Who may be eligible for the Deep Brain Stimulation for Spinocerebellar Ataxia trial?

Inclusion Criteria: 1. A diagnosis of SCA6 by a Movement Disorders specialist following established criteria recommended by the Movement Disorders Society. 2. A positive genetic test for SCA6. 3. A total scale ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) rating scale. 4. Ability to walk with or without support (score \< 8 on the 'gait' subsection of the SARA rating scale). 5. Age ≥ 21 years and \< 89 years. 6. Ability to give informed consent for the study. 7. Be able to understand the study protocol. Exclusion Criteria: 1. Inability or unwillingness to comply with the study protocol. 2. History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants. 3. Severe cognitive impairment or dementia, defined as a score \< 21 on the Montreal Cognitive Assessment (MoCA). 4. Evidence of ataxia due to other etiologies, including but not limited to: 1. Genetic/inherited disorders other than SCA6. 2. Acquired causes: tramautic brain injury, multiple sclerosis, paraneplastic cerebellar degeneration, infections or post-infectious cerebellitis, autoimmune ataxias (e.g., anti-GAD, gluten ataxia). 3. Toxic/metabolic causes: alcoholic cerebellar degeneration, vitamin deficiencies. 4. Structural, vascular, or neoplastic causes: cerebellar stroke, tumors, congenital malformations. 5. Suspected multiple system atrophy-cerebellar type (MSA-C). 5. The presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or personality disorder at the discretion of the study team. 6. Coagulopathy, uncontrolled epilepsy, or other medical condition 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. 7. Presence of a concominant medical condition that, in the investigator's opinion, may interfere with the study participation or gait/balance, for example, severe arthritis. 8. Requirement of diathermy, electroconvulsive therapy, or transcranial magnetic stimulation. 9. Pregnancy or lactation. 10. Active suicidal ideation, defined as fined as a "Yes" response to questions #2-5 on the Columbia Suicide Severity Rating Scale, C-SSRS. 11. Refractory Epilepsy.

ClinicalTrials.gov record NCT07288437

Deep Brain Stimulation for Spinocerebellar Ataxia

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

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

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.

This interventional study tests placing a deep brain stimulation (DBS) device into the dentate nucleus of the cerebellum and using adaptive DBS (aDBS) in adults with genetically confirmed SCA6. Five adults will be implanted with a Medtronic Percept device; conventional programming begins about one month after surgery and settings switch to aDBS around nine months. Symptoms and side effects will be followed for about two years using clinical scales, patient reports, and wearable devices. The study evaluates feasibility, safety, and tolerability.

What it is studying. The study is testing the feasibility, safety, and tolerability of implanting a DBS device in the dentate nucleus and using adaptive stimulation (aDBS) to address symptoms related to SCA6.

What the researchers hope to learn. To collect data on the feasibility, safety, and tolerability of adaptive DBS (aDBS) in the dentate nucleus for people with SCA6 and to record clinical and patient-reported ataxia outcome measures (SARA, PROM-Ataxia) and movement/sleep data over about two years.

What this study is about

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

The goal of this clinical trial is to test the safety of placing Deep Brain Stimulators (DBS) in the cerebellum and using electrical stimulation of that part of the brain to treat symptoms related to the participants spinocerebellar ataxia. Five adults diagnosed with spinocerebellar ataxia type 6 (SCA6) with inadequate cerebellar symptom relief will be implanted with a Medtronic Percept Primary Cell Neurostimulator. The device will be implanted into the dentate nucleus, which is a structure located within the cerebellum that is responsible for controlling movement and balance. Specifically, the investigators will be using adaptive deep brain stimulation (aDBS), which analyzes brain signals and automatically adjusts the strength, timing, and pattern of stimulation according to the patient's needs at any given moment. This study will evaluate the feasibility, safety, and tolerability of aDBS in SCA6 patients.

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 (DBS)

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 scale ≥ 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.
Be able 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: tramautic brain injury, multiple sclerosis, paraneplastic 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).
The 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 condition 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.
Presence of a concominant 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 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 undergo brain surgery to have a Medtronic Percept neurostimulator implanted in the dentate nucleus of the cerebellum. About one month after surgery there will be visits for conventional DBS programming to set stimulation parameters; about nine months after implantation the system settings will be switched to adaptive DBS (aDBS). Symptoms and side effects will be tracked with patient questionnaires and clinical scales (for example SARA and PROM-Ataxia) and with wearable devices that record movement and sleep; follow-up assessments continue through study completion (about 2 years).

How the study is structured. Interventional, single-group study with no masking. Participants receive surgical implantation of a Medtronic Percept DBS device in the dentate nucleus. About one month after surgery conventional DBS programming will be used to set parameters; about nine months after implantation the system will be switched to adaptive DBS. Participants are followed with clinical scales (including SARA), a patient-reported ataxia questionnaire (PROM-Ataxia), self-reports, and wearable movement/sleep monitoring over roughly two years.

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: Apr 27, 2026
Primary completion: March 2029 (estimated)
Study completion: March 2031 (estimated)
Target enrollment: 5 participants (estimated)
Last updated on registry: Jul 13, 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 California, San Francisco
Principal investigator: Marta San Luciano Palenzuela, MD, Professor of Neurology
University of California, San Francisco
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.

Marta San Luciano Palenzuela, MD, PhD 📞 (415) 353-2311 ✉ Marta.SanLucianoPalenzuela@ucsf.edu
Karson J Franjieh, BS 📞 415-755-8954 ✉ karson.franjieh@ucsf.edu

Participating sites (2)

UCSF Weill Institute for NeurosciencesRecruiting
San Francisco, California, 94158 · United States
University of California, San FranciscoNot Yet Recruiting
San Francisco, California, 94158 · United States
- Marta San Luciano Palenzuela, MD, PhD · (415) 353-2311 · Marta.SanLucianoPalenzuela@ucsf.edu

Terms used on this page · explanations by MedicalUpdates.ai

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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