[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05301140":3,"trial-entities:NCT05301140":278,"trial-summary:NCT05301140":281},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":41,"sex":48,"minimum_age":49,"maximum_age":23,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":56,"locations":59,"central_contacts":247,"overall_officials":255,"references":256,"see_also_links":277},"NCT05301140","MT-St-REG or GRASP Registry","Vivistim Registry for Paired VNS Therapy (GRASP)","RECRUITING","2028-12-31","2026-05","2026-06-29","2023-03-15","MicroTransponder Inc.","INDUSTRY",false,"The purpose of the Vivistim Registry for Paired VNS Therapy (GRASP) is to gather real-world information on patients with arm and hand deficits post-stroke who are considering Vivistim System treatment. Before and after Vivistim System implant, patient data will be collected and reported throughout the therapy process. Physicians or sites will receive appropriate remuneration for the effort and cost involved in collecting and transmitting this data to MicroTransponder Inc.","The registry is a data repository of information on patients considering implant of the Vivistim System. The Vivistim System is an FDA approved (P210007) device used to help improve upper limb motor deficits after a stroke. Most patients entered into the registry will go on to be implanted with the System although those who decide not to move forward with the implant procedure can still have data collected as a non-implant comparison group (as long as either or both FM-A \u002F WMFT assessments were collected). The primary purpose of the registry is to provide real-world usage and outcomes data on the Vivistim System. The patient outcome registry will collect acute and long-term follow-up data on Vivistim implanted patients treated with Paired Vagus Nerve Stimulation (Paired VNS™) post-FDA approval.\n\nHistorical and implant information as well as quality of life information will be gathered on patients who consider implant of the Vivistim® System. Data will be collected at baseline, 3, 6, and 12 months after implantation, as well as yearly thereafter for up to three (3) years post-implant. Patients who decide not to have the Vivistim System implanted can continue to have data collected for comparison purposes.\n\nContributing sites and physicians will have access to their own site data and can have anonymized summary analyses on all aggregated data; sites will not have access to other sites' individual level data. Physicians can then use the above information to facilitate patient selection and treatment. Publication (oral or written) of data in the registry, other than individual site data, will not be permitted without the express written advance approval of MicroTransponder, Inc. and the other physicians contributing to the dataset.",[18],"Upper Extremity Problem",[20,21],"Ischemic Stroke","Paired Vagus Nerve Stimulation","OBSERVATIONAL",null,[],{"count":26,"type":27},1000,"ESTIMATED",[29],{"type":30,"name":31,"description":32},"DEVICE","Vivistim System","VNS Paired with rehabilitation movements",[34,38],{"measure":35,"description":36,"timeFrame":37},"Fugl Meyer Assessment (FM-A)","Change in Fugl Meyer Assessment score","6 months",{"measure":39,"description":40,"timeFrame":37},"Wolf Motor Function Test (WMFT)","Change in Wolf Motor Function Test score",[42,45],{"measure":43,"description":44,"timeFrame":37},"Stroke Impact Scale (SIS)","Change in Stroke Impact Scale",{"measure":46,"description":47,"timeFrame":37},"Motor Activity Log (MAL)","Change in Motor Activity Log","ALL","22 Years",{"inclusion":51,"exclusion":53,"raw_text":55},[52],"Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke",[54],"Not eligible for surgery","Inclusion Criteria:\n\n* Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke\n\nExclusion Criteria:\n\n* Not eligible for surgery",[57,58],"ADULT","OLDER_ADULT",[60,75,88,100,113,126,139,152,162,177,190,202,214,226,238],{"facility":61,"status":7,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":72},"Advent