Post-stroke Pain tAN-fMRI

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Post Stroke Pain

Treatments: Device: Transcutaneous Auricular Neurostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07144436

Pro00145968

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

2 Weeks Sham tAN followed by 2 Weeks Active tAN

Experimental group

Description:

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).

Treatment:

Device: Transcutaneous Auricular Neurostimulation

Four Weeks of Active Transcutaneous Auricular Neurostimulation

Experimental group

Description:

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).

Treatment:

Device: Transcutaneous Auricular Neurostimulation