[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04750564":3,"trial-entities:NCT04750564":97,"trial-summary:NCT04750564":102},{"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":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":64,"locations":67,"central_contacts":87,"overall_officials":91,"references":95,"see_also_links":96},"NCT04750564","HSC-MS-20-1286 (Experiment 2)","BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot)","BreEStim for Post-Stroke Motor Recovery","RECRUITING","2027-12-31","2026-05","2026-06-03","2025-09-01","The University of Texas Health Science Center, Houston","OTHER",false,"The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with severe impairment.",null,[19],"Motor Recovery",[21,19,22],"Finger flexor spasticity","BreEStim","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},4,"ESTIMATED",[31,35],{"type":32,"name":22,"description":33,"armGroupLabels":34},"DEVICE","BreEStim will applied for 10 to 20 minutes.",[22],{"type":32,"name":36,"description":37,"armGroupLabels":38},"EStim","EStim will applied for 10 to 20 minutes.",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)","MAS will be performed to check changes of finger flexor spasticity after one session of treatment.\n\nThe Modified Ashworth scale (MAS) scoring is categorical and ranges from 0 to 4, as follows:\n\n0: No increase in muscle tone\n\n1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM)\n2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved\n3. Considerable increase in muscle tone, passive movement difficult\n4. Affected part(s) rigid in flexion or extension","Baseline, 5 minutes after intervention",[45],{"measure":46,"description":47,"timeFrame":43},"Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale","FMA will be assessed to test function changes of finger extensors and hand function after one session of treatment.\n\nThe upper limb motor function domain of the FMA scale will be used, and the score range for this domain is 0 to 66, with a higher score indicating better function.","ALL","18 Years","75 Years",{"inclusion":52,"exclusion":56,"raw_text":63},[53,54,55],"has post stroke ≥ 6 months , medically stable;","Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);","MAS score ≥ 1, i.e., detectable finger flexor hypertonia;",[57,58,59,60,61,62],"Patients with visual deficit\u002Fneglect; hearing or cognitive impairment;","Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);","Patients that are currently adjusting tone alternating medications (e.g., baclofen), or","Patients received botulinum toxin injection to the arm\u002Ffingers \\\u003C4 months, or phenol injections \\\u003C 2 years;","Patients with a pacemaker;","Women who are pregnant.","Inclusion criteria:\n\n* has post stroke ≥ 6 months , medically stable;\n* Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);\n* MAS score ≥ 1, i.e., detectable finger flexor hypertonia;\n\nExclusion criteria include:\n\n* Patients with visual deficit\u002Fneglect; hearing or cognitive impairment;\n* Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);\n* Patients that are currently adjusting tone alternating medications (e.g., baclofen), or\n* Patients received botulinum toxin injection to the arm\u002Ffingers \\\u003C4 months, or phenol injections \\\u003C 2 years;\n* Patients with a pacemaker;\n* Women who are pregnant.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":84},"The University of Texas Health Science Center","Houston","Texas","77030","United States",[75,80],{"name":76,"role":77,"phone":78,"email":79},"Sheng Li, MD, PhD","CONTACT","(713) 500-5874","sheng.li@uth.tmc.edu",{"name":81,"role":77,"phone":82,"email":83},"Shengai Li, MS","713-797-7561","shengai.li@uth.tmc.edu",{"lat":85,"lon":86},29.76328,-95.36327,[88,90],{"name":76,"role":77,"phone":89,"email":79},"(713) 797-7125",{"name":81,"role":77,"phone":82,"email":83},[92],{"name":76,"affiliation":93,"role":94},"University of Texas","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":101},[99,100],"Spasticity","Stroke",[],{"nct_id":4,"found":103,"summary":104,"prompt_version":114},true,{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an interventional pilot study with a planned enrollment of 4 participants. It is comparing two device interventions: BreEStim and EStim.","completed","BreEStim for Motor Recovery in Chronic Stroke","This pilot study is exploring a new treatment called BreEStim (Breathing-controlled electrical stimulation) to help people who have had a stroke. It aims to see if BreEStim can reduce stiffness (spasticity) in finger muscles and improve hand function. The study is also comparing BreEStim to standard electrical stimulation (EStim). You might be able to join if you are 18 to 75 years old, had a stroke at least 6 months ago, and have some finger stiffness. People with certain vision, hearing, or thinking problems, or lung disease, cannot participate. The study is currently unclear about its recruitment status and plans to enroll 4 participants.","Your finger stiffness will be measured 5 minutes after the intervention.",104,"You would receive either BreEStim or EStim for 10 to 20 minutes. Your finger stiffness will be measured at the start and 5 minutes after the intervention.","Not stated in the trial record.",[22,36],"v2"]