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    "path": "/trials/NCT06493071",
    "result": {"pageContext":{"pagePath":"/trials/NCT06493071","trial":{"nct_id":"NCT06493071","brief_title":"Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Inflammation and Depression Following SCI","official_title":"Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) as an Anti-inflammatory Strategy for the Treatment of Depression Following Spinal Cord Injury","about_trial":"This trial is enrolling 44 participants with spinal cord injury to test the effect of  stimulating a nerve  (vagus which regulates various involuntary, automatic body functions) on inflammation and depression.  The nerve stimulation will be delivered to the skin of the ear (called transcutaneous auricular vagus nerve stimulation -taVNS).  If included, participants will be randomly assigned to receive either active taVNS or sham stimulation for 4 hours daily over a 30-day period. Final testing for safety and for measures of inflammation and depression will be performed after 30 days.","age_from":18,"age_to":null,"ais_a":false,"ais_b":false,"ais_c":false,"ais_d":false,"ais_e":false,"time_since_injury_from":null,"time_since_injury_from_unit":null,"time_since_injury_to":null,"time_since_injury_to_unit":null,"healthy_volunteers":false,"inclusion_criteria":["NOT have a pacemaker or other implanted electrical device (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker)","have mild to moderate measures for depression"],"study_type":"interventional","allocation":"Randomized","brief_description":"Spinal cord injury (SCI) has been shown to be associated with impairment to the autonomic nervous system in the form of reduced activity of a key nerve known as the vagus nerve. As the vagus nerve has an important role in regulating inflammation and is associated with depression, it may represent a key mechanism which contributes to chronic inflammation and depression following SCI.\n\nA technique known as transcutaneous auricular vagus nerve stimulation (taVNS) can stimulate the vagus nerve non-invasively through an electrode applied on the skin of the ear. This technique has been shown to effectively reduce inflammation and improve symptoms of depression in other populations without any serious adverse events. However, it has not been assessed in individuals with SCI.\n\nThe primary objective of this study is to assess the efficacy of taVNS therapy for the treatment of inflammation and depression. Autonomic function as assessed by measures of heart rate variability (HRV) will also be assessed to quantify changes in vagal tone. The study will be conducted over a 2-year period, with 44 individuals with SCI and depression participating. Participants will be randomly assigned to receive either active taVNS or a placebo (sham) treatment over a 30-day period.\n\nThe researchers will assess changes in depression symptoms, autonomic function (heart rate variability), and biomarkers related to inflammation at baseline and 30-days. Safety and adherence will also be evaluated to confirm the feasibility for long-term use.\n\nThis study aims to explore a novel and non-invasive treatment strategy for depression in individuals with spinal cord injury. If taVNS is found to be safe, effective, and feasible for SCI patients, it could offer a simple, cost-effective way to address chronic inflammation and depression in this population.","detailed_description":"- Participants will be randomly assigned to receive either active transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation for 4 hours daily over a 30-day period. \n- taVNS is a technique for stimulating the vagus nerve via surface stimulation on the skin of the ear to influence neural activity. \n- Final testing will be performed after 30 days.","final_testing_performed":"30 days","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":5,"name":"General health","parent_id":null,"icon_name":"general-health"},"sex":"All","injury_level_from":"C1","injury_level_to":"S5","start_date":"2025-01-27","organization":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","benefits":[{"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"}],"injuries":[],"interventions":[{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"}],"outcome_measures":[{"id":174,"name":"Adverse Events (AEs)","short_name":"AEs","pivot":{"trial_id":6879,"outcome_measure_id":174}},{"id":97,"name":"Patient Health Questionnaire-9 (PHQ-9)","short_name":"PHQ-9","pivot":{"trial_id":6879,"outcome_measure_id":97}}],"recovery_mechanisms":[],"published_at":"2025-04-26T16:10:45.000000Z","modified_at":"2025-04-26T16:10:45.000000Z"},"layout":"trial"}},
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