[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03401762":3,"trial-entities:NCT03401762":121,"trial-summary:NCT03401762":124},{"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":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":50,"sex":62,"minimum_age":63,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":64,"std_ages":81,"locations":84,"central_contacts":93,"overall_officials":102,"references":103,"see_also_links":120},"NCT03401762","STU00203644","Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke","RECRUITING","2027-04","2026-04","2026-04-08","2018-01-15","Northwestern University","OTHER",false,"The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke.\n\nImpaired arm movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. These abnormal co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to reduce abnormal co-activation by providing feedback about individual muscle activations.\n\nThis randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors.",null,[18,19],"Stroke","Stroke, Acute",[21],"rehabilitation","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},96,"ESTIMATED",[30,39],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","MCI","EMG-controlled game",[35,36,37,38],"Acute stroke MCI","Chronic stroke MCI EMG triplets","Chronic stroke MCI Electromyogram (EMG) pairs","Chronic stroke MCI while reaching",{"type":31,"name":40,"description":41,"armGroupLabels":42},"Sham MCI","Sham control game",[43,44],"Acute stroke Sham MCI","Chronic stroke Sham MCI",[46],{"measure":47,"description":48,"timeFrame":49},"Wolf Motor Function Test","Timed","baseline to 6 weeks",[51,53,55,58,61],{"measure":52,"timeFrame":49},"Fugl-Meyer Assessment - Upper Extremity (UE)",{"measure":54,"timeFrame":49},"Motor Activity Log",{"measure":56,"description":57,"timeFrame":49},"Modified Ashworth Scale","Total score",{"measure":59,"timeFrame":60},"Fugl-Meyer Assessment UE","baseline to 10 weeks",{"measure":47,"description":48,"timeFrame":60},"ALL","21 Years",{"inclusion":65,"exclusion":71,"raw_text":80},[66,67,68,69,70],"Hemiparesis from first ever stroke at least 6 months prior to screening","Severe motor impairment (FMA of 7-30)","At least some voluntary shoulder and elbow muscle activation.","Hemiparesis from first ever stroke within the past 21 days","Severe motor impairment (FMA of 3-20), or total Manual Motor Score of 1-8 combined in Shoulder Abduction and Finger Extensors",[72,73,74,75,76,77,78,79],"Cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the MCI task","Visual impairment (such as hemianopia) preventing full view of the screen","Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest).","Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study","Inability to understand or follow commands in English due to aphasia or other reason","Diffuse or multifocal infarcts","Substantial arm pain preventing participation for 90 minutes a day","New spasticity treatment (pharmacological or Botox)","Inclusion Criteria:\n\nChronic stroke participants\n\n* Hemiparesis from first ever stroke at least 6 months prior to screening\n* Severe motor impairment (FMA of 7-30)\n* At least some voluntary shoulder and elbow muscle activation.\n\nAcute stroke participants\n\n* Hemiparesis from first ever stroke within the past 21 days\n* Severe motor impairment (FMA of 3-20), or total Manual Motor Score of 1-8 combined in Shoulder Abduction and Finger Extensors\n\nExclusion Criteria:\n\n* Cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the MCI task\n* Visual impairment (such as hemianopia) preventing full view of the screen\n* Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest).\n* Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study\n* Inability to understand or follow commands in English due to aphasia or other reason\n* Diffuse or multifocal infarcts\n* Substantial arm pain preventing participation for 90 minutes a day\n* New spasticity treatment (pharmacological or Botox)",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":12,"status":7,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Chicago","Illinois","60611","United States",{"lat":91,"lon":92},41.85003,-87.65005,[94,99],{"name":95,"role":96,"phone":97,"email":98},"Marc W Slutzky, MD, PhD","CONTACT","3125034653","mslutzky@northwestern.edu",{"name":100,"role":96,"email":101},"Cynthia Gorski","cynthia.gorski@northwestern.edu",[],[104,108,111,114,117],{"pmid":105,"type":106,"citation":107},"42261097","DERIVED","Khorasani A, Gorski CM, Hung NT, Hulsizer J, Paul V, Tomic G, Prakash PR, Park S, Seo G, Houskamp EJ, Lanis J, Hunzeker M, King E, Chappel A, Jampol A, Patel P, Gallagher C, Galant R, Rucker G, Lee J, Harvey RL, Roh J, Slutzky MW. Wearable Myoelectric Interface for Neurorehabilitation (MINT) to Recover Arm Activity After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2026 Jun 8:15459683261454937. doi: 10.1177\u002F15459683261454937. Online ahead of print.",{"pmid":109,"type":106,"citation":110},"40666333","Khorasani A, Gorski CM, Hung NT, Hulsizer J, Paul V, Tomic G, Prakash PR, Park S, Seo G, Houskamp EJ, Lanis J, Hunzeker M, King E, Chappel A, Jampol A, Patel P, Gallagher C, Galant R, Rucker G, Lee J, Harvey R, Roh J, Slutzky MW. Wearable Myoelectric Interface for Neurorehabilitation (MINT) to Recover Arm Function: a Randomized Controlled Trial. medRxiv [Preprint]. 2025 Jun 25:2025.06.24.25330240. doi: 10.1101\u002F2025.06.24.25330240.",{"pmid":112,"type":106,"citation":113},"38245730","Khorasani A, Hulsizer J, Paul V, Gorski C, Dhaher YY, Slutzky MW. Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study. J Neuroeng Rehabil. 2024 Jan 20;21(1):11. doi: 10.1186\u002Fs12984-024-01305-0.",{"pmid":115,"type":106,"citation":116},"37886579","Khorasani A, Hulsizer J, Paul V, Gorski C, Dhaher YY, Slutzky MW. Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study. Res Sq [Preprint]. 2023 Oct 9:rs.3.rs-3398815. doi: 10.21203\u002Frs.3.rs-3398815\u002Fv1.",{"pmid":118,"type":106,"citation":119},"34415114","Hung NT, Paul V, Prakash P, Kovach T, Tacy G, Tomic G, Park S, Jacobson T, Jampol A, Patel P, Chappel A, King E, Slutzky MW. Wearable myoelectric interface enables high-dose, home-based training in severely impaired chronic stroke survivors. Ann Clin Transl Neurol. 2021 Sep;8(9):1895-1905. doi: 10.1002\u002Facn3.51442. Epub 2021 Aug 20.",[],{"nct_id":4,"conditions":122,"biomarkers":123},[18],[],{"nct_id":4,"found":125,"summary":126,"prompt_version":136},true,{"design":127,"status":128,"heading":129,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This is a randomized, controlled, and blinded study, meaning participants are randomly assigned to receive either the MCI or a sham (inactive) version, and neither you nor the researchers will know which you are receiving. It plans to enroll 96 participants.","completed","Wearable MCI for Arm Movement After Stroke","This study is testing a wearable device called a myoelectric-computer interface (MCI) to help improve arm movement in people who have had a stroke. The MCI aims to reduce abnormal muscle co-activation (when muscles work against each other) by giving feedback about individual muscle activity. You might be able to join if you've had a stroke that caused arm weakness, either recently (within 21 days) or at least 6 months ago, and have severe motor impairment. The main goal is to see how well the MCI improves arm function, measured by the Wolf Motor Function Test, over 6 weeks. The study is currently recruiting 96 participants.","Your arm function will be measured at the beginning of the study and again at 6 weeks.",106,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]