Post-stroke Pain tAN-fMRI

NCT ID: NCT07144436

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-30
• Study Completion Date: 2027-06-30

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.

Conditions

Post Stroke Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Transcutaneous Auricular Neurostimulation

Intervention Type: DEVICE

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

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).

Group Type: EXPERIMENTAL

Transcutaneous Auricular Neurostimulation

Intervention Type: DEVICE

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

Interventions

Transcutaneous Auricular Neurostimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Peng

Research Instructor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaolong Peng, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolia

Charleston, South Carolina, United States

Countries

United States

Central Contacts

Institutional RBFHR Recruitment Contact

Role: CONTACT

suttonf@musc.edu

843-792-9502

Facility Contacts

Falon Sutton

Role: primary

suttonf@musc.edu

843-792-9502

Other Identifiers

Pro00145968

Identifier Type: -

Identifier Source: org_study_id