The Motor Network In Parkinson’s Disease And Dystonia: Mechanisms Of Therapy
open to eligible people ages 21-75
This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson’s disease and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson’s disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S. This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus , ten PD patients with a globus pallidus target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.
San Francisco, California
How Do Trials Help Scientists And Healthcare Professionals To Understand Parkinsons Disease
Stott: Clinical trials allow us to build up information about the natural history of the condition the lived experience in a manner that can be quantifiably measured. Over time these methods of measuring Parkinsons are improving and evolving. We have moved beyond simple questionnaires and clinical rating scales towards brain imaging techniques, biological sample, and artificial intelligence approaches. We are collecting more and more data from non-clinical settings using digital and wearable technology, providing a richer definition of Parkinsons.
Matthews: We are also collecting data on preclinical trials to help us identify and pre-screen potential participants for clinical trials of specific sorts of Parkinsons. One example of this is PD Frontline, a UK based study, which aims to identify a cohort of people with a genetic form of Parkinsons.
How Might Clinical Trials Help In Parkinsons
Clinical trials can help people with Parkinsons in many ways. Some of the benefits include:
- broadening our understanding of Parkinsons so that existing treatments can become more effective
- giving people with Parkinsons the opportunity to be involved in research which uses the most up-to-date treatments and devices
- helping to improve the quality of life for people with Parkinsons
- improving treatment for future generations of people with Parkinsons
- leading us closer to a cure.
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Dual Frequency Stimulation In Parkinson’s Disease
Sorry, not yet accepting patients
Deep brain stimulation in the dorsal region of the subthalamic nucleus is very effective for reducing motor symptoms of Parkinson’s disease . Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation of the ventral STN alongside standard high frequency stimulation of the dorsal STN in patients with PD.
at UC Davis
What Does Taking Part In A Trial Typically Involve
Stott: Taking part in a clinical trial is a serious matter and it is not a decision that should be rushed or taken lightly. The decision must be based on informed consent, which means being fully aware of the risks of potential negative outcomes of a trial. Before starting any trial, a prospective participant should be given written information on the background of the research, the requirements of the study, and the contact information of all involved parties in the event of an emergency. They should also be made aware that they have the right to stop their involvement in the study at any time without question. Only when a potential participant is comfortable and satisfied with the information or material provided should they be presented with a consent form to fill in.
The nature of the study will determine many of the physical requirements observational trials might mean quarterly clinical visits, while a clinical trial assessing an experimental therapeutic could require daily self-administration of the drug.
The benefits of taking part in clinical research are many. The opportunity provides the individual with better insights into the nature of their condition. In addition, they are provided with more regular assessment and care, and have the opportunity to ask experts questions about issues that might occur in their daily lives. The risks of participation vary between studies and should be carefully and clearly explained before anyone volunteers to take part.
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Rostock International Parkinson’s Disease Study
Sorry, in progress, not accepting new patients
Rostock International Parkinson’s Disease Study – An International, multicentre, epidemiological observational study aiming at identification of 1,500 LRRK2-positive patients, the identification of 1,500 non-LRRK2 PD patients and the establishment of a candidate biomarker in the LRRK2-positive cohort.
at UCSD
Sorry, in progress, not accepting new patients
Safety and efficacy of AADC gene transfer in participants with Parkinson’s disease.
at UCSF
Why Are Clinical Trials Important In Parkinsons Disease Research
Helen Matthews, deputy CEO of The Cure Parkinsons Trust: Simply, we wont find a cure without running clinical trials to test new approaches. We cant find a cure without the thousands of Parkinsons volunteers who so generously put themselves forward to participate and support research.
Dr Simon Stott, deputy director of research at The Cure Parkinsons Trust: Any new medical treatment for humans must go through a strict process of clinical evaluation, which investigates safety and efficacy, before health regulators will allow the treatment to be used in the clinic.
We can learn a great deal about the potential biology of Parkinsons from preclinical models of the condition, but it is not until we actually test our theories in humans that we achieve real insights into the disease. Studies in large clinical cohorts are important in helping to establish a better understanding of the underlying pathology of Parkinsons and providing better methods of measuring the progression of the condition.
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Advancing Understanding Of Transportation Options
Sorry, in progress, not accepting new patients
This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will test the driving decision aid in improving decision making and quality and determine its effects on specific subpopulations of older drivers . The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.
La Jolla, California
What Causes Parkinsons Disease
The precise cause of Parkinsons disease is not yet known. Much research is being completed to try an uncover this, as it will aid in prevention and treatment. Although it is not fatal by itself, the symptoms can seriously impact quality of life. Likewise, some complications leave a patient at greater risk of injury or other health issues.
In addition to dopamine-producing nerve cells, people with Parkinsons lose nerve endings responsible for producing norepinephrine, which regulates the autonomic nervous system. This leads to disruption in automatic functions like heart rate and blood pressure.
