Interposed Nucleus aDBS for Ataxia

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 — DEVICE
  This device will be surgically implanted into the interposed nucleus of the cerebellum.

Study Details

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.

Key Dates

Start date

Mar 31, 2026

Status verified

Dec 2025

Primary completion

Mar 31, 2031

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)
  Participants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. Approximately one month after implantation, participants will begin conventional DBS (cDBS) programming to identify optimal stimulation parameters, including amplitude, contact configuration, frequency, and pulse width, and to assess stimulation-related adverse effects and device function. Approximately nine months after implantation, stimulation settings will be transitioned to adaptive DBS (aDBS), in which stimulation amplitude is automatically adjusted based on recorded neural activity. Adaptive DBS will be used to evaluate the feasibility, safety, and tolerability of cerebellar aDBS. Clinical outcomes, symptoms, and potential side effects will be assessed throughout the study using participant self-reports, validated clinical rating scales, and wearable devices to collect movement and sleep data.

Primary Outcome Measure

The identification of a physiological signal to use as the aDBS feedback signal [ Time Frame: From baseline through study completion, about 2 years. ]

Central Contacts

• Coralie de Hemptinne, PhD
  (352) 733-3048
  [email protected]
• Julia C Gonzalez, BA
  [email protected]

Locations (1)

Find similar trials in Gainesville, FL

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