NCT07524491

taVNS During Exercise and Recovery in Chronic Spinal Cord Injury

Transcutaneous Auricular Vagus Nerve Stimulation Modulates Autonomic Dynamics During Exercise and Recovery in Chronic Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of the Balearic Islands · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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. Heart 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. This 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. Transcutaneous 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. The 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. Each 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. The 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. This 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.

Conditions

• Spinal Cord Injury, Chronic

Interventions

Type	Name	Description
DEVICE	Transcutaneous Auricular Vagus Nerve Stimulation	Non-invasive electrical stimulation applied to the auricular branch of the vagus nerve using transcutaneous electrodes during the experimental protocol.
DEVICE	Sham Stimulation	Sham stimulation delivered with identical device setup but without effective activation of the vagus nerve.

Timeline

• Start date: 2024-10-31
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Spain