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New treatment option for Spinocerebellar Ataxia (SCA)
Official title Interposed Nucleus aDBS for Ataxia
ClinicalTrials.gov ID: NCT07325487
What this study is testing
- What it's testing
- This is a single-center, open-label study designed to evaluate the feasibility, safety, and preliminary efficacy of cerebellar adaptive deep brain stimulation (aDBS) in adults with spinocerebellar ataxia type 6 (SCA6). A total of 5 participants will be enrolled.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 89
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.