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Adaptive Deep Brain Stimulation for Spinocerebellar Ataxia Type 6

This study is testing a new approach called adaptive Deep Brain Stimulation (aDBS) for adults with Spinocerebellar Ataxia Type 6 (SCA6). SCA6 is a condition that affects coordination and balance. The study will involve surgically implanting a device into a specific part of the brain called the interposed nucleus of the cerebellum. This device will deliver electrical stimulation and record brain activity. Researchers want to see if this treatment is safe, practical, and if it shows early signs of helping with SCA6 symptoms. They will also look for a specific brain signal that could help guide the aDBS treatment. To join, you must be diagnosed with SCA6, have a positive genetic test, and be able to walk with or without support. The study is currently unclear on its recruitment status and plans to enroll 5 participants.

Study design
This is a single-center, open-label study, meaning both you and the researchers will know what treatment you are receiving. It will involve 5 participants.
What's involved
You will have up to 18 in-person study visits over a 24-month (2-year) period. These visits will involve recording brain signals during different tasks and stimulation conditions.
Compensation
Not stated in the trial record.
Follow-up
Your safety and the identification of a physiological signal will be monitored from the beginning of the study through its completion, which is about 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07325487

Interposed Nucleus aDBS for Ataxia

Recruiting
NAAges 21–89InterventionalTreatment
University of Florida
~5 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Deep Brain Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The identification of a physiological signal to use as the aDBS feedback signal
Measured over From baseline through study completion, about 2 years.
+1 more outcome measured

Conditions

Spinocerebellar Ataxia (SCA)
Spinocerebellar Ataxia Type 6

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NCT07325487

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Norman Fixel Institute for Neurological Diseases

    Gainesville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Coralie de Hemptinne, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Julia C Gonzalez, BA
[email protected]
(352) 265-0111 · ext. 32495
Email the study team

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Eligibility criteria

Inclusion

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

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 personality disorder at the discretion of the study team
Coagulopathy, uncontrolled epilepsy, or other medical conditions that are considered to place the patient at elevated risk for surgical complications
Presence of a concomitant medical condition that, in the investigator's opinion, may interfere with the study participation or gait/balance, for example, severe arthritis
Requirement of diathermy, electroconvulsive therapy, or transcranial magnetic stimulation
Pregnancy or lactation
Active suicidal ideation, defined as fined as a "Yes" response to questions #2-5 within the past one month on the Columbia Suicide Severity Rating Scale, C-SSRS
Refractory epilepsy

What this trial measures

  • The identification of a physiological signal to use as the aDBS feedback signalFrom baseline through study completion, about 2 years.

    Local field potentials (LFP) will be recorded in the clinic as well as chronically at home. These recordings will be analyzed to identify electrophysiological markers of disease states and therapeutic effects.

  • The incidence of unexpected adverse events and serious adverse events with aDBS compared to baselineFrom baseline through study completion, about 2 years.

    Adverse events are monitored the entire time subject is enrolled in study. Unexpected and serious adverse events from baseline through study completion, about 2 years, is a primary endpoint.