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    "path": "/trials/NCT05756894",
    "result": {"pageContext":{"pagePath":"/trials/NCT05756894","trial":{"nct_id":"NCT05756894","brief_title":"Neurostimulation for Respiratory Function After Spinal Cord Injury","official_title":"Pilot Study: Spike-timing-dependent Plasticity for Respiratory Function After Spinal Cord Injury","about_trial":"This trial is enrolling individuals with chronic cervical spinal cord injuries to test the effect of non-invasive spinal cord electrical stimulation and respiratory exercise training. The stimulation will be applied to the spinal cord and to peripheral nerves (nerves in the body outside the brain and spinal cord) so that the signals are received at specific intervals. This so-called spike-timing-dependent plasticity (STDP) may promote recovery breathing and cardiopulmonary fitness. If included, participants will undergo 40 sessions of stimulation over the scalp and neck, followed by about 60 minutes of respiratory training. Assessment sessions will be completed before the intervention, after 20 sessions and after 40 sessions, 14 weeks total participation.","age_from":18,"age_to":85,"ais_a":false,"ais_b":false,"ais_c":false,"ais_d":false,"ais_e":false,"time_since_injury_from":6,"time_since_injury_from_unit":"months","time_since_injury_to":null,"time_since_injury_to_unit":null,"healthy_volunteers":false,"inclusion_criteria":["have respiratory deficits requiring ventilator use or demonstrate reduced vital capacity (less than 80%)","Have a caregiver or family member who is trained and willing to operate the ventilator during study visits","NOT be completely dependent on the support of a diaphragmatic pacer (24 hours per day)","NOT have history of head injury or stroke","NOT have history of seizures or epilepsy","NOT be taking medications that lower seizure threshold","NOT have metal in the skull including plates, shrapnel, cochlear implants or aneurysm clips"],"study_type":"interventional","allocation":"N/A","brief_description":"The purpose of this research study is to learn more about the connections between the brain, nerves, and diaphragm after experiencing a cervical spinal cord injury (SCI).The main question it aims to answer is:\n\nChanges in respiratory function and recovery using stimulation and respiratory exercise training in spinal cord-injured individuals.\n\nParticipants will complete a maximum of 55 study visits. They will be asked to complete about 40 treatment sessions which include multiple stimulation sessions over the scalp and neck, followed by about 60 minutes of respiratory training. Assessment sessions will be completed prior at baseline, after 20 sessions and after 40 sessions of study treatment.","detailed_description":"- participants will undergo 40 sessions of stimulation over the scalp and neck, followed by about 60 minutes of respiratory training.\n- Assessment sessions will be completed before the intervention, after 20 sessions and after 40 sessions.","final_testing_performed":"14 weeks","version_id":11,"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":5,"name":"General health","parent_id":null,"icon_name":"general-health"},"sex":"All","injury_level_from":"C1","injury_level_to":"C5","start_date":"2023-02-28","organization":"Shirley Ryan AbilityLab","benefits":[{"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":172,"name":"Motor Evoked Potentials (MEPs)","short_name":"MEPs","pivot":{"trial_id":5379,"outcome_measure_id":172}}],"recovery_mechanisms":[{"id":3,"name":"Neuroplasticity","pivot":{"trial_id":5379,"recovery_mechanism_id":3}}],"published_at":"2024-03-12T18:59:13.000000Z","modified_at":"2024-03-12T18:59:13.000000Z"},"layout":"trial"}},
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