Post-stroke Pain taVNS

Last updated: August 5, 2025
Sponsor: Medical University of South Carolina
Overall Status: Completed

Phase

N/A

Condition

Pain

Stroke

Cerebral Ischemia

Treatment

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Sham Auricular Stimulation

Clinical Study ID

NCT06456385
Pro00137146
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way participants perceive pain. Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-80

  • Have the capacity and ability to provide one's own consent in English and sign theinformed 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

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 BloodPressure) / DBP (Diastolic Blood Pressure) >=180/100mmHg

  • Pregnancy

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Phase:
Study Start date:
June 04, 2024
Estimated Completion Date:
September 26, 2024

Study Description

In this study, investigators main goal is to establish transcutaneous auricular vagus nerve stimulation (taVNS) as an effective non-invasive neuromodulation method for analgesia of post-stroke upper extremity pain. Participants are required to have an ischemic or hemorrhagic stroke that occurred at least 6 months prior and are currently suffering upper extremity pain. Each participant will undergo an in-person visit. Participants will first finish the pain questionnaires and have quantitative sensory testing (QST) conducted to determine baseline pain thresholds. Participants will then receive 30 minutes of taVNS (either active or sham). Upon the completion of the stimulation intervention, participants will then be tested for another QST and pain questionnaires.

Aim 1: Test the safety and feasibility of taVNS in participants with chronic post-stroke upper extremity pain.

Over the last 8 years, investigators have demonstrated that taVNS is safe and feasible in several different populations in our previous studies. Specifically, investigators have demonstrated that taVNS is well tolerated and safe for participants with chronic stroke in our previous clinical trial. In this study, investigators will further verify the safety and feasibility of taVNS in the population with chronic post-stroke upper extremity pain.

Aim 2: Investigate whether taVNS can modulate pain in this population compared to sham.

In this single-visit, double-blinded, sham-controlled pilot trial, investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from QST before and after a 30-minute taVNS intervention, as well as between active and sham taVNS. The findings will help investigators understand whether taVNS can modulate pain in this population.

Connect with a study center

  • Medical University of South Carolina Institute of Psychiatry

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina Institute of Psychiatry

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

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