NCT07144436

Post-stroke Pain tAN-fMRI

Investigating the Feasibility, Efficacy, and Renormalization of Pain-Regulation Brain Circuits Underlying At-Home Transcutaneous Auricular Neuromodulation (tAN) for Managing Chronic Post-Stroke Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• 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 4 weeks of at-home transcutaneous auricular neurostimulation (tAN) can reduce chronic pain after a stroke. Investigators will recruit up to 24 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, the investigators main goal is to establish transcutaneous auricular neurostimulation (tAN) as an effective non-invasive neuromodulation method for pain management of post-stroke pain (PSP) and to investigate the brain circuit changes between pre- and post-treatment in individuals with PSP using brain imaging techniques. Aim 1. Assess the feasibility and efficacy of self-administered, at-home tAN for pain management in stroke survivors with chronic pain compared to sham. Aim 2. Investigate pain-induced brain activity changes over a one-month tAN treatment to understand the analgesic mechanisms of tAN. Aim 3. Explore renormalization of brain functional connectivity and dynamic brain state throughout tAN treatment and develop brain imaging biomarkers to track and predict treatment efficacy for chronic post-stroke pain.

Conditions

• Post Stroke Pain

Interventions

Type	Name	Description
DEVICE	Transcutaneous Auricular Neurostimulation	Transcutaneous Auricular Neurostimulation (tAN) is a wearable, electrical stimulation device that delivers electricity to specific parts of the human ear.

Timeline

• Start date: 2026-01-08
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-08-27
• Last updated: 2026-02-04

Locations

2 sites across 1 country: United States