Interposed Nucleus aDBS for Ataxia in SCA6

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label study will enroll up to 5 adults with SCA6 to test the feasibility, safety, and early signs of efficacy of adaptive deep brain stimulation targeting the cerebellar interposed nucleus. Participants will have DBS leads implanted in the interposed nucleus and may receive one or two implanted pulse generators to deliver stimulation and record neural activity. The study includes up to 18 in-person visits over 24 months to identify stimulation settings and neural biomarkers that guide adaptive DBS. Initial visits focus on parameter optimization and biomarker discovery, with later periods applying adaptive stimulation based on the biomarkers. The trial is designed to provide preliminary data on whether aDBS can modulate symptoms in SCA6.

Why it matters

Who can join: the full rules

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

Where it's running

• Norman Fixel Institute for Neurological Diseases
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Coralie de Hemptinne, PhD — University of Florida
• Study coordinator: Julia C Gonzalez, BA
• Email: Julia.Gonzalez@neurology.ufl.edu
• Phone: (352) 265-0111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This will see if an implanted adaptive deep brain stimulator placed in the cerebellum can reduce movement and balance problems in adults with SCA6 who still have symptoms.

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• Natural history and genetic modifiers in spinocerebellar ataxias

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  Recruiting at 15 sites National Ataxia Foundation · Los Angeles, California and 16 other locations · NCT01060371

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.