Adaptive deep brain stimulation in the cerebellum for spinocerebellar ataxia type 6

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will implant a Medtronic Percept Primary Cell Neurostimulator into the dentate nucleus of the cerebellum in five adults with genetically confirmed SCA6 who continue to have cerebellar symptoms. The device uses adaptive deep brain stimulation (aDBS) that monitors brain signals and automatically adjusts stimulation strength, timing, and pattern to the patient's needs. The primary goals are to determine the feasibility, safety, and tolerability of cerebellar aDBS, with clinical scales such as SARA and cognitive screening (MoCA) guiding eligibility and outcomes. Participants will undergo surgical implantation at UCSF with scheduled postoperative follow-up visits to monitor effects and adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCSF Weill Institute for Neurosciences
  San Francisco, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Not yet recruiting

Study contacts

• Principal investigator: Marta San Luciano Palenzuela, MD, PhD — University of California, San Francisco
• Study coordinator: Marta San Luciano Palenzuela, MD, PhD
• Email: Marta.SanLucianoPalenzuela@ucsf.edu
• Phone: (415) 353-2311

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for Spinocerebellar Ataxias in Hong Kong

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.