[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06541015":3,"trial-entities:NCT06541015":107,"trial-summary:NCT06541015":113},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":76,"locations":79,"central_contacts":99,"overall_officials":102,"references":105,"see_also_links":106},"NCT06541015","STU-2018-0431","Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients","TENS (Transcutaneous Electrical Nerve Stimulation): Effect of Transcutaneous Spinal Direct Current Stimulation on Lower Limb Reflex, Volitional, and Functional Movement Post-stroke","RECRUITING","2026-12-31","2026-02","2026-03-30","2019-06-21","University of Texas Southwestern Medical Center","OTHER",false,"The subjects will be asked to attend minimum 15 separate sessions, 6 for testing changes in reflex behaviors, 3 for testing changes in the influence of descending motor tracts on spinal motor neurons, 3 for each testing functional movement in response to a trip event and cross-tilt walking adaptation pattern, as part of their participation in the research study. The estimated amount of time to enroll and collect the data for each of the subjects is four months' time. The data will be analyzed and ready for grant preparation (if successful) in approximately four months after the start of the study.","The subjects will be asked to attend minimum 15 separate sessions, 6 for testing changes in reflex behaviors, 3 for testing changes in the influence of descending motor tracts on spinal motor neurons, 3 for each testing functional movement in response to a trip event and cross-tilt walking adaptation pattern, as part of their participation in the research study. During the first session, the subjects will be screened and informed about the research study, so they can consent to their participation. They will also be oriented to the lab, the equipment, as well as the research team. Following the orientation, the remaining time will consist of approximately 3 hours of data collection. The remaining will last approximately 3 hours and consist of the completion of data collection. Additional sessions after 15 sessions will be optional and will be reserved for completing data collection if the subject is unable to complete a trial session or to analyze for test retest variability within the subject population. The estimated amount of time to enroll and collect the data for each of the subjects is four months' time. The data will be analyzed and ready for grant preparation (if successful) in approximately four months after the start of the study.",[19,20],"Hemiplegia and\u002For Hemiparesis Following Stroke","Anterior Circulation Stroke of Uncertain Pathology",[22],"Single unilateral stroke with single lower limb hemiparesis","INTERVENTIONAL","BASIC_SCIENCE",[26],"NA",{"count":28,"type":29},100,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","InTENSity 10 TENS Stimulator","InTENSity 10 TENS stimulator is a portable electrotherapy device featuring Transcutaneous Electrical Nerve Stimulation (TENS) therapeutic device. The stimulator sends a gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of device are controlled by the buttons.",[36],"Post Stroke - individuals with history of single unilateral stroke (>6 months since onset)",[38,42,45],{"measure":39,"description":40,"timeFrame":41},"Reflex Testing","Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on reflexes in post-stroke individuals","3 months",{"measure":43,"description":44,"timeFrame":41},"Walking Testing","Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on walking in post-stroke individuals",{"measure":46,"description":47,"timeFrame":41},"Adaptation Testing","Test if tsDCS (transcutaneous spinal direct current stimulation) has any beneficial effect on adaptation pattern in post-stroke individuals",[],"ALL","18 Years","80 Years",true,{"inclusion":54,"exclusion":60,"raw_text":75},[55,56,57,58,59,56,57],"History of single unilateral stroke with subsequent lower limb hemiparesis on either side (\\> 6 months since onset)","Ability to walk as part of activities of daily living","Age between 18 and 80","No history of stroke, cerebral palsy, injury or surgery to the lower limb.","Currently not taking any central nervous system (CNS) affecting medication.",[61,62,63,64,65,66,67,68,69,70,71,72,61,73,74,64,65,66,67,68,69,70,71,72,63],"Presence of concurrent severe medical illness including unhealed pressure sore, active or untreated infection, thromboembolic disease, severe contracture, osteoporosis, heterotropic classification, lower limb fracture, severe pulmonary disease or cardiovascular instability, uncontrolled seizure, uncontrolled diabetes","History of any neurological injury other than a single stroke","Has received a Botox injection in the lower extremity within the last 4 months","Any cognitive deficit that would prevent informed consent or ability to perform the experiment","History of prior injury or surgery to the hip or knee","Presence of significant lower extremity edema - Presence of cardiac pacemaker or any other electrically implanted device - Use of braces limiting harness\u002FLokomat fit (Any spinal orthoses such as TLSO, HALO)","Weight greater than 300 pounds","Adults unable to consent, infants, children, teenagers, pregnant women and prisoners will not be included in the study","Clinically significant depression, psychiatric