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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Deep Brain Stimulation (DBS)
DeviceThis device will be surgically implanted into the dentate nucleus of the cerebellum.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Adaptive Deep Brain Stimulation (aDBS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Average total score for the Assessment and Rating of Ataxia (SARA)
SARA is a clinical scale that assesses a variety of different impairments for individuals with cerebellar ataxia. The scale includes 8 different items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test. The total amount of points on SARA ranges from 0 (no ataxia) to 40 (most severe ataxia). This study requires participants to have a minimum SARA score of at least 8 so that people who are relatively early in their disease course with limited cerebellar degeneration can be included.
Time frame
From baseline through study completion, about 2 years.2
Average total Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia) Score
PROM-Ataxia is a 3-domain, 70-item questionnaire used for the assessment of ataxia-related symptoms. It incorporates a series of questions ranging to the impact of cerebellar dysfunction on physical abilities, activities of daily living, and cognitive-emotional challenges. The maximum severity score on PROM-Ataxia is 280, where all 70 questions are scored on a 0-4 Likert scale. 0 represents never and 4 represents always.
Time frame
From baseline through study completion, about 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Raynor Cerebellum Project
Collaborator
Source ClinicalTrials.gov