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    "result": {"pageContext":{"pagePath":"/trials/NCT07445685","trial":{"nct_id":"NCT07445685","brief_title":"Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury.","official_title":"Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury: a Randomized, Double-blind Study.","about_trial":"The goal of this clinical trial is to learn if transcutaneous spinal cord stimulation works to improve lower limb motor function in adults with incomplete spinal cord injury. It will also learn about the safety of transcutaneous spinal cord stimulation when combined with assisted cycling training.\n\nThe main questions it aims to answer are:\n\nDoes transcutaneous spinal cord stimulation while training with assisted cycling improve lower limb motor function? Does transcutaneous spinal cord stimulation while training with assisted cycling reduce muscle spasms or improve bladder or bowel function?\n\nResearchers will compare transcutaneous spinal cord stimulation to a sham (a look-alike stimulation that does not deliver therapeutic electrical current) to see if transcutaneous spinal cord stimulation during assisted cycling improves motor function in people with incomplete spinal cord injury.\n\nParticipants will:\n\nParticipate in the training program with assisted cycling. Receive active stimulation or placebo stimulation during this training. Undergo motor function assessments, and be monitored about muscle spasms, bladder and bowel function and side effects.\n\nThe study will include 40 participants with incomplete spinal cord injury with less than 12 months since injury.","age_from":18,"age_to":null,"ais_a":false,"ais_b":true,"ais_c":true,"ais_d":true,"ais_e":false,"time_since_injury_from":null,"time_since_injury_from_unit":null,"time_since_injury_to":12,"time_since_injury_to_unit":"months","healthy_volunteers":false,"inclusion_criteria":null,"study_type":"interventional","allocation":"Randomized","brief_description":"The goal of this clinical trial is to learn if transcutaneous spinal cord stimulation works to improve lower limb motor function in adults with incomplete spinal cord injury. It will also learn about the safety of transcutaneous spinal cord stimulation when combined with assisted cycling training.\n\nThe main questions it aims to answer are:\n\nDoes transcutaneous spinal cord stimulation while training with assisted cycling improve lower limb motor function? Does transcutaneous spinal cord stimulation while training with assisted cycling reduce muscle spasms or improve bladder or bowel function?\n\nResearchers will compare transcutaneous spinal cord stimulation to a sham (a look-alike stimulation that does not deliver therapeutic electrical current) to see if transcutaneous spinal cord stimulation during assisted cycling improves motor function in people with incomplete spinal cord injury.\n\nParticipants will:\n\nParticipate in the training program with assisted cycling. Receive active stimulation or placebo stimulation during this training. Undergo motor function assessments, and be monitored about muscle spasms, bladder and bowel function and side effects.\n\nThe study will include 40 participants with incomplete spinal cord injury with less than 12 months since injury.","detailed_description":"Project Title: Transcutaneous Electrical Spinal Cord Stimulation During Assisted Cycling Training for Incomplete Spinal Cord Injury. A Randomized Double-Blind Study.\n\nSponsor: Hospital Sant Joan de Déu Palma-Inca\n\nPrincipal Investigator: Luis Garcés Pérez, MD. Attending Physician. Department of Rehabilitation. Hospital Sant Joan de Déu Palma-Inca\n\nStudy Site(s): Hospital Sant Joan de Déu Palma-Inca\n\nStudy Design: Randomized, double-blind, sham-controlled clinical trial\n\nCondition or Disease Under Study: Spinal cord injury\n\nPrimary and Secondary Objectives:\n\nThe primary objective is to evaluate the effectiveness of transcutaneous spinal cord stimulation in improving lower limb motor function when used in combination with assisted cycling training.\n\nSecondary objectives are to assess whether it has an effect on the frequency of muscle spasms and on bladder or bowel function.\n\nPrimary Outcome Measure: Lower Extremity Motor Score (LEMS) of the ASIA Impairment Scale for spinal cord injury.\n\nStudy Population and Total Number of Subjects: Individuals with incomplete spinal cord injury (ASIA B, C, or D) with less than 12 months since injury. A total of 40 subjects will be required for the study.","final_testing_performed":"4 weeks","version_id":2,"emsci_trial":false,"curation_status":"uncurated","overall_recruitment_status":"recruiting-soon","primary_intervention":{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},"primary_benefit":{"id":12,"name":"Standing/walking/mobility","parent_id":null,"icon_name":"walking"},"sex":"All","injury_level_from":"C2","injury_level_to":"T11","start_date":"2026-03-01","organization":"Fundació Sant Joan de Déu","benefits":[{"id":2,"name":"Bladder health/function","parent_id":null,"icon_name":"bladder"},{"id":4,"name":"Bowel health","parent_id":null,"icon_name":"bowel"},{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},{"id":11,"name":"Spasticity","parent_id":null,"icon_name":"wave"},{"id":12,"name":"Standing/walking/mobility","parent_id":null,"icon_name":"walking"}],"injuries":[],"interventions":[{"id":3,"name":"Rehabilitation","parent_id":null,"icon_name":"medical-rehabilitation"},{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"}],"outcome_measures":[{"id":1,"name":"10 Meter Walking Test (10 MWT)","short_name":"10 MWT","pivot":{"trial_id":7920,"outcome_measure_id":1}},{"id":9,"name":"Ashworth and Modified Ashworth Scale (MAS)","short_name":"MAS","pivot":{"trial_id":7920,"outcome_measure_id":9}},{"id":193,"name":"International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)","short_name":"ISNCSCI","pivot":{"trial_id":7920,"outcome_measure_id":193}},{"id":91,"name":"Neurogenic Bowel Dysfunction Score (NBD or NBDS)","short_name":"NBD or NBDS","pivot":{"trial_id":7920,"outcome_measure_id":91}},{"id":99,"name":"Penn Spasm Frequency Scale (PSFS)","short_name":"PSFS","pivot":{"trial_id":7920,"outcome_measure_id":99}},{"id":110,"name":"Qualiveen","short_name":null,"pivot":{"trial_id":7920,"outcome_measure_id":110}},{"id":153,"name":"Timed Up and Go Test (TUG)","short_name":"TUG","pivot":{"trial_id":7920,"outcome_measure_id":153}},{"id":158,"name":"Walking Index for Spinal Cord Injury (WISCI) and WISCI II","short_name":"WISCI","pivot":{"trial_id":7920,"outcome_measure_id":158}}],"recovery_mechanisms":[],"published_at":"2026-03-30T09:41:01.000000Z","modified_at":"2026-03-30T09:41:01.000000Z"},"layout":"trial"}},
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