Current Parkinsons research focuses on the presence of Lewy bodies in patients brain cells. These unusual clumps of protein may be related to certain genetic mutations.
Parkinsons clinical trials attract more participants than many other chronic diseases. The Michael J. Fox foundation is a leading organization dedicated to finding more advanced treatments and a cure for Parkinsons disease. Millions of dollars from other outside resources have also been donated to study it. A variety of new clinical resources for Parkinsons are in advanced stages of development.
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Benefits And Risks Of Clinical Trials
Participating in a clinical trial can be a rewarding experience. Consider the following benefits when deciding if you should join a clinical trial:
- You will have access to leading healthcare professionals, cutting-edge new treatments and high standards of care.
- Joining a clinical trial can increase your knowledge and understanding of your disease.
- People who take part in clinical trials are contributing to science that may benefit themselves and others. The medications that you take now are available only because people before you have volunteered in clinical trials.
Although every effort is made to ensure that clinical trials are as safe as possible, clinical trials that test new therapies are experiments and can involve risks.
Here are some of the risks to consider:
- There may be undesirable side effects to the treatment. A health professional will explain possible risks and side effects during the informed consent process.
- The treatment may not be effective for the participant.
Stanford Movement Disorders Center Clinical Trials
Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease Sponsor: Medtronic, Inc.Purpose: The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS for Parkinsons disease. Study status: Open, enrollment ongoing Research coordinator: Cameron Diep
Blood biomarkers study in REM sleep behavior disorder Purpose: studying neuroinflammation and immune protective factors in patients with RBDStudy status: Open, enrollment ongoingResearch Coordinator: Ana Cahuas 650 721 5489
Home diagnosis of REM sleep behavior disorder using wearable sleep trackersPurpose: developing a machine learning method to diagnose RBD in the home environment with wrist-worn actigraphyStudy status: Open, enrollment ongoingResearch Coordinator: Ana Cahuas
U19 North American Prodromal Synucleinopathy consortium Purpose: Neuroprotection trial planning in REM sleep behavior disorder Study status: Open, enrollment ongoingResearch Coordinator: Vincent Nguyen
Sodium Oxybate in Refractory REM Sleep Behavior Disorder: A Randomized Controlled StudyPurpose: This study evaluates the efficacy of sodium oxybate in individuals with and without Parkinsons disease who act out their dreams and do not respond to usual therapies.Study status: Open, enrollment ongoingResearch Coordinator: Ana Cahuas
Study status: Open, Enrollment ongoingResearch coordinator: Maria-Lucia Campos
Study Status: Open, enrollment ongoingResearch coordinator: Christina Wyss-Coray
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Apda Center For Advanced Research
Boston University School of Medicine is home to an Advanced Center for Parkinsons Research supported by the American Parkinson Disease Association. The Center is directed by Marie Hélène Saint-Hilaire, MD, FRCPC, with a comprehensive team of experts.
APDA Centers for Advanced Research must meet the highest academic standards and be distinguished leaders in the field of PD research. There are eight such centers across the country.
The funding of this Center supports a large research program, which includes: Biomarker studies, studies of non-motor symptoms, studies of self-management strategies, an active clinical trials program, 3500 patient visits per year, a Deep Brain Stimulation program, and a fellowship program in Movement Disorders.
Parkinsons disease affects more than 1 million people in the United States annually, with at least 60,000 new cases diagnosed each year. The chronic and progressive neurological condition is the second most common neurodegenerative aging disorder, after Alzheimers disease.
For more information contact:
Medical Director: Marie-Hélène Saint Hilaire, MD, FRCPPhone: 800-651-8466
Assessment Of The Efficacy Of Cell Transplants With Immunostaining Characterization
In the case of mDA progenitor neuron specifications, positive gene expression of common transcription factors FOXA2, LMX1A, and OTX2 and negative markers such as Afp, Gata4, and Brachyury have been quantitatively analyzed . More importantly, the upregulation and downregulation of these markers at a given stage in vitro governs the efficiency of cell fate determination. Unfortunately, these markers have been shown to coexpress in the diencephalic progenitor cells of the subthalamic nucleus . Furthermore, the expression of the positive genetic marker for DA neurons, tyrosine hydroxylase , a rate-limiting enzyme in dopamine synthesis , and the levels of GIRK2 have also been observed in many cell types in vitro . Moreover, common positive markers used to isolate high-quality DA progenitor cells include EN1 and SPRY1 Nurr1 FOXA2, LMX1B, and MSX1 , and the bicoid-related homeodomain factor Ptx3/Pitx3 . It is noteworthy that some discrepancies have been found with the requirement for the presence of floor plate-specific cell surface marker CORIN expression . A more recent study has identified a cell surface marker integrin-associated protein as a positive marker for FOXA2-positive DA progenitor cells .
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Jubiwatch Device Targets Medication Adherence
CST-103 is an agonist of beta-2 adrenoceptors. It is intended to restore the functionality of the faulty noradrenergic system in people with neurological diseases.
