[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05701280":3,"trial-entities:NCT05701280":227,"trial-summary:NCT05701280":231},{"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":46,"secondary_outcomes":51,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":65,"locations":68,"central_contacts":223,"overall_officials":224,"references":225,"see_also_links":226},"NCT05701280","REDD 0084","Pilot\u002FPivotal Study of DBS+Rehab After Stroke","Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study","RECRUITING","2030-06","2026-01","2026-07-20","2023-02-03","Enspire DBS Therapy, Inc.","INDUSTRY",true,"The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.","The RESTORE Stroke Study combines two phases of study under one protocol (pilot\u002Fpivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase.\n\nEach subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.",[19,20],"Stroke","Upper Extremity Paresis",[22,23,24,25,26,27],"Ischemic Stroke","Deep Brain Stimulation","DBS","Physical Therapy","Rehabilitation","Brain Stimulation","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},202,"ESTIMATED",[36,41],{"type":37,"name":23,"description":38,"armGroupLabels":39},"DEVICE","Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.",[40],"DBS+Rehab",{"type":42,"name":26,"description":43,"armGroupLabels":44},"OTHER","Motor rehabilitation to improve upper-extremity function.",[45],"Rehab",[47],{"measure":48,"description":49,"timeFrame":50},"Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)","The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).","Week-12 to Week-32",[52],{"measure":48,"description":53,"timeFrame":50},"The change in FMA-UE for subjects who receive Test treatment (Tt) is significantly above a clinically important difference (CID)","ALL","21 Years",null,false,{"inclusion":59,"exclusion":61,"raw_text":64},[60],"Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.",[62,63],"Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment","Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus","Key Inclusion Criteria:\n\n* Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.\n\nKey Exclusion Criteria:\n\n* Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment\n* Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus",[66,67],"ADULT","OLDER_ADULT",[69,87,102,121,136,151,169,184,199,214],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"Barrow Neurological Institute (BNI)","Phoenix","Arizona","85013","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Markey Olson, PhD","CONTACT","602-406-6055","neuromodulationresearch@commonspirit.org",{"name":82,"role":83},"Francisco Ponce, MD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},33.44838,-112.07404,{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":74,"contacts":92,"geoPoint":99},"Mayo Clinic Florida","Jacksonville","Florida","32224",[93,97],{"name":94,"role":78,"phone":95,"email":96},"Amber Patchell","904-953-4711","Patchell.Amber@mayo.edu",{"name":98,"role":83},"Sanjeet Grewal, MD",{"lat":100,"lon":101},30.33218,-81.65565,{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":74,"contacts":107,"geoPoint":118},"Johns Hopkins School of Medicine","Baltimore","Maryland","21218",[108,112,116],{"name":109,"role":78,"phone":110,"email":111},"Robert Nickl, PhD","410-955-1347","rnickl1@jh.edu",{"name":113,"role":78,"phone":114,"email":115},"Jessica Wollet","667-306-8141","jwollet1@jhu.edu",{"name":117,"role":83},"William Anderson, MD, PhD",{"lat":119,"lon":120},39.29038,-76.61219,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":74,"contacts":126,"geoPoint":133},"Massachusetts General Hospital","Boston","Massachusetts","02114",[127,131],{"name":128,"role":78,"phone":129,"email":130},"Erin Donahue, PhD","617-643-3732","ekdonahue@mgh.harvard.edu",{"name":132,"role":83},"R. Mark Richardson, MD, PhD",{"lat":134,"lon":135},42.35843,-71.05977,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":74,"contacts":141,"geoPoint":148},"Mayo Clinic","Rochester","Minnesota","55906",[142,146],{"name":143,"role":78,"phone":144,"email":145},"Olyvia Heaser","507-538-6563","Heaser.Olyvia@mayo.edu",{"name":147,"role":83},"Rushna Ali, MD",{"lat":149,"lon":150},44.02163,-92.4699,{"facility":152,"status":8,"city":153,"state":153,"zip":154,"country":74,"contacts":155,"geoPoint":166},"NYU Langone Health","New York","10016",[156,160,164],{"name":157,"role":78,"phone":158,"email":159},"Cathryn Lapierre","6465012762","cathryn.lapierre@nyulangone.org",{"name":161,"role":78,"phone":162,"email":163},"Ava Paul","212-263-2314","Ava.Paul@nyulangone.org",{"name":165,"role":83},"Alon Mogilner, MD, PhD",{"lat":167,"lon":168},40.71427,-74.00597,{"facility":170,"status":8,"city":171,"state":172,"zip":173,"country":74,"contacts":174,"geoPoint":181},"Cleveland Clinic","Cleveland","Ohio","44195",[175,179],{"name":176,"role":78,"phone":177,"email":178},"Karen Stevenson","216-445-0926","STEVENK12@ccf.org",{"name":180,"role":83},"Andre Machado, MD, PhD",{"lat":182,"lon":183},41.4995,-81.69541,{"facility":185,"status":8,"city":186,"state":187,"zip":188,"country":74,"contacts":189,"geoPoint":196},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",[190,194],{"name":191,"role":78,"phone":192,"email":193},"Neurosurgery Research Department","215-503-4852","neurosurgeryresearch@jefferson.edu",{"name":195,"role":83},"Chengyuan Wu, MD",{"lat":197,"lon":198},39.95238,-75.16362,{"facility":200,"status":8,"city":201,"state":202,"zip":203,"country":74,"contacts":204,"geoPoint":211},"Rhode Island Hospital","Providence","Rhode Island","02903",[205,209],{"name":206,"role":78,"phone":207,"email":208},"Amanda Hasbrouck","401-444-6682","ahasbrouck@lifespan.org",{"name":210,"role":83},"Wael Asaad, MD, PhD",{"lat":212,"lon":213},41.82399,-71.41283,{"facility":215,"status":216,"city":217,"state":218,"zip":219,"country":74,"geoPoint":220},"Medical University of South Carolina (MUSC)","TERMINATED","Charleston","South Carolina","29425",{"lat":221,"lon":222},32.77632,-79.93275,[],[],[],[],{"nct_id":4,"conditions":228,"biomarkers":230},[22,229],"Monoparesis of upper limb",[],{"nct_id":4,"found":15,"summary":232,"prompt_version":242},{"design":233,"status":234,"heading":235,"summary":236,"follow_up":237,"word_count":238,"commitments":239,"compensation":240,"drugs_mentioned":241},"This is an interventional study with two phases, planning for 202 participants. It involves implanting a DBS system, then randomizing participants to either the test treatment or an active-control treatment.","completed","DBS+Rehab for Arm Weakness After Stroke","The RESTORE Stroke Study is testing a treatment called Deep Brain Stimulation (DBS) combined with motor rehabilitation to improve arm weakness and function after a stroke. You might be able to join if you had an ischemic stroke (a stroke caused by a blood clot) between 12 months and 6 years ago, and still have arm weakness. The study will measure success by looking at changes in your arm function using a tool called the Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) between 12 and 32 weeks. The current status of this study is unclear, but it plans to enroll 202 participants.","Your arm function will be measured between 12 and 32 weeks after the start of the study.",101,"You would have a DBS system implanted, undergo DBS program optimization, and participate in two five-month outpatient rehabilitation therapy programs.","Not stated in the trial record.",[23,26],"v2"]