Post-stroke Pain tAN-fMRI

NCT07144436 | Recruiting DMC

• 1 other identifier: Pro00145968
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Stroke Pain

Keywords

Pain; Stroke

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

2 Weeks Sham tAN followed by 2 Weeks Active tAN

EXPERIMENTAL

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

Four Weeks of Active Transcutaneous Auricular Neurostimulation

EXPERIMENTAL

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

Interventions

Transcutaneous Auricular Neurostimulation DEVICE

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

2 Weeks Sham tAN followed by 2 Weeks Active tAN; Four Weeks of Active Transcutaneous Auricular Neurostimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

30 Bee Street

Charleston, South Carolina, 29425, United States

RECRUITING

Medical University of South Carolia

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Pain; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiaolong Peng, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Institutional RBFHR Recruitment Contact

CONTACT

843-792-9502; suttonf@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Instructor-Faculty

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 27, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)