Post-stroke Pain tAN-fMRI

Not Applicable

Not yet recruiting

• Conditions: Post Stroke Pain

• Registration Number: NCT07144436
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Study Start: 2025-09-20
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Sensory Threshold	4 weeks	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.
Pain tolerance	4 weeks	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.
Pain Threshold	4 weeks	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.

Trial Locations

Locations (1)

Medical University of South Carolia; 🇺🇸 Charleston, South Carolina, United States