ClinicalTrials.gg
RecruitingNCT07288437Updated Jul 13, 2026

Deep Brain Stimulation for Spinocerebellar Ataxia

An interventional study of Deep Brain Stimulation (DBS) in Spinocerebellar Ataxia (SCA) and Spinocerebellar Ataxia Type 6, sponsored by University of California, San Francisco. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
21 Years to 89 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 36 studies in Spinocerebellar Ataxias with a site in United States — 7 open to participants now, 14 under way, 2 of them phase 3. Spinocerebellar Ataxias · United States.

Planned enrollment
18th of 22
5 · median 20
Started
2026
with 5 others
No phase
13 of 36
4 open now
Primary completion
2029-03
later than 9 of 13 live
Registered
32nd of 36
by date

Among the 36 studies in Spinocerebellar Ataxias with a site in United States, this one is the 18th largest by planned enrollment of the 22 interventional ones that give a count, is one of 6 that started in 2026, is one of 13 with no phase, reaches primary completion later than 9 of the 13 other live ones, and was the 32nd registered.

Spinocerebellar Ataxias

95 studies on the registry are indexed under Spinocerebellar Ataxias; 25 are open to participants now.

Browse Spinocerebellar Ataxias studies →

Open to participants now

7 of the 36 studies in Spinocerebellar Ataxias with a site in United States are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 16 Spinocerebellar Ataxias studies recruiting now, 8 (50%) set no upper age limit and 3 (19%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 21 Years to 89 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 36 studies in Spinocerebellar Ataxias with a site in United States, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Spinocerebellar Ataxia (SCA)
  • Spinocerebellar Ataxia Type 6

Keywords

  • adaptive deep brain stimulation
  • aDBS
  • Spinocerebellar Ataxia
  • Spinocerebellar Ataxia Type 6
  • SCA6
  • DBS
  • deep brain stimulation
04

Who can participate

Ages eligible
21 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for the study.
  7. Be able to understand the study protocol.

Exclusion criteria

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 (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, 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. Epilepsy.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Adaptive Deep Brain Stimulation (aDBS)

    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.

    Device: Deep Brain Stimulation (DBS)

Interventions

  • DeviceDeep Brain Stimulation (DBS)

    This device will be surgically implanted into the dentate nucleus of the cerebellum.

    Also known as: Medtronic Percept

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline through study completion, about 2 years.

  2. 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.

    Time frame: From baseline through study completion, about 2 years.

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Mar 2029, 35 months after the start.

Of 28 interventional studies with no phase under Spinocerebellar Ataxias, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2025
First posted
Dec 17, 2025
StartActual
Apr 27, 2026
Primary completionEst.
Mar 2029
CompletionEst.
Mar 2031
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07288437
Collaborators
Raynor Cerebellum Project
Responsible party
Marta San Luciano Palenzuela, MD (Professor of Neurology, University of California, San Francisco) — Principal investigator
First posted
Dec 17, 2025
Start date
Apr 27, 2026
Primary completion
Mar 2029 (estimated)
Completion
Mar 2031 (estimated)
Last update
Jul 13, 2026

Study contacts

Marta San Luciano Palenzuela, MD, PhD
Contact
Marta.SanLucianoPalenzuela@ucsf.edu
(415) 353-2311
Karson J Franjieh, BS
Contact
karson.franjieh@ucsf.edu
415-755-8954
Marta San Luciano Palenzuela, MD, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion