Can brain stimulation tame ataxia?
NCT ID NCT07752095
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial tests whether deep brain stimulation (DBS) targeting the cerebellum is safe and feasible for people with spinocerebellar ataxia types 1 and 3, a group of inherited disorders that cause progressive problems with movement and coordination. The study will enroll 12 adults with moderate ataxia and will measure side effects, as well as changes in ataxia severity and brain activity. The goal is to see if this approach could offer a new way to control symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Deep brain stimulation (DBS) of the deep cerebellar nuclei using the UG3NS140720 system
- What this could lead to
- If successful, this could lead to a new treatment option to improve movement and coordination in people with spinocerebellar ataxia.
- What could go wrong
- This is an early safety and feasibility study with a small number of participants. Risks include bleeding in the brain, infection, and device-related complications. The treatment may not improve symptoms.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject is aged \>= 18 years and =\< 60 years. * Subject has moderate ataxia severity, as demonstrated by a Scale for Ataxia Rating and Assessment (SARA) score \>= 11. * Subject has genetic confirmation of pathological repeat expansions in ATXN1 (for SCA1, repeat size \>= 40) and ATXN3 (for SCA3, repeat size \>= 56). * Subject has been on a stable and optimized standard of care (SoC) regimen for at least 3 months prior to Screening (including physical therapy) and continues to exhibit signs of cerebellar ataxia. * Subject has a minimum 6th grade reading level, as determined by the Rapid Estimate of Adult Literacy in Medicine (REALM) scale. * Subject is able and willing to give informed consent and attend all study visits. * Subject is available for all follow-up visits during the length of the study. Exclusion Criteria: * Subject is unable to provide informed consent. * Subject has presence of overt tremor, dystonia, and/or parkinsonism, which are atypical features and could be suggestive of prominent extra-cerebellar circuit involvement that may not respond well to cerebellar DBS. * Subject is wheelchair dependent and may be too progressed to complete gait assessments. * Subject is unable to stop anticoagulation or platelet anti-aggregation therapy for study procedures. * Subject has a Montreal Cognitive Assessment (MoCA) score =\< 24. * Subject has a diagnosis of epilepsy. * Subject has a major active psychiatric illness that may interfere with the study, such as psychiatric disorders or severe personality disorders. * Subject has an untreated or inadequately treated major depressive episode. * Subject is pregnant, lactating, or planning to become pregnant during the study. * For women of childbearing potential, subject is unable or unwilling to use accepted contraception methods. * Subject is unable to communicate with investigators or staff. * Subject has contraindications to DN DBS, including significant small vessel ischemic disease, vertebrobasilar vascular disease, and/or any other structural abnormalities of the cerebellum, cerebellar peduncles, and brain stem that would preclude safe placement of the DBS leads. * Subject has contraindications to magnetic resonance (MR) imaging, e.g., weight incompatible with scanner, implanted metallic devices or electrical devices (pacemaker, defibrillator, spinal cord stimulator), or intolerance to MRI contrast agents. * Subject is enrolled in another device, biologic or pharmaceutical study within 30 days of consent in the current study (i.e., patients cannot be enrolled if participation in another study was not completed at least 30 days prior to consent). * Subject has evidence of behavior(s) consistent with alcohol or substance abuse/dependence within the preceding 6 months, as outlined by the DSM-V criteria. * Subject has a condition that, in the opinion of the investigator, would significantly increase the risk for interference with study compliance, safety, or outcome. * Subject is at risk for suicide, defined by a total score \>= 3 on the Columbia Suicide Severity Rating Scale (C-SSRS). * Patients who are not able to read, speak and/or understand English.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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