NCT06456385

Post-stroke Pain taVNS

Investigate the Anti-pain Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Patients With Chronic Post-stroke Upper Extremity Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way participants perceive pain. Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.

Detailed description

In this study, investigators main goal is to establish transcutaneous auricular vagus nerve stimulation (taVNS) as an effective non-invasive neuromodulation method for analgesia of post-stroke upper extremity pain. Participants are required to have an ischemic or hemorrhagic stroke that occurred at least 6 months prior and are currently suffering upper extremity pain. Each participant will undergo an in-person visit. Participants will first finish the pain questionnaires and have quantitative sensory testing (QST) conducted to determine baseline pain thresholds. Participants will then receive 30 minutes of taVNS (either active or sham). Upon the completion of the stimulation intervention, participants will then be tested for another QST and pain questionnaires. Aim 1: Test the safety and feasibility of taVNS in participants with chronic post-stroke upper extremity pain. Over the last 8 years, investigators have demonstrated that taVNS is safe and feasible in several different populations in our previous studies. Specifically, investigators have demonstrated that taVNS is well tolerated and safe for participants with chronic stroke in our previous clinical trial. In this study, investigators will further verify the safety and feasibility of taVNS in the population with chronic post-stroke upper extremity pain. Aim 2: Investigate whether taVNS can modulate pain in this population compared to sham. In this single-visit, double-blinded, sham-controlled pilot trial, investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from QST before and after a 30-minute taVNS intervention, as well as between active and sham taVNS. The findings will help investigators understand whether taVNS can modulate pain in this population.

Conditions

• Stroke
• Pain

Interventions

Type	Name	Description
DEVICE	Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)	The intervention applied is called transcutaneous auricular vagus nerve stimulation (taVNS) which administers electrical stimulation at the ear which targets the auricular branch of the vagus nerve.
DEVICE	Sham Auricular Stimulation	The sham auricular stimulation administers electrical stimulation at the ear lobe which has less auricular branch of the vagus nerve.

Timeline

• Start date: 2024-06-04
• Primary completion: 2024-09-26
• Completion: 2024-09-26
• First posted: 2024-06-13
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study