Cerebellar DBS in SCA1 and SCA3 Study

Conditions

• Spinocerebellar Ataxia Genotype Type 1
• Spinocerebellar Ataxia Genotype Type 3

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• UG3NS140720 Deep Brain Stimulation System — DEVICE
  The UG3NS140720 Deep Brain Stimulation System is primarily comprised of components from the Medtronic Percept™ system, which is approved in the U.S. by the FDA for unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus as adjunctive therapy for ET, cerebellar outflow tremor, and MS-related tremor. This system is also approved to be used on patients with neurologic disorders such as Parkinson's disease, dystonia, or epilepsy. The FDA has not approved any DBS system for the stimulation of the Deep Cerebellar Nuclei (DCN) for this patient population. Deep brain stimulation (DBS) utilizes surgically implanted electrodes and a neurostimulator to deliver electrical energy to specific targeted structures deep within either one or both hemispheres of the brain.

Study Details

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.

Key Dates

First listed

Aug 7, 2026

Start date

Oct 31, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2029

Completion

Jun 30, 2030

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: DBS Intervention
  Participants will undergo surgical implantation of the DBS leads, followed by a second surgery to implant a pulse generator (IPG) which generates electricity.

Primary Outcome Measure

Incidence of treatment-related adverse events [ Time Frame: Up to 72 months ]

Central Contacts

• Natasha Desai
  347-882-4315
  [email protected]
• Gordon Baltuch, MD, PhD
  [email protected]

Locations (2)

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