Deep Brain Stimulation for Spinocerebellar Ataxia (NCT07288437) | Clinical Trial Compass
RecruitingNot Applicable
Deep Brain Stimulation for Spinocerebellar Ataxia
United States5 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range21 Years – 89 Years
SexALL
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Inclusion criteria
✓. A diagnosis of SCA6 by a Movement Disorders specialist following established criteria recommended by the Movement Disorders Society.
✓. A positive genetic test for SCA6.
✓. A total scale ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) rating scale.
✓. Ability to walk with or without support (score \< 8 on the 'gait' subsection of the SARA rating scale).
✓. Age ≥ 21 years and \< 89 years.
✓. Ability to give informed consent for the study.
✓. Be able to understand the study protocol.
Exclusion criteria
✕. Inability or unwillingness to comply with the study protocol.
✕. History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants.
✕. Severe cognitive impairment or dementia, defined as a score \< 21 on the Montreal Cognitive Assessment (MoCA).
What they're measuring
1
Average total score for the Assessment and Rating of Ataxia (SARA)
Timeframe: From baseline through study completion, about 2 years.
2
Average total Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia) Score
Timeframe: From baseline through study completion, about 2 years.