Deep Brain Stimulation for Spinocerebellar Ataxia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-89
SponsorUniversity of California, San Francisco
About this trial
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
Qualifiers
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).
Disqualifiers
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).
Genetic/inherited disorders other than SCA6.
Trial design
Treatments tested in this trial
- Deep Brain Stimulation (DBS)
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, San Francisco
Lead sponsor
Raynor Cerebellum Project
Collaborator
Source ClinicalTrials.gov