Deep Brain Stimulation for Spinocerebellar Ataxia

Last updated: March 16, 2026
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Friedreich's Ataxia

Spinocerebellar Disorders

Treatment

Deep Brain Stimulation (DBS)

Clinical Study ID

NCT07288437
25-44582
  • Ages 21-89
  • All Genders

Study 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

Inclusion Criteria:

  1. A diagnosis of SCA6 by a Movement Disorders specialist following establishedcriteria 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) ratingscale.

  4. Ability to walk with or without support (score < 8 on the 'gait' subsection of theSARA 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

Exclusion Criteria:

  1. Inability or unwillingness to comply with the study protocol.

  2. History of previously implanted neurostimulators, pacemakers, defibrillators, ormetallic head implants.

  3. Severe cognitive impairment or dementia, defined as a score < 21 on the MontrealCognitive Assessment (MoCA).

  4. Evidence of ataxia due to other etiologies, including but not limited to:

  5. Genetic/inherited disorders other than SCA6.

  6. Acquired causes: tramautic brain injury, multiple sclerosis, paraneplasticcerebellar degeneration, infections or post-infectious cerebellitis, autoimmuneataxias (e.g., anti-GAD, gluten ataxia).

  7. Toxic/metabolic causes: alcoholic cerebellar degeneration, vitamindeficiencies.

  8. Structural, vascular, or neoplastic causes: cerebellar stroke, tumors,congenital malformations.

  9. Suspected multiple system atrophy-cerebellar type (MSA-C).

  10. The presence of active and untreated psychiatric illness, severe depression (BeckDepression Inventory ≥ 21), or personality disorder at the discretion of the studyteam.

  11. Coagulopathy, uncontrolled epilepsy, or other medical condition considered to placethe patient at elevated risk for surgical complications. Presence of a concomitantmedical condition that, in the investigator's opinion, may interfere with the studyparticipation or gait/balance, for example, severe arthritis.

  12. Presence of a concominant medical condition that, in the investigator's opinion, mayinterfere with the study participation or gait/balance, for example, severearthritis.

  13. Requirement of diathermy, electroconvulsive therapy, or transcranial magneticstimulation.

  14. Pregnancy or lactation.

  15. Active suicidal ideation, defined as fined as a "Yes" response to questions #2-5 onthe Columbia Suicide Severity Rating Scale, C-SSRS.

  16. Refractory Epilepsy.

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Deep Brain Stimulation (DBS)
Phase:
Study Start date:
March 01, 2026
Estimated Completion Date:
March 31, 2031

Connect with a study center

  • UCSF Weill Institute for Neurosciences

    San Francisco, California 94158
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

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