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    "path": "/trials/NCT06087445",
    "result": {"pageContext":{"pagePath":"/trials/NCT06087445","trial":{"nct_id":"NCT06087445","brief_title":"A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia","official_title":"A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia","about_trial":"This pilot trial is enrolling 12 individuals with chronic cervical spinal cord injury to test the safety and feasibility of a functional orthotic sleeve on on grasp function. This device, the NeuroLife Sleeve System, is a non-invasive, forearm sleeve with 160 electrodes; it both records muscle activity and electrically stimulates the muscles. Muscle activity is recorded using electromyography (EMG), a technique that records naturally occurring muscle activity through a surface electrode. The muscles are stimulated using functional electrical stimulation (FES), a technique that applies electrical signals through the skin to nerves to cause contraction of weakened or paralyzed muscles. If included, participants will undergo 3 training sessions a week using the sleeve for 12 weeks. Final testing of arm and hand function will be performed after 4 months.","age_from":22,"age_to":null,"ais_a":true,"ais_b":true,"ais_c":true,"ais_d":true,"ais_e":false,"time_since_injury_from":12,"time_since_injury_from_unit":"months","time_since_injury_to":null,"time_since_injury_to_unit":null,"healthy_volunteers":false,"inclusion_criteria":["NOT have a pacemaker","NOT have uncontrolled seizure disorder","NOT be ventilator dependent"],"study_type":"interventional","allocation":"N/A","brief_description":"The goal of this pilot clinical study is to investigate the NeuroLife EMG-FES Sleeve System, a closed-loop approach to functional electrical stimulation, in adults (n=12) with chronic (>12 months) tetraplegia due to spinal cord injury. Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm which has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. The main questions this study aims to answer are: 1) What is the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia, and 2) Can EMG be used as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation? Participants will complete an intensive, task-oriented rehabilitation protocol using the NeuroLife EMG-FES System (3x/week x 12 weeks) in an outpatient setting. We will assess functional outcomes using standardized clinical measures of hand and arm function at six timepoints.","detailed_description":"- Participants will undergo 3 training sessions a week using the NeuroLife Sleeve System for a total of 12 weeks.\n- The NeuroLife Sleeve System is a non-invasive, forearm-worn sleeve with 160 electrodes that record muscle activity and electrically stimulate the muscles. \n- Final testing of upper-limb function will be performed after 4 months.","final_testing_performed":"4 months","version_id":10,"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":1,"name":"Arm/hand function","parent_id":null,"icon_name":"hand-expand"},"sex":"All","injury_level_from":"C1","injury_level_to":"C8","start_date":"2023-10-31","organization":"Ohio State University","benefits":[{"id":1,"name":"Arm/hand function","parent_id":null,"icon_name":"hand-expand"},{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"}],"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":62,"name":"Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)","short_name":"GRASSP","pivot":{"trial_id":5440,"outcome_measure_id":62}},{"id":63,"name":"Grasp and Release Test (GRT)","short_name":"GRT","pivot":{"trial_id":5440,"outcome_measure_id":63}},{"id":133,"name":"Spinal Cord Independence Measure (SCIM)","short_name":"SCIM","pivot":{"trial_id":5440,"outcome_measure_id":133}},{"id":155,"name":"Toronto Rehabilitation Institute Hand Function Test","short_name":null,"pivot":{"trial_id":5440,"outcome_measure_id":155}}],"recovery_mechanisms":[{"id":3,"name":"Neuroplasticity","pivot":{"trial_id":5440,"recovery_mechanism_id":3}}],"published_at":"2024-03-19T15:26:37.000000Z","modified_at":"2024-03-19T15:26:37.000000Z"},"layout":"trial"}},
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