disorders, or ongoing drug abuse","Actively taking medications with agents known to increase (e.g. amphetamines) or decrease motor system excitability","Suffered a concussion in the last 6 months.","Unexplained headaches","History of any neurological injury","Taking any medication affecting change in CNS","Post Stroke Cohort:\n\nInclusion Criteria:\n\n* History of single unilateral stroke with subsequent lower limb hemiparesis on either side (\\> 6 months since onset)\n* Ability to walk as part of activities of daily living\n* Age between 18 and 80\n\nExclusion Criteria:\n\n* Presence of concurrent severe medical illness including unhealed pressure sore, active or untreated infection, thromboembolic disease, severe contracture, osteoporosis, heterotropic classification, lower limb fracture, severe pulmonary disease or cardiovascular instability, uncontrolled seizure, uncontrolled diabetes\n* History of any neurological injury other than a single stroke\n* Has received a Botox injection in the lower extremity within the last 4 months\n* Any cognitive deficit that would prevent informed consent or ability to perform the experiment\n* History of prior injury or surgery to the hip or knee\n* Presence of significant lower extremity edema - Presence of cardiac pacemaker or any other electrically implanted device - Use of braces limiting harness\u002FLokomat fit (Any spinal orthoses such as TLSO, HALO)\n* Weight greater than 300 pounds\n* Adults unable to consent, infants, children, teenagers, pregnant women and prisoners will not be included in the study\n* Clinically significant depression, psychiatric disorders, or ongoing drug abuse\n* Actively taking medications with agents known to increase (e.g. amphetamines) or decrease motor system excitability\n* Suffered a concussion in the last 6 months.\n* Unexplained headaches\n\nHealthy Cohort:\n\nInclusion Criteria:\n\n* No history of stroke, cerebral palsy, injury or surgery to the lower limb.\n* Currently not taking any central nervous system (CNS) affecting medication.\n* Ability to walk as part of activities of daily living\n* Age between 18 and 80\n\nExclusion Criteria:\n\n* Presence of concurrent severe medical illness including unhealed pressure sore, active or untreated infection, thromboembolic disease, severe contracture, osteoporosis, heterotropic classification, lower limb fracture, severe pulmonary disease or cardiovascular instability, uncontrolled seizure, uncontrolled diabetes\n* History of any neurological injury\n* Taking any medication affecting change in CNS\n* Any cognitive deficit that would prevent informed consent or ability to perform the experiment\n* History of prior injury or surgery to the hip or knee\n* Presence of significant lower extremity edema - Presence of cardiac pacemaker or any other electrically implanted device - Use of braces limiting harness\u002FLokomat fit (Any spinal orthoses such as TLSO, HALO)\n* Weight greater than 300 pounds\n* Adults unable to consent, infants, children, teenagers, pregnant women and prisoners will not be included in the study\n* Clinically significant depression, psychiatric disorders, or ongoing drug abuse\n* Actively taking medications with agents known to increase (e.g. amphetamines) or decrease motor system excitability\n* Suffered a concussion in the last 6 months.\n* Unexplained headaches\n* Has received a Botox injection in the lower extremity within the last 4 months",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":96},"University of Texas Medical Center","Dallas","Texas","75390","United States",[87,92],{"name":88,"role":89,"phone":90,"email":91},"Yasin Dhaher, Ph.D.","CONTACT","214-645-0064","yasin.dhaher@utsoutwestern.edu",{"name":93,"role":89,"phone":94,"email":95},"Yu-Chen Chung, Ph.D.","214-648-8838","yu-chen.chung@utsouthwestern.edu",{"lat":97,"lon":98},32.78306,-96.80667,[100,101],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":95},[103],{"name":88,"affiliation":13,"role":104},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":108,"biomarkers":112},[109,110,111],"Hemiparesis","Hemiplegia","Stroke",[],{"nct_id":4,"found":52,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 100 participants.","completed","Study of TENS for Post-Stroke Recovery","This study is looking at how Transcutaneous Electrical Nerve Stimulation (TENS) using the InTENSity 10 TENS Stimulator might help people who have had a stroke. TENS is a portable device that sends gentle electrical currents to nerves and muscles through pads placed on the skin. We want to see if this treatment can improve reflexes, walking ability, and how well people adapt to different movements after a stroke. You might be able to join if you are between 18 and 80 years old, had a single stroke at least 6 months ago that caused weakness on one side of your body (hemiparesis), and can walk as part of your daily activities. The study is currently unclear about its recruitment status and plans to enroll 100 participants.","The primary outcomes, such as reflex and walking tests, will be measured at 3 months after the intervention.",126,"You would attend a minimum of 15 separate sessions. The first session involves screening, consent, orientation, and about 3 hours of data collection. Subsequent sessions will also last approximately 3 hours.","Not stated in the trial record.",[33],"v2"]