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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Stroke Pain
• Intervention / Treatment: Device: Transcutaneous Auricular Neurostimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Institutional RBFHR Recruitment Contact; Phone Number: 843-792-9502; Email: suttonf@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • 30 Bee Street
      • Contact: Falon Sutton; Phone Number: 8437929502; Email: suttonf@musc.edu
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • Medical University of South Carolia
      • Contact: Falon Sutton; Phone Number: 843-792-9502; Email: suttonf@musc.edu
      • Principal Investigator: Xiaolong Peng, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80
• Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
• Ischemic or hemorrhagic stroke that occurred at least 6 months prior

Exclusion Criteria:

• Primary intracerebral hematoma or subarachnoid hemorrhage
• Documented history of dementia
• Documented history of uncontrolled depression or psychiatric disorder
• Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) >=180/100mmHg
• Contraindicated for MRI scanning
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 Weeks Sham tAN followed by 2 Weeks Active tAN; Participants will be randomized to receive 2 weeks of at-home, self-administered sham Transcutaneous Auricular Neurostimulation (tAN), followed by 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).	Device: Transcutaneous Auricular Neurostimulation; Transcutaneous Auricular Neurostimulation (tAN) is a wearable, electrical stimulation device that delivers electricity to specific parts of the human ear.
Experimental: Four Weeks of Active Transcutaneous Auricular Neurostimulation; Participants will be randomized to receive 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN), followed by 2 additional weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).	Device: Transcutaneous Auricular Neurostimulation; Transcutaneous Auricular Neurostimulation (tAN) is a wearable, electrical stimulation device that delivers electricity to specific parts of the human ear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Threshold	We will determine the pain threshold with a 30 × 30 mm thermode attached to the non-affected forearm of participants (TSA2 thermode; Medoc, Durham, NC, USA). Using the TSA2, we will determine heat sensitivity beginning at 32°C and increasing by 0.5°C per second. Participants will be asked to press a button (to record temperatures) when the stimulus is first detected (sensory threshold). We will acquire QST data at baseline, after one session (30 minutes) of tAN, after 2 weeks of tAN, and after 4 weeks of tAN.	4 weeks
Pain Threshold	We will determine the pain threshold with a 30 × 30 mm thermode attached to the non-affected forearm of participants (TSA2 thermode; Medoc, Durham, NC, USA). Using the TSA2, we will determine heat sensitivity beginning at 32°C and increasing by 0.5°C per second. Participants will be asked to press a button (to record temperatures) when the stimulus becomes painful (pain threshold). We will acquire QST data at baseline, after one session (30 minutes) of tAN, after 2 weeks of tAN, and after 4 weeks of tAN.	4 weeks
Pain tolerance	We will determine the pain threshold with a 30 × 30 mm thermode attached to the non-affected forearm of participants (TSA2 thermode; Medoc, Durham, NC, USA). Using the TSA2, we will determine heat sensitivity beginning at 32°C and increasing by 0.5°C per second. Participants will be asked to press a button (to record temperatures) when the stimulus is intolerable (pain tolerance). We will acquire QST data at baseline, after one session (30 minutes) of tAN, after 2 weeks of tAN, and after 4 weeks of tAN.	4 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Xiaolong Peng, Ph.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 13, 2025
• First Submitted That Met QC Criteria: August 25, 2025
• First Posted (Actual): August 27, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Stroke
• Other Study ID Numbers: Pro00145968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified imaging, behavioral, and QST data may be shared in aggregate or via secure repositories for future research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No