Beta-2 agonists like CST-103 activate multiple cell types in the brain, leading to both maintenance of cognitive function and restoration of complex homeostatic pathways critical for protecting brain health, said Anthony Ford, PhD, CuraSens CEO. This approach represents an important step towards improving daily activities for millions of poorly managed patients, and offers a longer term option for limiting and potentially reversing pathological decline.
The new data come from a Phase 1 clinical trial that enrolled eight people with Parkinsons or mild cognitive impairment , which is is the diagnosis when a person has notable cognitive and/or memory problems, but still can function independently in day-to-day life. Some people with MCI will go on to develop more serious forms of dementia, such as Alzheimers disease.
The eight trial participants were given a single 80 microgram dose of CST-103. Blood flow in their brains, sometimes called cerebral perfusion, was evaluated via MRI scan before taking the therapy, and again three hours after taking it.
Results showed that CST-103 significantly increased cerebral perfusion in several important regions of the brain, including the hippocampus , the thalamus and the amygdala . In all regions, the average increase was more than 13%.
Trial Of Parkinson’s And Zoledronic Acid
open to eligible people ages 60 years and up
This home-based study is a randomized placebo-controlled trial of a single infusion of zoledronic acid-5 mg for the prevention of fractures in men and women aged 60 years and older with Parkinson’s disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging.
San Francisco, California
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Assessment Of The Efficacy Of Cell Transplants With Imaging
Last, concurrent with the high demand for the optimization of cell graft visualization in PD, growing emphasis has been placed on enhancing the sensitivity and precision of the spatiotemporal resolution of functional neuroimaging. En route to successful cell transplantation as a therapeutic regenerative method for Parkinsons disease, neuroimaging techniques have to be employed for better patient care. Some key features required to elucidate the therapeutic efficacy of transplanted cells for clinical diagnostics are innervation, survival, differentiation, and functional biochemistry composition. Furthermore, it is crucial that these imaging techniques are time efficient, safe, non-invasive, and allow repeated measures in an individual to determine longitudinal post-operative progression in patients with cell transplantation . In this section, we summarize the pros and cons of current imaging modalities used in tracking cell grafts in PD and their respective biomarkers .
Table 2. Imaging modalities used in cell transplantation for PD.
The Challenge Of Oral Health In Parkinsons Disease
However, with long-term use of levodopa, most patients experience motor complications such as involuntary movements, called dyskinesia, as the medication loses effectiveness or wears off s0-called off periods before the next dose can be taken. As these symptoms advance, treatment poses additional challenges and can affect patients quality of life.
With the progression of Parkinsons disease as a common neurodegenerative disease, the symptoms will become worse, and the patients will need long-term care, Yang Rongbing, president of Luye Pharma Group, said in a press release. This presents a huge challenge to their quality of life and their familys ability to take care of them.
We want to provide a new treatment option for those patients, to help them reduce disease burdens and slow down disease progression, and to improve the quality of life for themselves and their family members, Rongbing said.
LY03009 is a once-a-month, long-acting microsphere injection that provides continuous dopamine stimulation, which aims to delay levodopa treatment, provide long-term benefits, and slow disease progression.
The therapy is designed to improve motor symptoms by shortening the off periods, which would postpone the onset of dyskinesia and nighttime symptoms and improve non-motor symptoms. Moreover, because of its extended-release formulation, patients will need fewer treatments, which may simplify the treatment regimen and increase patient compliance.
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Icipate In A Research Study
Many research studies into Parkinson’s disease need human volunteers to answer specific health questions. Your participation in these research studies allows you to access new treatments for Parkinson’s disease before they are widely available and contributes to medical research.
Are There Clinical Trials For Parkinsons
A clinical trial is a research program done with patients to evaluate a new medical treatment, drug, or device. The goal is to find new and improved ways to treat diseases and conditions.
During a clinical trial, doctors use the best available treatment as a standard to evaluate new treatments. The new treatments are hoped to be at least as effective as — or possibly more effective than — the standard.
New treatment options are first carefully researched in the laboratory — in the test tube and in animals. Treatments most likely to work are further evaluated in a small group of humans. Then, they may be moved to a larger clinical trial.
When a new medical treatment is studied for the first time in humans, scientists don’t know exactly how itâll work. Any new treatment has possible risks and benefits. Clinical trials help doctors find out:
- If the treatment is safe and effective
- If the treatment could be better than treatments currently available
- The side effects of the treatment
- Possible risks of the treatment
Some advantages of taking part in a clinical trial are:
Some disadvantages of participating in a clinical trial are:
If you take part in a clinical trial, you may notice some changes in your care:
If you think you might want to take part in a clinical trial, find out as much as possible about the study before you decide. You can ask:
For information about ongoing Parkinson’s disease studies, contact the National Institutes of Health.
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