Transauricular Vagal Nerve Stimulation and Interoception

Pain, Acute Clinical Trial

Official title: Effects of Transauricular Vagal Nerve Stimulation on Interoceptive Channels in Healthy Subjects

Status Recruiting

Clinical Trial Summary

The study is exploring whether, and for how long, taVNS may modulate deep muscular pressure pain thresholds, heartbeat, and thermal perception (Ethics Region Nord Jylland Denmark, N-20230022). To achieve this, 20 healthy subjects will complete a randomized, active control, crossover study. The main intervention is left concha taVNS (NEMOS, CerboMed GmbH, Erlangen, Germany) for 20 minutes (200µs duration, 20Hz, at a personalized intensity). This will be compared to an active control of identical electrical stimulation to the left earlobe. A blinding assessment inquiring which stimulation is supposed to be therapeutic will be collected. Main outcomes are pressure pain thresholds and temporal summation of pain responses acquired via cuff-pressure algometer (Cortex Technology, Aalborg University, Denmark) placed at the calf. Heartbeat perception, assessed via the heartbeat counting task, and thermal perception, assessed using a QST thermal grid, are also primary outcomes. Secondary outcomes are conditioned pain modulation, resting state electroencephalography, electrocardiography, and pupillary light reflexes.

Clinical Trial Description

Interoception, the ability to perceive, process and respond to signals originating from within the body, is crucial for maintaining healthy physiological ranges. Indeed, dysfunction in this ability has been associated with various mood and pain disorders. Based on the overlap between the anatomical pathway of this ability and the site of action of the tool, transauricular vagal nerve stimulation (tVNS) could modulate this interoception. However, little is known about the breadth, duration, and mechanism of interoception modulation by taVNS.

The current study will address these limitations, with a focus on three interoceptive channels: deep muscular pressure pain, heartbeat, and thermal perception. Specifically, 20 healthy subjects will complete a randomized, active control, crossover study containing two stimulation sessions.

The main intervention is left concha taVNS (NEMOS, CerboMed GmbH, Erlangen, Germany) for 20 minutes (200µs duration, 20Hz, at a personalized intensity). The active control will be identical electrical stimulation to the left earlobe. To assess blinding, a questionnaire inquiring which stimulation is supposed to be therapeutic will be collected at the end of the study.

Main outcomes are pressure pain thresholds and temporal summation of pain responses acquired via cuff-pressure algometer (Cortex Technology, Aalborg University, Denmark) placed at the calf. Heartbeat perception, assessed via the heartbeat counting task, and thermal perception, assessed using a QST thermal grid, are also primary outcomes. Secondary outcomes are conditioned pain modulation, resting state electroencephalography, electrocardiography, and pupillary light reflexes.

To assess whether, and how, taVNS modulates deep muscular pressure pain, heartbeat, and thermal perception, primary and secondary measurements pre and post stimulation will be collected and compared. To assess the duration of the potential effects, these outcomes will be collected, and compared, at 15min intervals until the primary measurements are within 30% of baseline values. Given baseline is recovered, the second stimulation session will take place. Given this has not occurred within 1.5h of the cessation of the stimulation in the first stimulation session, subjects will be asked to come back at their earliest convenience. ;

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

• NCT number: NCT06240026
• Study type: Interventional
• Source: Aalborg University
• Contact: Laura De Herde, MSc.
• Phone: 93889540
• Email: lauramrdh@hst.aau.dk
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Completion date: May 2024