Deep Brain Stimulation for Spinocerebellar Ataxias
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and feasibility of deep brain stimulation (DBS) in the deep cerebellar nuclei (DCN) in patients with Spinocerebellar Ataxia (SCA) types 1 and 3.
Primary Objective: The incidence and nature of treatment-related adverse events across the entire study, including serious treatment-related adverse events such as intracerebral hemorrhage, infection, and serious or unanticipated adverse device effects (SADEs and UADEs).
Secondary/Exploratory Objectives:
* Evaluation of the effect of Dentate Nucleus (DN) - Deep Brain Stimulation (DBS). Ataxia severity will be quantified using the Scale of Assessment and Rating of Ataxia (SARA), Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia), and kinematics.
* To characterize electrophysiological activity across the cerebellothalamocorticomuscular (CTCM) network at rest and during motor behaviors.
* To examine how DN-DBS modulates oscillatory activity and coupling across the CTCM circuit in relation to improvements in controlling ataxia.
Who Is on the Research Team?
Gordon Baltuch, MD
Principal Investigator
CUIMC
Sheng-Han Kuo, MD
Principal Investigator
CUIMC
Are You a Good Fit for This Trial?
This trial is for people diagnosed with Spinocerebellar Ataxia type 1 or type 3. Participants should be adults who meet specific medical criteria and do not have conditions that would make surgery unsafe.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Deep Brain Stimulation (DBS) System
Trial Overview
The study is testing the safety and practicality of using deep brain stimulation (DBS) in a part of the brain called the cerebellar nuclei to help manage symptoms in SCA1 and SCA3 patients.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will undergo surgical implantation of the DBS leads, followed by a second surgery to implant a pulse generator (IPG) which generates electricity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gordon H. Baltuch
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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