Deep Brain Stimulation for Spinocerebellar Ataxia

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07288437
Status
Recruiting
Apply to this trial

Conditions

  • Spinocerebellar Ataxia (SCA)
  • Spinocerebellar Ataxia Type 6

Eligibility Criteria

Sex
ALL
Age
21 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation (DBS) — DEVICE
    This device will be surgically implanted into the dentate nucleus of the cerebellum.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Dec 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2031

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adaptive Deep Brain Stimulation (aDBS)
    One month after patients undergo DBS surgery in the cerebellum, conventional deep brain stimulation (cDBS) programming will begin to identify stimulation parameters (such as amplitude, contact, frequency, and pulse width) and ensure no adverse wide effects are witness. This phase also allows the study team to make sure device and electrode placement are working as intended. About nine months after implantation, the investigators will switch system settings over to aDBS to evaluate the feasibility, safety, and tolerability in the dentate nucleus of the cerebellum. Symptoms and side effects will be assessed by patients' self-reports, validated clinical scales, and wearable devices, which will be used to track movements and sleep data.

Primary Outcome Measure

Average total score for the Assessment and Rating of Ataxia (SARA) [ Time Frame: From baseline through study completion, about 2 years. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCSF Weill Institute for NeurosciencesSan FranciscoCalifornia94158-
University of California, San FranciscoSan FranciscoCalifornia94158
Marta San Luciano Palenzuela, MD, PhD
[email protected]
(415) 353-2311

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By research site
UCSF Weill Institute for Neurosciences· San Francisco, CAUniversity of California, San Francisco· San Francisco, CA

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