron said.
While the commercially available equipment is not particularly complicated, “the processing that goes on behind the scenes is,” Gitchel said. In addition to figuring out the signature patterns of each disorder, Wetzel and his collaborators have also written code that reads the cameras’ raw data, parses individual movements and calculates the parameters required for statistical analysis.
“Without a doubt,” Baron said, “this will be in everyone’s office at some point.”
Looking forward
With the hope of licensing their technology to a company, Baron and his collaborators agreed to partner with VCU Innovation Gateway in December 2012. Then, in August 2014, they filed for an international patent on the software they’ve developed. As Gitchel pointed out, “Anybody can buy the eye-tracking equipment off-the-shelf; it’s the research we’ve done over the years to figure what happens with an individual disorder, and the automated nature of our software, that’s what’s so valuable.”
In addition to being noninvasive and inexpensive, the researchers’ system is easy to implement, requiring minimal training time, minimal physician interaction and a mere five minutes to administer the test. What’s more, unlike the common electroencephalogram (EEG) or electromyography (EMG), the eye-tracking system produces data that do not need to be interpreted; when their current work is complete, the system will automatically generate a diagnosis.
So what needs to happen before this becomes widely used as a screening tool? Above all, the VCU researchers must overcome the skepticism of their professional peers, which Baron and Gitchel attribute to two main causes.
First, because the different eye rotations characteristic of neurological disorders are microscopic — about one quarter of a degree — and therefore cannot be detected without high-resolution cameras taking 500 photos per second, many doctors have never seen them and have difficulty accepting their existence.
Second, given the large number of publications by eminent eye researchers, many physicians wonder how the test for these disorders could be so simple, and why it wasn’t already figured out.
Gitchel meets this skepticism with a simple observation: “People have looked at eye movements for a hundred years. … And it’s always been, ‘Oh, look at this [strange eye movement]. Isn’t that interesting?’ But it was never [investigated] in a clinical setting. … That’s one of the beauties of what we do here. I’m the first door on this hallway; every single patient who comes in, I see them first. That’s why we have huge numbers and have been able to get such useful data. We’ve brought the research out of the lab and into a patient’s normal clinical visit. This is true translational research.”
“We’ve brought the research out of the lab and into a patient’s normal clinical visit. This is true translational research.”
Gitchel asserts that the use of this system brings an extraordinary degree of objectivity to a practice that is notoriously subjective and vague. Instead of the typical clinical exam, which combines family history with a patient’s performance on tasks such as stomping one’s foot and walking down a hall, their eye-tracking system “generates a massive amount of data very quickly” and creates “a way to purely quantify a disease,” Gitchel said.
Particularly remarkable is the system’s ability to diagnose drug-induced symptoms and combinations of disorders in the same patient, feats that are clinically difficult, and often impossible.
“The people who see [our system] in real time get it immediately,” Gitchel said. “I can sit down and explain all of it to you in 20 minutes. … [But] I can’t have a 20-minute conversation with every physician in the country. If someone big enough sees it and tells other people about it, then it’s going to start to get traction.”
Baron and Gitchel agreed that this someone would likely be a company that can shepherd their eye-tracking system through the arduous FDA-approval process.
Noting the huge profit potential of a device that could achieve ubiquity, Baron remarked, “We need a Shark Tank kind of person who says, ‘I’m going to make money,’ someone who’s going to make it happen.”
A neurosurgeon recently visited the Richmond PADRECC with a patient whose rare diagnosis had proved elusive. After Baron and Gitchel quickly and easily identified the condition using their system, the astounded physician said, “This is the greatest thing I’ve ever seen! Why doesn’t everyone have this?”
Feature image at top: George Gitchel, a Ph.D. candidate in biomedical engineering at VCU, models an automated eye-tracking system that detects and analyzes eye movements as a means to accurately differentiate and diagnose more than 20 neurological diseases.
From left to right, Paul Wetzel, Ph.D., associate professor of biomedical engineering in the VCU School of Engineering; George Gitchel, a Ph.D. candidate in biomedical engineering at VCU; and Mark Baron, M.D., professor of neurology and interim director of the VCU Parkinson’s and Movement Disorders Center. Since 2008, Gitchel has assisted Wetzel and Baron, who have collaborated on the tracking system’s development for 12 years.