RecruitingNot Applicable

Interposed Nucleus aDBS for Ataxia

United States5 participantsStarted 2026-06-02

Plain-language 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.

Who can participate

Age range

21 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 score ≥ 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 * Ability to understand the study protocol Exclusion Criteria: * Inability or unwillingness to comply with the study protocol * History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants * Severe cognitive impairment or dementia, defined as a score \<21 on the Montreal Cognitive Assessment (MOCA) * Evidence of ataxia due to other etiologies, including but not limited to: * Genetic/inherited disorders other than SCA6 * Acquired causes: traumatic brain injury, multiple sclerosis, paraneoplastic cerebellar degeneration, infections or post-infectious cerebellitis, autoimmune ataxias (e.g., anti-GAD, gluten ataxia) * Toxic/metabolic causes: alcoholic cerebellar degeneration, vitamin deficiencies * Structural, vascular, or neoplastic causes: cerebellar stroke, tumors, congenital malformations * Suspected multiple system atrophy-cerebellar type (MSA-C) * Presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or person…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The identification of a physiological signal to use as the aDBS feedback signal

Timeframe: From baseline through study completion, about 2 years.

The incidence of unexpected adverse events and serious adverse events with aDBS compared to baseline

Timeframe: From baseline through study completion, about 2 years.

Trial details

NCT IDNCT07325487

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06

Contact for this trial

Coralie de Hemptinne, PhD

(352) 733-3048 Coralie.deHemptinne@neurology.ufl.edu

View on ClinicalTrials.gov More Spinocerebellar Ataxia (SCA) trials

Plain-language summary

Who can participate

Age range

21 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The identification of a physiological signal to use as the aDBS feedback signal

Timeframe: From baseline through study completion, about 2 years.

The incidence of unexpected adverse events and serious adverse events with aDBS compared to baseline

Timeframe: From baseline through study completion, about 2 years.