Phase
Condition
Friedreich's Ataxia
Spinocerebellar Disorders
Treatment
Deep Brain Stimulation (DBS)
Clinical Study ID
Ages 21-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A diagnosis of SCA6 by a Movement Disorders specialist following establishedcriteria recommended by the Movement Disorders Society.
A positive genetic test for SCA6.
A total scale ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) ratingscale.
Ability to walk with or without support (score < 8 on the 'gait' subsection of theSARA rating scale).
Age ≥ 21 years and < 89 years.
Ability to give informed consent for the study.
Be able to understand the study protocol.
Exclusion
Exclusion Criteria:
Inability or unwillingness to comply with the study protocol.
History of previously implanted neurostimulators, pacemakers, defibrillators, ormetallic head implants.
Severe cognitive impairment or dementia, defined as a score < 21 on the MontrealCognitive Assessment (MoCA).
Evidence of ataxia due to other etiologies, including but not limited to:
Genetic/inherited disorders other than SCA6.
Acquired causes: tramautic brain injury, multiple sclerosis, paraneplasticcerebellar degeneration, infections or post-infectious cerebellitis, autoimmuneataxias (e.g., anti-GAD, gluten ataxia).
Toxic/metabolic causes: alcoholic cerebellar degeneration, vitamindeficiencies.
Structural, vascular, or neoplastic causes: cerebellar stroke, tumors,congenital malformations.
Suspected multiple system atrophy-cerebellar type (MSA-C).
The presence of active and untreated psychiatric illness, severe depression (BeckDepression Inventory ≥ 21), or personality disorder at the discretion of the studyteam.
Coagulopathy, uncontrolled epilepsy, or other medical condition considered to placethe patient at elevated risk for surgical complications. Presence of a concomitantmedical condition that, in the investigator's opinion, may interfere with the studyparticipation or gait/balance, for example, severe arthritis.
Presence of a concominant medical condition that, in the investigator's opinion, mayinterfere with the study participation or gait/balance, for example, severearthritis.
Requirement of diathermy, electroconvulsive therapy, or transcranial magneticstimulation.
Pregnancy or lactation.
Active suicidal ideation, defined as fined as a "Yes" response to questions #2-5 onthe Columbia Suicide Severity Rating Scale, C-SSRS.
Refractory Epilepsy.
Study Design
Connect with a study center
UCSF Weill Institute for Neurosciences
San Francisco, California 94158
United StatesActive - Recruiting
University of California, San Francisco
San Francisco, California 94158
United StatesSite Not Available
University of California, San Francisco
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available

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