Deep Brain Stimulation Clinical Trials

Clinical trials related to Deep Brain Stimulation Procedure

Adaptive Deep Brain Stimulation Targeting the Dentate Nucleus to Treat Spinocerebellar Ataxia

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 89
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UCSF Weill Institute for Neurosciences
RECRUITING
San Francisco
University of California, San Francisco
NOT_YET_RECRUITING
San Francisco
Contact Information
Primary
Marta San Luciano Palenzuela, MD, PhD
Marta.SanLucianoPalenzuela@ucsf.edu
(415) 353-2311
Backup
Karson J Franjieh, BS
karson.franjieh@ucsf.edu
415-755-8954
Time Frame
Start Date: 2026-03
Estimated Completion Date: 2031-03
Participants
Target number of participants: 5
Treatments
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.
Sponsors
Leads: University of California, San Francisco
Collaborators: Raynor Cerebellum Project

This content was sourced from clinicaltrials.gov