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    "path": "/trials/NCT07524491",
    "result": {"pageContext":{"pagePath":"/trials/NCT07524491","trial":{"nct_id":"NCT07524491","brief_title":"taVNS During Exercise and Recovery in Chronic Spinal Cord Injury","official_title":"Transcutaneous Auricular Vagus Nerve Stimulation Modulates Autonomic Dynamics During Exercise and Recovery in Chronic Spinal Cord Injury","about_trial":"This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic cardiovascular regulation during exercise and recovery in individuals with chronic spinal cord injury (SCI). Participants undergo two experimental conditions (active taVNS and sham stimulation) in a randomized crossover design while performing a standardized exercise protocol.\n\nHeart rate variability (HRV) is used as a non-invasive biomarker to assess autonomic nervous system dynamics across different phases (baseline, exercise, and recovery). The aim is to characterize physiological responses to neuromodulation and explore whether taVNS modulates autonomic adaptability in this population.\n\nThis is a mechanistic physiological study designed to improve the understanding of autonomic regulation in SCI and to explore potential biomarkers of response to neuromodulation.","age_from":18,"age_to":70,"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":null,"study_type":"interventional","allocation":"Randomized","brief_description":"This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic cardiovascular regulation during exercise and recovery in individuals with chronic spinal cord injury (SCI). Participants undergo two experimental conditions (active taVNS and sham stimulation) in a randomized crossover design while performing a standardized exercise protocol.\n\nHeart rate variability (HRV) is used as a non-invasive biomarker to assess autonomic nervous system dynamics across different phases (baseline, exercise, and recovery). The aim is to characterize physiological responses to neuromodulation and explore whether taVNS modulates autonomic adaptability in this population.\n\nThis is a mechanistic physiological study designed to improve the understanding of autonomic regulation in SCI and to explore potential biomarkers of response to neuromodulation.","detailed_description":"Spinal cord injury (SCI) is associated with significant impairments in autonomic nervous system function, particularly affecting cardiovascular regulation. These alterations reduce physiological adaptability to internal and external stressors and may contribute to increased cardiovascular risk.\n\nTranscutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that has been proposed as a potential tool to influence autonomic function. However, its effects on dynamic autonomic regulation during physiological stress, such as exercise, remain insufficiently characterized in individuals with SCI.\n\nThe present study is a randomized, controlled, crossover experimental protocol designed to investigate the acute effects of taVNS on autonomic cardiovascular dynamics during a structured exercise and recovery paradigm. Participants with chronic SCI are exposed to two conditions: active taVNS and sham stimulation, applied in a randomized order.\n\nEach experimental session includes three phases: baseline (rest), exercise (submaximal effort), and recovery. Continuous electrocardiographic recordings are obtained to derive heart rate variability (HRV) metrics. Both linear (time and frequency domain) and non-linear analyses are performed to characterize autonomic regulation and system dynamics.\n\nThe primary objective is to evaluate whether taVNS modulates autonomic responsiveness and adaptability across different physiological states. Secondary objectives include the exploration of HRV-derived biomarkers that may reflect autonomic complexity and the identification of response patterns to neuromodulation.\n\nThis study is not designed to evaluate clinical efficacy or therapeutic outcomes but to provide mechanistic insight into autonomic regulation and neuromodulation effects in SCI. The results may contribute to the development of personalized approaches in neurorehabilitation and autonomic monitoring.","final_testing_performed":"0 days","version_id":2,"emsci_trial":false,"curation_status":"uncurated","overall_recruitment_status":"ended","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":"2024-10-31","organization":"University of the Balearic Islands","benefits":[{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"}],"injuries":[],"interventions":[{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"}],"outcome_measures":[],"recovery_mechanisms":[],"published_at":"2026-05-05T14:02:36.000000Z","modified_at":"2026-05-05T14:02:36.000000Z"},"layout":"trial"}},
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