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    "path": "/trials/NCT04604951",
    "result": {"pageContext":{"pagePath":"/trials/NCT04604951","trial":{"nct_id":"NCT04604951","brief_title":"Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury","official_title":"Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury","about_trial":"This trial is recruiting individuals with chronic spinal cord injuries to test the effect of skin surface electrical stimulation (transcutaneous spinal cord stimulation: TSCS) on bladder, bowel, and sexual function, as well as on blood pressure (i.e. autonomic function). Earlier studies showed that spinal cord stimulation with an implanted stimulator promoted recovery in these functions; this trial involves no surgery. Participants will be evaluated over 6 weeks, and then will receive one of two  interventions for another 6 weeks: 1) moderate TSCS (2 days/week for 12 intervention sessions); or 2) intensive (5 days/week for 30 intervention sessions). In the 12 weeks after the intervention, there will be another 4 follow-up visits, for a total participation time of 25 weeks.","age_from":18,"age_to":65,"ais_a":true,"ais_b":true,"ais_c":false,"ais_d":false,"ais_e":false,"time_since_injury_from":1,"time_since_injury_from_unit":"years","time_since_injury_to":100,"time_since_injury_to_unit":"years","healthy_volunteers":false,"inclusion_criteria":["be a resident of British Columbia, Canada with active provincial medical services plan.","have a history of bladder dysfunction and, bowel or sexual dysfunction."],"study_type":"interventional","allocation":"Randomized","brief_description":"Recent findings have demonstrated that electrical stimulation to the spinal cord (i.e. implanted electrodes) can significantly recover bladder, bowel, and sexual function after injury. While promising, a major drawback is that individuals must undergo a highly invasive and expensive surgical procedure to implant the stimulator on top of the spinal cord. Moreover, the inability to re-position the implanted stimulator considerably limits the flexibility of this procedure.\n\nIn this project, the investigators propose a comprehensive clinical study examining the effects of TCSCS in promoting recovery of these crucial functions in individuals with spinal cord injury (SCI). This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.","detailed_description":"The participant will be screened and evaluated over 6 visits over 6 weeks, and then will receive the intervention over another 6 weeks.  The intervention will be either 1) moderate TCSCS (2 days/week for 12 intervention sessions) or 2) intense TCSCS (5 days/week for 30 intervention sessions).\nIn the 12 weeks after finishing the intervention, there will be another 4 follow-up visits.  Overall, the total duration of participation is 25 weeks.","final_testing_performed":null,"version_id":7,"emsci_trial":false,"curation_status":"curated","overall_recruitment_status":"recruiting","primary_intervention":{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},"primary_benefit":{"id":2,"name":"Bladder health/function","parent_id":null,"icon_name":"bladder"},"sex":"All","injury_level_from":"C1","injury_level_to":"T6","start_date":"2022-05-02","organization":"University of British Columbia","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":6,"name":"Mental health and psychosocial factors","parent_id":null,"icon_name":"mental-health"},{"id":9,"name":"Sexual health","parent_id":null,"icon_name":"love-heart"}],"injuries":[{"id":3,"name":"Traumatic","parent_id":1,"pivot":{"trial_id":2830,"injury_id":3}}],"interventions":[{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"}],"outcome_measures":[],"recovery_mechanisms":[],"published_at":"2021-11-05T20:04:23.000000Z","modified_at":"2021-11-05T20:04:23.000000Z"},"layout":"trial"}},
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