Non-invasive ear stimulation for pain relief after stroke
Investigate the Anti-pain Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Patients With Chronic Post-stroke Upper Extremity Pain
NA · Medical University of South Carolina · NCT06456385
This study tests if a new non-invasive ear stimulation technique can help stroke survivors with chronic arm pain feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06456385 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on chronic upper extremity pain in stroke survivors. Up to 20 participants who have experienced a stroke at least six months prior will be recruited to assess the safety and feasibility of taVNS as a non-invasive pain management technique. Participants will undergo pain assessments before and after a 30-minute session of either active or sham stimulation to evaluate changes in pain perception. The study aims to establish taVNS as a viable option for alleviating post-stroke pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have experienced an ischemic or hemorrhagic stroke at least six months prior and suffer from right upper extremity pain.
Not a fit: Patients with a history of uncontrolled psychiatric disorders, severe hypertension, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, non-invasive method for managing chronic pain in stroke survivors.
How similar studies have performed: Previous studies have shown that taVNS is safe and feasible in various populations, suggesting potential for success in this specific application.
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 * Unilateral stroke lesions in the left hemisphere * Right upper extremity pain 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 * Pregnancy
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina Institute of Psychiatry — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Xiaolong Peng, PhD
- Email: pengxi@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.