An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Sham Auricular Stimulation in Stroke and Pain, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Exclusion Criteria:
Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus.
Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Participants will receive auricular stimulation of 15Hz on their earlobe.
Device: Sham Auricular Stimulation
The intervention applied is called transcutaneous auricular vagus nerve stimulation (taVNS) which administers electrical stimulation at the ear which targets the auricular branch of the vagus nerve.
The sham auricular stimulation administers electrical stimulation at the ear lobe which has less auricular branch of the vagus nerve.
Thermal Pain Threshold
Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants.
Time frame: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported
Subjective Pain Ratings
Participants will rate their post-stroke upper extremity pain intensity before and after the taVNS using a standard numeric pain rating scale (from minimum 0 to maximum 10, higher scores mean more pain).
Time frame: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported
| Milestone | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) |
|---|---|---|
| Started | 7 | 8 |
| Completed | 7 | 8 |
| Not completed | 0 | 0 |
Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants.
| Celsius | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) |
|---|---|---|
| Thermal Pain Threshold | 41.84 ± 5.14 | 42.51 ± 2.66 |
Participants will rate their post-stroke upper extremity pain intensity before and after the taVNS using a standard numeric pain rating scale (from minimum 0 to maximum 10, higher scores mean more pain).
| Scale 0-10 | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) |
|---|---|---|
| Subjective Pain Ratings | 4.00 ± 2.45 | 3.57 ± 2.30 |
Collected over up to 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Auricular Neurostimulation (Active) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Auricular Neurostimulation (Sham) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(year) | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) | Total |
|---|---|---|---|
| Mean | 51.43 ± 9.88 | 61.38 ± 8.43 | 56.73 ± 10.79 |
| Sex: Female, Male(Participants) | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 1 | 4 | 5 |
| Race (NIH/OMB)(Participants) | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 3 | 8 |
| White | 1 | 5 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| QST Thermal Pain Threshold(Celsius) | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) | Total |
|---|---|---|---|
| Mean | 40.59 ± 4.51 | 43.01 ± 2.44 | 41.8 ± 3.75 |
| Subject Pain Rating(scale 0-10) | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) | Total |
|---|---|---|---|
| Mean | 4.57 ± 2.23 | 4.14 ± 2.61 | 4.36 ± 2.34 |
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Medical University of South Carolina