Deep Brain Stimulation for Ataxia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for spinocerebellar ataxia type 6 (SCA6), a condition affecting balance and coordination. The treatment, Interposed Nucleus aDBS, involves implanting a device in the brain that adjusts its activity based on brain function, aiming to improve symptoms. Individuals diagnosed with SCA6, who have a positive genetic test for it, and can walk with or without support might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
What prior data suggests that cerebellar adaptive deep brain stimulation (aDBS) is safe for adults with spinocerebellar ataxia type 6 (SCA6)?
Research has shown that deep brain stimulation (DBS) is generally safe and well-tolerated for treating cerebellar tremor, based on studies with small patient groups. In these studies, patients reported no major safety issues, and any common side effects were minor.
Adaptive deep brain stimulation (aDBS) enhances this by automatically adjusting stimulation based on brain activity. Since aDBS builds on the established DBS method, it is expected to be equally safe. However, because aDBS is newer, ongoing studies closely monitor participants to ensure safety and manage any side effects. Participants in these studies assist researchers in confirming the safety of this new treatment for ataxia.12345Why are researchers excited about this trial?
Researchers are excited about Adaptive Deep Brain Stimulation (aDBS) for ataxia because it offers a new way to automatically adjust stimulation levels in the brain based on real-time neural activity. Unlike traditional DBS, which uses fixed settings, aDBS dynamically tunes the stimulation to better match the brain's needs, potentially improving symptom control and reducing side effects. This personalized approach could lead to more effective and safer management of ataxia symptoms compared to existing treatments.
What evidence suggests that adaptive deep brain stimulation is effective for spinocerebellar ataxia type 6?
Research has shown that deep brain stimulation (DBS) might help with movement problems in people with cerebellar ataxias. Early studies suggest that low-frequency DBS can improve these movement issues. This trial will specifically evaluate Adaptive Deep Brain Stimulation (aDBS), which automatically adjusts stimulation amplitude based on recorded neural activity. This treatment sends electrical signals to specific brain parts to help control movement. Evidence indicates that DBS can change brain cell activity, potentially leading to better movement control. While more research is needed, these early findings are promising for people with spinocerebellar ataxia type 6 (SCA6).12467
Who Is on the Research Team?
Coralie de Hemptinne, PhD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for adults with a specific type of movement disorder called spinocerebellar ataxia type 6 (SCA6). Participants will be part of a small group, only 5 people, to test the safety and potential benefits of a new treatment involving brain stimulation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation
Participants undergo surgical implantation of DBS leads targeting the motor interposed nucleus of the cerebellum
Conventional DBS Programming
Participants begin conventional DBS programming to identify optimal stimulation parameters
Adaptive DBS Implementation
Transition to adaptive DBS where stimulation amplitude is automatically adjusted based on recorded neural activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Interposed Nucleus aDBS
Trial Overview
The study tests cerebellar adaptive deep brain stimulation (aDBS), where surgical implants in the brain help control movement. Over two years, participants will visit the clinic up to 18 times for adjustments and monitoring how well the treatment works.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. Approximately one month after implantation, participants will begin conventional DBS (cDBS) programming to identify optimal stimulation parameters, including amplitude, contact configuration, frequency, and pulse width, and to assess stimulation-related adverse effects and device function. Approximately nine months after implantation, stimulation settings will be transitioned to adaptive DBS (aDBS), in which stimulation amplitude is automatically adjusted based on recorded neural activity. Adaptive DBS will be used to evaluate the feasibility, safety, and tolerability of cerebellar aDBS. Clinical outcomes, symptoms, and potential side effects will be assessed throughout the study using participant self-reports, validated clinical rating scales, and wearable devices to collect movement and sleep data.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Raynor Cerebellum Project
Collaborator
Citations
NCT07325487 | Interposed Nucleus aDBS for Ataxia
Study outcomes will include assessments of safety and feasibility of cerebellar aDBS, as well as preliminary evaluation of its effects on ...
Interposed Nucleus aDBS for Ataxia - ClinicalTrials.Veeva
Clinical outcomes, symptoms, and potential side effects will be assessed throughout the study using participant self-reports, validated clinical ...
Deep cerebellar stimulation reduces ataxic motor ...
Low-frequency deep cerebellar stimulation may provide a novel strategy for treating motor symptoms of degenerative cerebellar ataxias.
Cerebellar deep brain stimulation rescues Purkinje cell ...
There is evidence that DBS may also be effective in ataxia. It is not known why DBS is effective, but modulating cell activity and conferring ...
Deep Brain Stimulation for Ataxia · Info for Participants
The study tests cerebellar adaptive deep brain stimulation (aDBS), where surgical implants in the brain help control movement. Over two years, ...
Safety and Outcomes of Dentate Nucleus Deep Brain ...
DN DBS is a safe and well tolerated procedure that is effective in alleviating cerebellar tremor. In this small cohort of ataxic patients, DN ...
Real‐time field‐programmable gate array‐based closed‐ ...
Our results confirm the superiority of FPGA-based closed-loop DCN-DBS for alleviating cerebellar ataxia. This evidence supports the ...
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