Deep Brain Stimulation for Spinocerebellar Ataxia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment called Deep Brain Stimulation (DBS) to assist individuals with spinocerebellar ataxia type 6 (SCA6), a condition affecting movement and balance. Researchers aim to determine if placing a small device in the brain can safely improve symptoms by sending electrical signals to the brain area responsible for movement. The trial will specifically test a new kind of DBS that automatically adjusts its signals based on the individual's needs. Suitable candidates have been diagnosed with SCA6, experience significant movement issues, and have not found relief with other treatments. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for SCA6.
Will I have to stop taking my current medications?
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 understand any specific requirements.
What prior data suggests that this device is safe for treating spinocerebellar ataxia?
Research shows that deep brain stimulation (DBS) targeting the dentate nucleus is generally safe and well-tolerated. Studies have found that this procedure can effectively reduce tremors without causing major side effects. In one study, patients monitored for six months after treatment experienced positive results with few negative effects. This suggests that DBS could be a good option for managing symptoms in people with spinocerebellar ataxia type 6 (SCA6).
This trial includes adaptive DBS (aDBS), which automatically adjusts stimulation based on the patient's needs. While specific data on aDBS is still being gathered, the overall safety of DBS in similar situations appears promising. Although the treatment remains under study, past evidence suggests it is safe for use in humans.12345Why are researchers excited about this trial?
Most treatments for spinocerebellar ataxia focus on symptom management with medications like physical therapy, occupational therapy, and sometimes medications to alleviate specific symptoms. However, Deep Brain Stimulation (DBS) offers a unique approach by directly targeting the brain's electrical activity. Researchers are particularly excited about the use of Adaptive Deep Brain Stimulation (aDBS) because it can adjust the stimulation in real-time based on the patient's needs, potentially improving precision and outcomes. This method could lead to better management of symptoms and enhance the quality of life for patients with spinocerebellar ataxia.
What evidence suggests that adaptive deep brain stimulation is effective for spinocerebellar ataxia?
Research has shown that deep brain stimulation (DBS), targeting the dentate nucleus in the brain, can help manage symptoms of spinocerebellar ataxia. One study with patients who had various types of this condition found that DBS improved their movement and balance over six months. While noninvasive methods for the cerebellum have shown positive results, DBS, which involves surgery, might be more effective. In this trial, participants will receive Adaptive DBS (aDBS), which adjusts stimulation based on brain activity, potentially enhancing its effectiveness in managing symptoms. Overall, these early findings suggest that DBS could be a helpful tool in treating symptoms of spinocerebellar ataxia.12367
Who Is on the Research Team?
Marta San Luciano Palenzuela, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults with spinocerebellar ataxia type 6 (SCA6) who haven't found relief from cerebellar symptoms. Participants will have a Medtronic Percept Primary Cell Neurostimulator implanted in their brain.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Programming
Participants undergo DBS surgery in the cerebellum, followed by conventional DBS programming to identify stimulation parameters and ensure proper device function
Adaptive Deep Brain Stimulation (aDBS)
Nine months after implantation, system settings are switched to aDBS to evaluate feasibility, safety, and tolerability. Symptoms and side effects are assessed using self-reports, clinical scales, and wearable devices
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Deep Brain Stimulation (DBS)
Trial Overview
The study tests the safety of Deep Brain Stimulation (DBS) using an adaptive system that adjusts to patient needs in real-time, targeting the dentate nucleus to improve movement and balance.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
One month after patients undergo DBS surgery in the cerebellum, conventional deep brain stimulation (cDBS) programming will begin to identify stimulation parameters (such as amplitude, contact, frequency, and pulse width) and ensure no adverse wide effects are witness. This phase also allows the study team to make sure device and electrode placement are working as intended. About nine months after implantation, the investigators will switch system settings over to aDBS to evaluate the feasibility, safety, and tolerability in the dentate nucleus of the cerebellum. Symptoms and side effects will be assessed by patients' self-reports, validated clinical scales, and wearable devices, which will be used to track movements and sleep data.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Raynor Cerebellum Project
Collaborator
Citations
Deep Brain Stimulation for Spinocerebellar Ataxia
This study will evaluate the feasibility, safety, and tolerability of aDBS in SCA6 patients. Official Title. Adaptive Deep Brain Stimulation ...
Dentate Nucleus Deep Brain Stimulation for ...
Although noninvasive cerebellar neuromodulation has shown positive outcomes, invasive approaches such as deep brain stimulation (DBS) remain ...
3.
movementdisorders.onlinelibrary.wiley.com
movementdisorders.onlinelibrary.wiley.com/doi/abs/10.1002/mds.70116Dentate Nucleus Deep Brain Stimulation for Spinocerebellar ...
This study assessed the treatment outcomes of DBS targeting the cerebellar dentate nucleus (DN) in SCA patients over a 6-month follow-up.
Dentate nucleus deep brain stimulation for spinocerebellar ...
This study evaluated the treatment outcomes of DBS targeting the cerebellar dentate nucleus (DN) in six SCA patients (SCA1, SCA3, SCA12) over a ...
Cerebellar deep brain stimulation for chronic post-stroke ...
Our findings support the safety and feasibility of deep brain stimulation to the cerebellar dentate nucleus as a promising tool for modulation ...
Safety and Outcomes of Dentate Nucleus Deep Brain ...
DN DBS is a safe and well tolerated procedure that is effective in alleviating cerebellar tremor.
7.
researchgate.net
researchgate.net/publication/397418620_Dentate_Nucleus_Deep_Brain_Stimulation_for_Spinocerebellar_Ataxia_Results_of_a_6-Month_Follow-UpDentate Nucleus Deep Brain Stimulation for ...
Results Acute active DBS led to an increase in ipsilesional corticomotor excitability evident as a 5.2 % maximal stimulator output (MSO) ...
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