Health Orlando","Orlando","Florida","32803","United States",[67],{"name":68,"role":69,"phone":70,"email":71},"Ariana Mora","CONTACT","407-609-9057","Ariana.Mora@adventhealth.com",{"lat":73,"lon":74},28.53834,-81.37924,{"facility":76,"status":7,"city":77,"state":78,"zip":79,"country":65,"contacts":80,"geoPoint":85},"Alexian Brothers Health System","Elk Grove Village","Illinois","60007",[81],{"name":82,"role":69,"phone":83,"email":84},"Ashley Madsen","847.437.5500 x7273","ashley.madsen@ascension.org",{"lat":86,"lon":87},42.00392,-87.97035,{"facility":89,"status":7,"city":90,"state":78,"zip":91,"country":65,"contacts":92,"geoPoint":97},"Endeavor Health","Evanston","60201",[93],{"name":94,"role":69,"phone":95,"email":96},"Nancy Sola","847-570-2025","nancy.sola@endeavorhealth.org",{"lat":98,"lon":99},42.04114,-87.69006,{"facility":101,"status":7,"city":102,"state":103,"zip":104,"country":65,"contacts":105,"geoPoint":110},"University of Kansas Medical Center","Kansas City","Kansas","66160",[106],{"name":107,"role":69,"phone":108,"email":109},"Sasha Moores","913-945-6630","smoores@kumc.edu",{"lat":111,"lon":112},39.11417,-94.62746,{"facility":114,"status":7,"city":115,"state":116,"zip":117,"country":65,"contacts":118,"geoPoint":123},"University of Kentucky Research Foundation","Lexington","Kentucky","40506",[119],{"name":120,"role":69,"phone":121,"email":122},"Rachel Norris","859-218-1644","rachel.norris@uky.edu",{"lat":124,"lon":125},37.98869,-84.47772,{"facility":127,"status":7,"city":128,"state":129,"zip":130,"country":65,"contacts":131,"geoPoint":136},"Overlook Medical Center-Atlantic Health","Morristown","New Jersey","07960",[132],{"name":133,"role":69,"phone":134,"email":135},"Ronald Benitez","973-993-7100","ronald.benitez@atlanticbrainandspine.org",{"lat":137,"lon":138},40.79677,-74.48154,{"facility":140,"status":7,"city":141,"state":142,"zip":143,"country":65,"contacts":144,"geoPoint":149},"Albany Medical College","Albany","New York","12208",[145],{"name":146,"role":69,"phone":147,"email":148},"Alexandra Paul","518-262-5088","paula1@amc.edu",{"lat":150,"lon":151},42.65258,-73.75623,{"facility":153,"status":7,"city":142,"state":142,"zip":154,"country":65,"contacts":155,"geoPoint":159},"Mt. Sinai","10029",[156],{"name":157,"role":69,"email":158},"Clinical Research Coordinator","Karen.Gonzalez2@mountsinai.org",{"lat":160,"lon":161},40.71427,-74.00597,{"facility":163,"status":7,"city":164,"state":142,"zip":165,"country":65,"contacts":166,"geoPoint":174},"Burke Rehabilitation Hospital","White Plains","10605",[167,171],{"name":168,"role":69,"phone":169,"email":170},"Josette Hartnett","914-597-2367","johartnett@burke.org",{"name":172,"role":173},"Jaskiran Ghuman","PRINCIPAL_INVESTIGATOR",{"lat":175,"lon":176},41.03399,-73.76291,{"facility":178,"status":7,"city":179,"state":180,"zip":181,"country":65,"contacts":182,"geoPoint":187},"Jefferson Health - Lehigh Valley Health Network","Allentown","Pennsylvania","18103",[183],{"name":184,"role":69,"phone":185,"email":186},"Christina Gogal, Clinical Research Coordinator","610-402-1555","Christina.Gogal@jefferson.edu",{"lat":188,"lon":189},40.60843,-75.49018,{"facility":191,"status":7,"city":192,"state":180,"zip":193,"country":65,"contacts":194,"geoPoint":199},"Thomas Jefferson","Philadelphia","19107",[195],{"name":196,"role":69,"phone":197,"email":198},"Nicole Gerhardt","215-503-0351","Nicole.Gerhardt@jefferson.edu",{"lat":200,"lon":201},39.95238,-75.16362,{"facility":203,"status":7,"city":204,"state":180,"zip":205,"country":65,"contacts":206,"geoPoint":211},"Allegheny General Hospital","Pittsburgh","15212",[207],{"name":208,"role":69,"phone":209,"email":210},"Alexander Whiting","412-523-8014","alexander.whiting@ahn.org",{"lat":212,"lon":213},40.44062,-79.99589,{"facility":215,"status":7,"city":216,"state":180,"zip":217,"country":65,"contacts":218,"geoPoint":223},"Allied Services Institute of Rehabilitation