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NCT Number: NCT07325487

Interposed Nucleus aDBS for Ataxia

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.

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Key information

Conditions

Spinocerebellar Ataxia (SCA) Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Spinal Cord Diseases Spinocerebellar Ataxia Type 6 Spinocerebellar Ataxias Spinocerebellar Degenerations

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location status: Recruiting

Location contact

Coralie de Hemptinne, PhD

PRINCIPAL_INVESTIGATOR

Emily Rafferty, PhD

CONTACT

[email protected]

Julia C Gonzalez, BA

CONTACT

[email protected]

352-265-0111 ext. 32495

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

This device will be surgically implanted into the interposed nucleus of the cerebellum.

Other names: Medtronic Percept

Primary outcomes

  1. The identification of a physiological signal to use as the aDBS feedback signal

    Time frame: From baseline through study completion, about 2 years.

    Local field potentials (LFP) will be recorded in the clinic as well as chronically at home. These recordings will be analyzed to identify electrophysiological markers of disease states and therapeutic effects.

  2. The incidence of unexpected adverse events and serious adverse events with aDBS compared to baseline

    Time frame: From baseline through study completion, about 2 years.

    Adverse events are monitored the entire time subject is enrolled in study. Unexpected and serious adverse events from baseline through study completion, about 2 years, is a primary endpoint.

Secondary outcomes

  1. The Upright Balance Assessment measured by force plate parameters

    Time frame: From baseline through study completion, about 2 years.

    The Upright Balance Assessment is designed to evaluate walking and balance.

  2. The Scale for the Assessment and Rating of Ataxia (SARA)

    Time frame: From baseline through study completion, about 2 years.

    The Scale for the Assessment and Rating of Ataxia (SARA) is an 8-item performance based scale used to determine the severity of ataxia. Scoring ranges from 0 to 40, with a higher score indicating greater ataxia severity.

  3. The Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia)

    Time frame: From baseline through study completion, about 2 years.

    The Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia) is a 70-item scale divided into three domains of patient experiences assessing physical function, activities of daily living (ADL), and mental health. Scores range from 0 to 280, with a higher score indicating more severe symptoms and poorer quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Rafferty, PhD

CONTACT

[email protected]

Julia C Gonzalez, BA

CONTACT

[email protected]

(352) 265-0111 ext. 32495

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Raynor Cerebellum Project

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jan 8, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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