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NOT YET RECRUITING
NCT07719868
NA

TaVNS for Capsaicin-Induced Pain

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

Effective pain management remains a major clinical challenge. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising, non-invasive neuromodulation technique due to its safety, ease of administration, and cost-effectiveness. Preliminary evidence suggests that taVNS exerts analgesic effects by activating afferent vagal fibers, which integrate signals in key central nodes such as the nucleus tractus solitarius (NTS). This process subsequently modulates pain-processing networks, neurotransmitter balance, inflammatory responses, and autonomic function. Despite its potential, the precise central neural mechanisms underlying taVNS-induced analgesia remain unclear, limiting the optimization of stimulation parameters (e.g., intensity, frequency, and target specificity) and the enhancement of long-term therapeutic outcomes. Previous studies have highlighted the role of taVNS in activating descending pain inhibitory pathways and modulating the limbic system, yet a comprehensive understanding of the causal neurophysiological dynamics is still lacking. This study aims to investigate the analgesic efficacy of taVNS using a capsaicin-induced pain model. Furthermore, by employing Transcranial Magnetic Stimulation combined with Electroencephalography (TMS-EEG), we seek to elucidate the central neural mechanisms of taVNS. By integrating causal intervention with high-temporal resolution brain activity recording, this research will provide scientific insights into the modulation of pain-related pathways-such as descending inhibitory and cognitive-affective networks-ultimately facilitating the development of standardized, individualized, and precise clinical interventions for pain management.

Official title: Analgesic Efficacy and Neural Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in a Capsaicin-Induced Pain Model

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-07-10

Completion Date

2027-09-10

Last Updated

2026-07-22

Healthy Volunteers

Yes

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

Participants receive taVNS using a percutaneous electrical stimulation device. The stimulation is delivered to the auricular branch of the vagus nerve via two modified punctate electrodes with the following parameters: frequency = 30 Hz, pulse width = 200 μs, duration = 30 minutes.

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

Participants receive sham stimulation via the same device, with parameters set to 0.1 Hz for 30 minutes, designed to provide minimal sensory input that is indistinguishable from the active stimulation to ensure double-blinding.