[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07288437":3,"trial-entities:NCT07288437":94,"trial-summary:NCT07288437":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":44,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":83,"overall_officials":89,"references":92,"see_also_links":93},"NCT07288437","25-44582","Deep Brain Stimulation for Spinocerebellar Ataxia","Adaptive Deep Brain Stimulation Targeting the Dentate Nucleus to Treat Spinocerebellar Ataxia","RECRUITING","2031-03","2025-12","2026-07-13","2026-04-27","University of California, San Francisco","OTHER",true,"The goal of this clinical trial is to test the safety of placing Deep Brain Stimulators (DBS) in the cerebellum and using electrical stimulation of that part of the brain to treat symptoms related to the participants spinocerebellar ataxia. Five adults diagnosed with spinocerebellar ataxia type 6 (SCA6) with inadequate cerebellar symptom relief will be implanted with a Medtronic Percept Primary Cell Neurostimulator. The device will be implanted into the dentate nucleus, which is a structure located within the cerebellum that is responsible for controlling movement and balance.\n\nSpecifically, the investigators will be using adaptive deep brain stimulation (aDBS), which analyzes brain signals and automatically adjusts the strength, timing, and pattern of stimulation according to the patient's needs at any given moment. This study will evaluate the feasibility, safety, and tolerability of aDBS in SCA6 patients.",null,[19,20],"Spinocerebellar Ataxia (SCA)","Spinocerebellar Ataxia Type 6",[22,23,24,20,25,26,27],"adaptive deep brain stimulation","aDBS","Spinocerebellar Ataxia","SCA6","DBS","deep brain stimulation","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},5,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"DEVICE","Deep Brain Stimulation (DBS)","This device will be surgically implanted into the dentate nucleus of the cerebellum.",[41],"Adaptive Deep Brain Stimulation (aDBS)",[43],"Medtronic Percept",[45,49],{"measure":46,"description":47,"timeFrame":48},"Average total score for the Assessment and Rating of Ataxia (SARA)","SARA is a clinical scale that assesses a variety of different impairments for individuals with cerebellar ataxia. The scale includes 8 different items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test. The total amount of points on SARA ranges from 0 (no ataxia) to 40 (most severe ataxia). This study requires participants to have a minimum SARA score of at least 8 so that people who are relatively early in their disease course with limited cerebellar degeneration can be included.","From baseline through study completion, about 2 years.",{"measure":50,"description":51,"timeFrame":48},"Average total Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia) Score","PROM-Ataxia is a 3-domain, 70-item questionnaire used for the assessment of ataxia-related symptoms. It incorporates a series of questions ranging to the impact of cerebellar dysfunction on physical abilities, activities of daily living, and cognitive-emotional challenges. The maximum severity score on PROM-Ataxia is 280, where all 70 questions are scored on a 0-4 Likert scale. 0 represents never and 4 represents always.",[],"ALL","21 Years","89 Years",false,{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Inclusion Criteria:\n\n1. A diagnosis of SCA6 by a Movement Disorders specialist following established criteria recommended by the Movement Disorders Society.\n2. A positive genetic test for SCA6.\n3. A total scale ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) rating scale.\n4. Ability to walk with or without support (score \\\u003C 8 on the 'gait' subsection of the SARA rating scale).\n5. Age ≥ 21 years and \\\u003C 89 years.\n6. Ability to give informed consent for the study.\n7. Be able to understand the study protocol.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to comply with the study protocol.\n2. History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants.\n3. Severe cognitive impairment or dementia, defined as a score \\\u003C 21 on the Montreal Cognitive Assessment (MoCA).\n4. Evidence of ataxia due to other etiologies, including but not limited to:\n\n   1. Genetic\u002Finherited disorders other than SCA6.\n   2. Acquired causes: tramautic brain injury, multiple sclerosis, paraneplastic cerebellar degeneration, infections or post-infectious cerebellitis, autoimmune ataxias (e.g., anti-GAD, gluten ataxia).\n   3. Toxic\u002Fmetabolic causes: alcoholic cerebellar degeneration, vitamin deficiencies.\n   4. Structural, vascular, or neoplastic causes: cerebellar stroke, tumors, congenital malformations.\n   5. Suspected multiple system atrophy-cerebellar type (MSA-C).\n5. The presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or personality disorder at the discretion of the study team.\n6. Coagulopathy, uncontrolled epilepsy, or other medical condition 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\u002Fbalance, for example, severe arthritis.\n7. Presence of a concominant medical condition that, in the investigator's opinion, may interfere with the study participation or gait\u002Fbalance, for example, severe arthritis.\n8. Requirement of diathermy, electroconvulsive therapy, or transcranial magnetic stimulation.\n9. Pregnancy or lactation.\n10. Active suicidal ideation, defined as fined as a \"Yes\" response to questions #2-5 on the Columbia Suicide Severity Rating Scale, C-SSRS.\n11. Refractory Epilepsy.",[62,63],"ADULT","OLDER_ADULT",[65,74],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"UCSF Weill Institute for Neurosciences","San Francisco","California","94158","United States",{"lat":72,"lon":73},37.77493,-122.41942,{"facility":13,"status":75,"city":67,"state":68,"zip":69,"country":70,"contacts":76,"geoPoint":82},"NOT_YET_RECRUITING",[77],{"name":78,"role":79,"phone":80,"email":81},"Marta San Luciano Palenzuela, MD, PhD","CONTACT","(415) 353-2311","Marta.SanLucianoPalenzuela@ucsf.edu",{"lat":72,"lon":73},[84,85],{"name":78,"role":79,"phone":80,"email":81},{"name":86,"role":79,"phone":87,"email":88},"Karson J Franjieh, BS","415-755-8954","karson.franjieh@ucsf.edu",[90],{"name":78,"affiliation":13,"role":91},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":96},[20],[97],"CACNA1A wt Allele",{"nct_id":4,"found":15,"summary":99,"prompt_version":17},{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an interventional study involving 5 participants with Spinocerebellar Ataxia Type 6 (SCA6). It is not specified if the study is randomized or blinded.","completed","Deep Brain Stimulation for Spinocerebellar Ataxia Type 6","This study is testing the safety of Deep Brain Stimulation (DBS) for people with Spinocerebellar Ataxia Type 6 (SCA6). DBS involves surgically placing a device in a part of the brain called the cerebellum to use electrical stimulation to help with ataxia symptoms. We are looking for 5 adults, aged 21 to 89, who have a confirmed diagnosis of SCA6, a positive genetic test, and certain levels of ataxia symptoms. The main goals are to see how much your ataxia symptoms improve, measured by the SARA and PROM-Ataxia scores, over about two years. This study is currently unclear on its recruitment status.","Participants will be followed for about two years after the start of the study.",102,"Participants will undergo surgery to implant a Deep Brain Stimulator device. Your ataxia symptoms will be measured from before the surgery through about two years after.","Not stated in the trial record.",[38]]