Medicine","Scranton","18501",[219],{"name":220,"role":69,"phone":221,"email":222},"Diana Pope Albright","570 348-1305","Dpope@allied-services.org",{"lat":224,"lon":225},41.40916,-75.6649,{"facility":227,"status":7,"city":228,"state":229,"zip":230,"country":65,"contacts":231,"geoPoint":235},"St David's Medical Center","Austin","Texas","78701",[232],{"name":233,"role":69,"email":234},"Robert Lee","Robert.Lee3@stdavids.com",{"lat":236,"lon":237},30.26715,-97.74306,{"facility":239,"status":7,"city":228,"state":229,"zip":240,"country":65,"contacts":241,"geoPoint":246},"Physical Medicine and Neurotoxin Institute","78759",[242],{"name":243,"role":69,"phone":244,"email":245},"Joe Uriquidez","(512) 249-5583","MD@PMNInstitute.com",{"lat":236,"lon":237},[248,252],{"name":249,"role":69,"phone":250,"email":251},"Brent Tarver, BSEE","8556289375","brent.tarver@mobia.com",{"name":253,"role":69,"phone":250,"email":254},"Diana Hansen","diana.hansen@mobia.com",[],[257,261,264,267,270,273],{"pmid":258,"type":259,"citation":260},"33894832","BACKGROUND","Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016\u002FS0140-6736(21)00475-X.",{"pmid":262,"type":259,"citation":263},"30355189","Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161\u002FSTROKEAHA.118.022279.",{"pmid":265,"type":259,"citation":266},"30983963","Engineer ND, Kimberley TJ, Prudente CN, Dawson J, Tarver WB, Hays SA. Targeted Vagus Nerve Stimulation for Rehabilitation After Stroke. Front Neurosci. 2019 Mar 29;13:280. doi: 10.3389\u002Ffnins.2019.00280. eCollection 2019.",{"pmid":268,"type":259,"citation":269},"32476617","Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177\u002F1545968320924361. Epub 2020 Jun 1.",{"pmid":271,"type":259,"citation":272},"26645257","Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161\u002FSTROKEAHA.115.010477. Epub 2015 Dec 8.",{"pmid":274,"type":275,"citation":276},"41988415","DERIVED","Doherty SJ, Prudente CN, Adham Hinds R, Pierce D, Engineer ND, Carrithers J, Hansen D, Tarver WB. Study protocol for the Vivistim GRASP registry: capturing real-world outcomes of paired vagus nerve stimulation in the chronic stroke population. Front Stroke. 2026 Mar 31;5:1751659. doi: 10.3389\u002Ffstro.2026.1751659. eCollection 2026.",[],{"nct_id":4,"conditions":279,"biomarkers":280},[20,18],[],{"nct_id":4,"found":282,"summary":283,"prompt_version":293},true,{"design":284,"status":285,"heading":286,"summary":287,"follow_up":288,"word_count":289,"commitments":290,"compensation":291,"drugs_mentioned":292},"This is an observational study, meaning researchers will collect information without assigning specific treatments. It plans to enroll 1000 participants.","completed","Vivistim Registry for Upper Arm Recovery After Stroke","This study, called the Vivistim Registry for Paired VNS Therapy (GRASP), is collecting information on people who have arm and hand weakness after a stroke and are considering treatment with the Vivistim System. The Vivistim System is a device that uses Vagus Nerve Stimulation (VNS) paired with rehabilitation exercises to help improve arm movement. Researchers want to see how well the Vivistim System works in real-world settings. You would be eligible if you are 22 years or older, have arm weakness from an ischemic stroke, and are considering the Vivistim System. The study will measure your arm function using tests like the Fugl Meyer Assessment (FM-A) and Wolf Motor Function Test (WMFT) at 6 months to see if your arm movement improves. The current status of this study is unclear.","You will be followed for up to three years after implantation, with primary outcomes measured at 6 months.",130,"Data will be collected at the start, then at 3, 6, and 12 months after implantation, and yearly for up to three years. If you don't get the implant, data can still be collected for comparison.","Physicians or sites will receive payment for collecting and sending data. It is not stated whether participants are paid or reimbursed.",[31],"v2"]