Brain implant that learns could help rare movement disorder
NCT ID NCT07325487
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 4 times
Summary
This early study tests whether a smart brain implant can help people with spinocerebellar ataxia type 6, a condition that causes trouble with balance and coordination. Five adults will get the implant, which records brain signals and adjusts stimulation automatically. The goal is to see if it is safe and if it can improve walking and daily movement.
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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 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2031
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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21 to 89 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: * 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
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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
1 site. 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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Norman Fixel Institute for Neurological Diseases
RECRUITINGGainesville, Florida, 32608, United States
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