NCT07288437 Deep Brain Stimulation for Spinocerebellar Ataxia
| NCT ID | NCT07288437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Spinocerebellar Ataxia (SCA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2026-03 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2026-03 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test the safety of placing Deep Brain Stimulators (DBS) in the cerebellum and using electrical stimulation of that part of the brain to treat symptoms related to the participants spinocerebellar ataxia. Five adults diagnosed with spinocerebellar ataxia type 6 (SCA6) with inadequate cerebellar symptom relief will be implanted with a Medtronic Percept Primary Cell Neurostimulator. The device will be implanted into the dentate nucleus, which is a structure located within the cerebellum that is responsible for controlling movement and balance. 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.
Eligibility Criteria
Inclusion Criteria: 1. A diagnosis of SCA6 by a Movement Disorders specialist following established criteria recommended by the Movement Disorders Society. 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: 1. Inability or unwillingness to comply with the study protocol. 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.
Contact & Investigator
Marta San Luciano Palenzuela, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07288437 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 89 Years, studying Spinocerebellar Ataxia (SCA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07288437 currently recruiting?
Yes, NCT07288437 is actively recruiting participants. Contact the research team at Marta.SanLucianoPalenzuela@ucsf.edu for enrollment information.
Where is the NCT07288437 trial being conducted?
This trial is being conducted at San Francisco, United States, San Francisco, United States.
Who is sponsoring the NCT07288437 clinical trial?
NCT07288437 is sponsored by University of California, San Francisco. The principal investigator is Marta San Luciano Palenzuela, MD, PhD at University of California, San Francisco. The trial plans to enroll 5 participants.