Adaptive DBS for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help people with Parkinson's disease improve their walking. It uses the Summit RC+S, a deep brain stimulation device that senses body movements and adjusts brain stimulation to aid walking. The trial compares two types of brain stimulation: continuous and adaptive, which changes based on movement. Suitable participants have Parkinson's disease with walking issues, such as slowed or shuffling steps, and have already had this device implanted. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mobility for those with Parkinson's.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves patients who have not had adequate relief from oral medications, it seems likely that you can continue your current treatment.
What prior data suggests that this adaptive DBS device is safe for improving gait functions in Parkinson's Disease patients?
Research has shown that both adaptive (closed-loop) and continuous (open-loop) deep brain stimulation (DBS) are generally safe for treating Parkinson's disease. Studies have found DBS to be a safe and effective treatment for several brain-related conditions, including Parkinson’s. Long-term studies on adaptive DBS found it to be safe and effective, with no serious safety issues reported. This method adjusts stimulation based on the patient's movements, offering personalized treatment.
Continuous DBS has also been well-researched and is widely considered safe. It provides constant stimulation without adjusting for movement. Both methods use the Summit RC+S device, which previous studies have shown to reduce the need for other Parkinson’s medications, like levodopa, by more than 80%.
Overall, research supports the safety of both DBS methods, making them promising options for improving movement in people with Parkinson’s disease.12345Why are researchers excited about this trial?
Researchers are excited about Adaptive DBS for Parkinson's Disease because it offers a new approach to deep brain stimulation. Unlike traditional treatments that provide continuous (open-loop) stimulation, this method includes a movement state-dependent adaptive (closed-loop) system. This means the device can adjust stimulation in real-time based on the patient's movement needs, potentially improving symptom control and reducing side effects. This tailored approach could lead to better outcomes for patients by providing more precise and effective treatment.
What evidence suggests that this trial's treatments could be effective for improving gait in Parkinson's Disease?
This trial will compare two methods of deep brain stimulation (DBS) for managing symptoms in people with Parkinson's disease. Participants in one arm will receive continuous (open-loop) DBS. Research indicates this method helps reduce movement problems and can significantly decrease the need for medications like levodopa. Participants in another arm will receive movement state-dependent adaptive (closed-loop) DBS, which might offer even better results. This method automatically adjusts its settings based on the person's movements, potentially leading to more precise symptom control and fewer side effects. Some studies suggest adaptive DBS could improve movement problems and overall quality of life in Parkinson's patients better than the traditional method. While both methods show promise, adaptive DBS might provide a more personalized treatment approach.678910
Who Is on the Research Team?
Doris Wang, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people aged 21-75 with Parkinson's disease who have had motor symptoms for at least 3 years, have gait problems not fully helped by medication, and already have the Summit RC+S deep brain stimulation device implanted. Participants must be able to give consent and not have major memory or thinking issues.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adaptive and open-loop DBS settings randomized for 7-day periods to evaluate gait and motor function improvements
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Summit RC+S
Trial Overview
The study tests a new way of using deep brain stimulation (DBS) that adjusts automatically based on movement state to improve walking in Parkinson's patients. It uses the Summit RC+S device to sense brain activity and change stimulation settings as needed.
How Is the Trial Designed?
2
Treatment groups
Active Control
Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.
Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving movement state-dependent adaptive (closed-loop) deep brain stimulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Doris Wang, MD, PhD
Lead Sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborator
Burroughs Wellcome
Industry Sponsor
Citations
Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain ...
Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain Stimulation Trial in Parkinson Disease Using Summit RC + S. Neurosurgery ...
Deep Brain Stimulation Clinical Trials
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of ...
Chronic dual target continuous and externally controlled ...
Chronic dual target continuous and externally controlled adaptive deep brain stimulation with Summit RC+S are equally effective for motor symptom control in ...
Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain ...
Combined DBS improved PD symptom control, allowing >80% levodopa medication reduction. There was a greater decrease in off-medication motor Unified PD Rating ...
Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain ...
Deep brain stimulation (DBS) is an effective therapy in advanced Parkinson disease (PD). Although both subthalamic nucleus (STN) and globus ...
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frontiersin.org
frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.714256/fullAnalysis-rcs-data: Open-Source Toolbox for the Ingestion, ...
The Summit RC+S system consists of two surface or depth leads that are implanted in the brain and a neurostimulator (INS) implanted in the chest. The system is ...
NCT03582891 | The Motor Network in Parkinson's Disease ...
Using the RC+S pulse generator, investigators will measure cortical biomarkers of hyper and hypokinesia in Parkinson's and dystonia patients to develop an ...
BrainSense™ Adaptive DBS (aDBS)
ADAPT-PD clinical trial6. The ADAPT-PD clinical trial's intent was to determine safety and effectiveness of the adaptive feature.
Long-Term Personalized Adaptive Deep Brain Stimulation ...
Meaning Long-term aDBS provided tolerable, effective, and safe therapy in persons with Parkinson disease whose symptoms were previously stable ...
Chronic adaptive deep brain stimulation in Parkinson's disease
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a safe and highly effective neurosurgical treatment, and a well-established, evidence-based ...
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