NCT07325487

Interposed Nucleus aDBS for Ataxia

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label study designed to evaluate the feasibility, safety, and preliminary efficacy of cerebellar adaptive deep brain stimulation (aDBS) in adults with spinocerebellar ataxia type 6 (SCA6). A total of 5 participants will be enrolled. Participants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. The leads will be connected to one or two implantable pulse generators capable of delivering stimulation to deep brain structures and recording neural activity. Participants will complete up to 18 in-person study visits over a 24-month follow-up period. During these visits, neural signals will be recorded under varying behavioral tasks and stimulation conditions. Early study visits will be used to identify optimal stimulation parameters and neural biomarkers associated with disease state. These biomarkers will subsequently be used to implement adaptive DBS, in which stimulation amplitude is automatically adjusted in response to recorded neural activity. Study outcomes will include assessments of safety and feasibility of cerebellar aDBS, as well as preliminary evaluation of its effects on clinical measures.

Conditions

• Spinocerebellar Ataxia (SCA)
• Spinocerebellar Ataxia Type 6

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	This device will be surgically implanted into the interposed nucleus of the cerebellum.

Timeline

• Start date: 2026-03-01
• Primary completion: 2031-03-01
• Completion: 2031-03-01
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study