Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
5 participants
INTERVENTIONAL
2026-03-31
2031-03-31
Brief Summary
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Specifically, the investigators will be using adaptive deep brain stimulation (aDBS), which analyzes brain signals and automatically adjusts the strength, timing, and pattern of stimulation according to the patient's needs at any given moment. This study will evaluate the feasibility, safety, and tolerability of aDBS in SCA6 patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adaptive Deep Brain Stimulation (aDBS)
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.
Deep Brain Stimulation (DBS)
This device will be surgically implanted into the dentate nucleus of the cerebellum.
Interventions
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Deep Brain Stimulation (DBS)
This device will be surgically implanted into the dentate nucleus of the cerebellum.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A positive genetic test for SCA6.
3. A total scale ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) rating scale.
4. Ability to walk with or without support (score \< 8 on the 'gait' subsection of the SARA rating scale).
5. Age ≥ 21 years and \< 89 years.
6. Ability to give informed consent for the study.
7. Be able to understand the study protocol.
Exclusion Criteria
2. History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants.
3. Severe cognitive impairment or dementia, defined as a score \< 21 on the Montreal Cognitive Assessment (MoCA).
4. Evidence of ataxia due to other etiologies, including but not limited to:
1. Genetic/inherited disorders other than SCA6.
2. Acquired causes: tramautic brain injury, multiple sclerosis, paraneplastic cerebellar degeneration, infections or post-infectious cerebellitis, autoimmune ataxias (e.g., anti-GAD, gluten ataxia).
3. Toxic/metabolic causes: alcoholic cerebellar degeneration, vitamin deficiencies.
4. Structural, vascular, or neoplastic causes: cerebellar stroke, tumors, congenital malformations.
5. Suspected multiple system atrophy-cerebellar type (MSA-C).
5. The presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or personality disorder at the discretion of the study team.
6. Coagulopathy, uncontrolled epilepsy, or other medical condition considered to place the patient at elevated risk for surgical complications. Presence of a concomitant medical condition that, in the investigator's opinion, may interfere with the study participation or gait/balance, for example, severe arthritis.
7. Presence of a concominant medical condition that, in the investigator's opinion, may interfere with the study participation or gait/balance, for example, severe arthritis.
8. Requirement of diathermy, electroconvulsive therapy, or transcranial magnetic stimulation.
9. Pregnancy or lactation.
10. Active suicidal ideation, defined as fined as a "Yes" response to questions #2-5 on the Columbia Suicide Severity Rating Scale, C-SSRS.
11. Refractory Epilepsy.
21 Years
89 Years
ALL
No
Sponsors
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Raynor Cerebellum Project
UNKNOWN
University of California, San Francisco
OTHER
Responsible Party
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Marta San Luciano Palenzuela, MD
Professor of Neurology
Principal Investigators
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Marta San Luciano Palenzuela, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Marta San Luciano Palenzuela, MD, PhD
Role: primary
Other Identifiers
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25-44582
Identifier Type: -
Identifier Source: org_study_id