Who is eligible for clinical trial NCT07325487?

Participants must meet the protocol's inclusion criteria for Spinocerebellar Ataxia (SCA). The stated age range is 21 Years to 89 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07325487 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-17

Interposed Nucleus aDBS for Ataxia (NCT07325487)

Adaptive Deep Brain Stimulation Targeting the Interposed Nucleus to Treat Spinocerebellar Ataxia

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of Florida

🩺 Plain-English Summary (8th-Grade Level)

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. Participants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. The leads will be connected to one or two implantable pulse generators capable of delivering stimulation to deep brain structures and recording neural activity. Participants will complete up to 18 in-person study visits over a 24-month follow-up period. During these visits, neural signals will be recorded under varying behavioral tasks and stimulation conditions. Early study visits will be used to identify optimal stimulation parameters and neural biomarkers associated with disease state. These biomarkers will subsequently be used to implement adaptive DBS, in which stimulation amplitude is automatically adjusted in response to recorded neural activity. Study outcomes will include assessments of safety and feasibility of cerebellar aDBS, as well as preliminary evaluation of its effects on clinical measures.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (17 items).

Location: Norman Fixel Institute for Neurological Diseases — Gainesville, Florida

Age range: 21 Years to 89 Years

🧪 Interventions in This Study

Deep Brain Stimulation (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Norman Fixel Institute for Neurological Diseases — Gainesville, Florida

📞 Contact the Study Coordinator

Phone: (352) 265-0111

Email: Julia.Gonzalez@neurology.ufl.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Spinocerebellar Ataxia (SCA)

Deep Brain Stimulation for Spinocerebellar Ataxia — San Francisco, California

Explore by condition: All Spinocerebellar Ataxia (SCA) clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