Spinocerebellar Ataxia (SCA)NCT07288437
Deep Brain Stimulation for Spinocerebellar Ataxia
A study testing Deep Brain Stimulation (DBS) in people with Spinocerebellar Ataxia (SCA) and Spinocerebellar Ataxia Type 6, run by University of California, San Francisco at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Spinocerebellar Ataxia (SCA), Spinocerebellar Ataxia Type 6
- What is being tested?
- Deep Brain Stimulation (DBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2026to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UCSF Weill Institute for Neurosciences
San Francisco, California, 94158
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94158
Marta San Luciano Palenzuela, MD, PhD, (415) 353-2311, Marta.SanLucianoPalenzuela@ucsf.edu
About this study
Official title: Adaptive Deep Brain Stimulation Targeting the Dentate Nucleus to Treat Spinocerebellar Ataxia
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.
- Being tested
- Deep Brain Stimulation (DBS)
- Keywords
- adaptive deep brain stimulation, aDBS, Spinocerebellar Ataxia, Spinocerebellar Ataxia Type 6, SCA6, DBS, deep brain stimulation
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (DBS)Device
Also called Medtronic Percept
This device will be surgically implanted into the dentate nucleus of the cerebellum.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Deep Brain Stimulation (aDBS) | Experimental | One month after patients undergo DBS surgery in the cerebellum, conventional deep brain stimulation (cDBS) programming will begin to identify stimulation parameters (such as amplitude, contact, frequency, and pulse width) and ensure no adverse wide effects are witness. This phase also allows the study team to make sure device and electrode placement are working as intended. About nine months after implantation, the investigators will switch system settings over to aDBS to evaluate the feasibility, safety, and tolerability in the dentate nucleus of the cerebellum. Symptoms and side effects will be assessed by patients' self-reports, validated clinical scales, and wearable devices, which will be used to track movements and sleep data. Receives: Device: Deep Brain Stimulation (DBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average total score for the Assessment and Rating of Ataxia (SARA)
SARA is a clinical scale that assesses a variety of different impairments for individuals with cerebellar ataxia. The scale includes 8 different items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test. The total amount of points on SARA ranges from 0 (no ataxia) to 40 (most severe ataxia). This study requires participants to have a minimum SARA score of at least 8 so that people who are relatively early in their disease course with limited cerebellar degeneration can be included.
Measured: From baseline through study completion, about 2 years.
Average total Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia) Score
PROM-Ataxia is a 3-domain, 70-item questionnaire used for the assessment of ataxia-related symptoms. It incorporates a series of questions ranging to the impact of cerebellar dysfunction on physical abilities, activities of daily living, and cognitive-emotional challenges. The maximum severity score on PROM-Ataxia is 280, where all 70 questions are scored on a 0-4 Likert scale. 0 represents never and 4 represents always.
Measured: From baseline through study completion, about 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start27 Apr 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar Ataxia (SCA)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Raynor Cerebellum Project
- Responsible party
- Principal investigator, Marta San Luciano Palenzuela, MD, University of California, San Francisco
- Investigators
- Marta San Luciano Palenzuela, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288437
- Sponsor's protocol ID
- 25-44582
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Deep Brain Stimulation Targeting the Dentate Nucleus to Treat Spinocerebellar Ataxia
- ClinicalTrials.gov ID
- NCT07288437
- Acronym / sponsor ID
- 25-44582
- Keywords
- adaptive deep brain stimulation, aDBS, Spinocerebellar Ataxia, Spinocerebellar Ataxia Type 6, SCA6, DBS, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Raynor Cerebellum Project
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Deep Brain Stimulation (aDBS) | Experimental | Device: Deep Brain Stimulation (DBS)One month after patients undergo DBS surgery in the cerebellum, conventional deep brain stimulation (cDBS) programming will begin to identify stimulation parameters (such as amplitude, contact, frequency, and pulse width) and ensure no adverse wide effects are witness. This phase also allows the study team to make sure device and electrode placement are working as intended. About nine months after implantation, the investigators will switch system settings over to aDBS to evaluate the feasibility, safety, and tolerability in the dentate nucleus of the cerebellum. Symptoms and side effects will be assessed by patients' self-reports, validated clinical scales, and wearable devices, which will be used to track movements and sleep data. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
- The presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or personality disorder at the discretion of the study team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation (DBS)Also: Medtronic PerceptThis device will be surgically implanted into the dentate nucleus of the cerebellum. | Device | Adaptive Deep Brain Stimulation (aDBS) |
Primary outcome
Average total score for the Assessment and Rating of Ataxia (SARA)
Time frame: From baseline through study completion, about 2 years.
SARA is a clinical scale that assesses a variety of different impairments for individuals with cerebellar ataxia. The scale includes 8 different items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test. The total amount of points on SARA ranges from 0 (no ataxia) to 40 (most severe ataxia). This study requires participants to have a minimum SARA score of at least 8 so that people who are relatively early in their disease course with limited cerebellar degeneration can be included.
Average total Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia) Score
Time frame: From baseline through study completion, about 2 years.
PROM-Ataxia is a 3-domain, 70-item questionnaire used for the assessment of ataxia-related symptoms. It incorporates a series of questions ranging to the impact of cerebellar dysfunction on physical abilities, activities of daily living, and cognitive-emotional challenges. The maximum severity score on PROM-Ataxia is 280, where all 70 questions are scored on a 0-4 Likert scale. 0 represents never and 4 represents always.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Spinocerebellar Ataxia (SCA)
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Natural History Study of and Genetic Modifiers in Spinocerebellar Ataxias
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta San Luciano Palenzuela, MD, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation (DBS) in people with Spinocerebellar Ataxia (SCA) and Spinocerebellar Ataxia Type 6, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta San Luciano Palenzuela, MD, PhD ((415) 353-2311, Marta.SanLucianoPalenzuela@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average total score for the Assessment and Rating of Ataxia (SARA) (time frame: From baseline through study completion, about 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.