ClinicalTrials.gov record NCT07325487

Interposed Nucleus aDBS for Ataxia

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age21 years old to 89 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A single-group, open-label study testing cerebellar adaptive deep brain stimulation (aDBS) in adults with SCA6. Five participants will have DBS leads implanted in the motor interposed nucleus and receive conventional then adaptive stimulation with neural recording. Participants are followed with clinic visits and at-home recordings over about 24 months to assess feasibility, safety, and preliminary clinical effects.

What it is studying. Whether it is feasible and safe to record cerebellar neural signals and use them to automatically adjust deep brain stimulation (adaptive DBS) in people with SCA6, and whether those recordings can identify physiological markers tied to disease state and stimulation effects.

What the researchers hope to learn. Identify electrophysiological signals usable as feedback for adaptive DBS; evaluate feasibility, safety, and tolerability of cerebellar aDBS; and collect preliminary data on balance, ataxia severity, and patient-reported ataxia outcomes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Deep Brain Stimulation

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have surgery to implant deep brain stimulation (DBS) leads into the cerebellar interposed nucleus and one or two implantable pulse generators. About one month after surgery they will begin conventional DBS programming; around nine months the device will be switched to adaptive DBS that automatically adjusts stimulation based on recorded brain signals. Neural signals will be recorded in clinic and chronically at home, and participants will attend up to 18 in-person visits over a 24-month follow-up for programming, clinical scales and questionnaires, wearable movement/sleep monitoring, and safety monitoring for adverse events.

How the study is structured. Interventional device study with one treatment group and no masking. Participants undergo surgical implantation of DBS leads in the cerebellar interposed nucleus, begin conventional DBS programming about one month later, and transition to adaptive DBS around nine months. Neural signals will be recorded in clinic and chronically at home; up to 18 in-person visits occur across a roughly 24-month follow-up. The study enrolls five participants.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on spinocerebellar ataxia

Clinical trials30 trials listed for spinocerebellar ataxiaEvery trial the registry lists for spinocerebellar ataxia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in spinocerebellar ataxia researchLatest monthly update: September 2026. Includes: NBP trial result. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 2, 2026
Primary completion
June 2031 (estimated)
Study completion
June 2031 (estimated)
Target enrollment
5 participants (estimated)
Last updated on registry
Jul 20, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Florida
Collaborators
  • Raynor Cerebellum Project

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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