At-home ear neurostimulation for chronic post-stroke upper limb pain
Investigating the Feasibility, Efficacy, and Renormalization of Pain-Regulation Brain Circuits Underlying At-Home Transcutaneous Auricular Neuromodulation (tAN) for Managing Chronic Post-Stroke Pain
This study will try daily at-home ear nerve stimulation for people with chronic upper-arm pain after a stroke to see if it lowers their pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 2 sites (Charleston, South Carolina and 1 other locations) |
| Trial ID | NCT07144436 on ClinicalTrials.gov |
What this trial studies
Up to 24 adults with chronic post-stroke upper extremity pain will self-administer transcutaneous auricular neurostimulation (tAN) at home for four weeks and be compared with a sham group. Participants will undergo brain imaging before and after the treatment period to measure pain-related brain activity and connectivity changes. The trial aims to test feasibility and symptom change from at-home tAN while exploring imaging biomarkers that track or predict response. Treatment is non-invasive and self-applied, with clinic visits required for enrollment and MRI scans.
Who should consider this trial
Good fit: Adults aged 18–80 with ischemic or hemorrhagic stroke at least six months earlier who have chronic post-stroke upper extremity pain, can consent in English, and can undergo MRI are the intended candidates.
Not a fit: People with primary intracerebral hematoma or subarachnoid hemorrhage, documented dementia, uncontrolled psychiatric disorders or hypertension, MRI contraindications, or who are pregnant would not be eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could offer a non-drug, non-invasive at-home option to reduce chronic post-stroke upper limb pain.
How similar studies have performed: Small studies of non-invasive auricular nerve stimulation have suggested pain-relief signals, but using tAN specifically for chronic post-stroke pain with MRI biomarker work is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charleston, South Carolina and 1 other locations
- 30 Bee Street — Charleston, South Carolina, United States (Recruiting)
- Medical University of South Carolia — Charleston, South Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Xiaolong Peng, Ph.D. — Medical University of South Carolina
- Study coordinator: Institutional RBFHR Recruitment Contact
- Email: suttonf@musc.edu
- Phone: 843-792-9502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.