[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07735234":3,"trial-entities:NCT07735234":94,"trial-summary:NCT07735234":98},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":63,"locations":66,"central_contacts":86,"overall_officials":89,"references":92,"see_also_links":93},"NCT07735234","HSC-MS-25-0434","Tolerability of Transcutaneous Vagal Nerve Stimulation","Tolerability of Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Stroke Survivors 1Tolerability of Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Stroke Survivors 1","NOT_YET_RECRUITING","2026-09-04","2026-07","2026-07-29","2026-07-30","The University of Texas Health Science Center, Houston","OTHER",false,"The purpose of this study is to assess the feasibility and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS) in childhood stroke survivors undergoing bi-manual occupational therapy.",null,[19],"Stroke",[21],"childhood stroke","INTERVENTIONAL","DEVICE_FEASIBILITY",[25],"NA",{"count":27,"type":28},1,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","transcutaneous auricular vagus nerve stimulation (taVNS)","The participant will undergo 2-hour therapy sessions, 3 times per week, for 4 weeks for a total of 12 occupational therapy sessions with stimulation after the visit. Participants will receive 90 minutes of therapy per session. Stimulation will be delivered using a biphasic rectangular pulse, pulse width of 250 us, frequency of 25Hz, duty cycle of 30 seconds on \u002F 30 seconds off during active therapy. 1 second ramp up and ramp down will be used to improve comfort. Maximum total stimulation per session will not exceed 45 minutes.",[32],[36,40],{"measure":37,"description":38,"timeFrame":39},"Tolerability as assessed by the ability of the participant to complete the treatment protocol","Tolerability will be assessed by whether the single enrolled participant completes all 12 taVNS-paired occupational therapy sessions and the 1-week post-therapy assessment without withdrawal or a protocol deviation due to tolerability concerns. Completion will be determined using study attendance records, withdrawal documentation, and protocol-deviation records","From baseline to end of treatment (5 weeks after baseline)",{"measure":41,"description":42,"timeFrame":43},"Change in arm function as assessed by the Fugl-Meyer score of Upper extremity","Upper extremity motor impairment will be assessed using the therapist-administered Upper Extremity Fugl-Meyer Assessment. The total score ranges from 0 to 66 points, with higher scores indicating better upper extremity motor function.","Baseline, 1-week post therapy",[45],{"measure":46,"timeFrame":47},"Change in tolerability as assessed by the number of side effects that occur as documented on the stimulation monitoring sheet","Pre and immediately post stimulation on day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11 and day 12","ALL","13 Years","21 Years",{"inclusion":52,"exclusion":59,"raw_text":62},[53,54,55,56,57,58],"Childhood stroke survivor - either arterial ischemic stroke or intracerebral hemorrhage.","Stroke must be childhood onset, defined as occurring day 29 of life to 18 years of age (per the American Heart Association's definition of childhood stroke)","6 months or greater from stroke onset","Arm impairment, defined as pediatric stroke outcome measure of 1 or greater of affected arm.","Affected arm Fugl-Meyer score of 60 or lower.","Able to participate in occupational therapy sessions.",[60,61],"Craniectomy without replacement of bone flap. Patients who underwent craniectomy will need the bone flap reattached prior to participation.","Presence of cranial metal implants or implant device that could be affected by taVNS: cochlear implant, implanted brain stimulator, or programmable ventriculoperitoneal shunt.","Inclusion Criteria:\n\n* Childhood stroke survivor - either arterial ischemic stroke or intracerebral hemorrhage.\n* Stroke must be childhood onset, defined as occurring day 29 of life to 18 years of age (per the American Heart Association's definition of childhood stroke)\n* 6 months or greater from stroke onset\n* Arm impairment, defined as pediatric stroke outcome measure of 1 or greater of affected arm.\n* Affected arm Fugl-Meyer score of 60 or lower.\n* Able to participate in occupational therapy sessions.\n\nExclusion Criteria:\n\n* Craniectomy without replacement of bone flap. Patients who underwent craniectomy will need the bone flap reattached prior to participation.\n* Presence of cranial metal implants or implant device that could be affected by taVNS: cochlear implant, implanted brain stimulator, or programmable ventriculoperitoneal shunt.",[64,65],"CHILD","ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":83},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Stuart M Fraser, MD","CONTACT","(713) 500-7142","Stuart.M.Fraser@uth.tmc.edu",{"name":80,"role":76,"phone":81,"email":82},"Melika A Abrahams","(713) 500-6138","Melika.A.Abrahams@uth.tmc.edu",{"lat":84,"lon":85},29.76328,-95.36327,[87,88],{"name":75,"role":76,"phone":77,"email":78},{"name":80,"role":76,"phone":81,"email":82},[90],{"name":75,"affiliation":13,"role":91},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Childhood Stroke",[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an interventional study with a planned enrollment of one participant. The phase of the study is not specified.","completed","Tolerability of Transcutaneous Vagal Nerve Stimulation for Childhood Stroke","This study is testing a device called transcutaneous auricular vagus nerve stimulation (taVNS) in children and young adults who have had a stroke. The goal is to see if taVNS is well-tolerated and can be used safely alongside occupational therapy to help improve arm function. Participants will be between 13 and 21 years old and have experienced a stroke between 29 days and 18 years of age, with some arm weakness. The main things the researchers are looking at are how well participants can complete the treatment and any changes in their arm function. The current recruitment status is unclear, and only one participant is planned for this study.","Arm function will be assessed at baseline and again one week after the therapy ends.",109,"You would have 2-hour therapy sessions, 3 times per week, for 4 weeks, totaling 12 occupational therapy sessions with stimulation after each visit. Each session involves 90 minutes of therapy.","Not stated in the trial record.",[32],"v2"]