Trial results for a study investigating transcutaneous auricular vagus nerve stimulation (taVNS) for Stroke and Pain were posted on ClinicalTrials.gov on 2025-08-22, involving 15 participants. The study explored whether this non-invasive ear stimulation could alter pain perception in individuals with chronic post-stroke upper extremity pain.
Background
Chronic pain following a stroke, particularly in the upper extremities, can significantly impair a patient's quality of life and functional recovery. Current management strategies often involve a combination of pharmacological and non-pharmacological approaches, but effective and well-tolerated treatments remain an area of ongoing research. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that involves delivering electrical impulses to the auricular branch of the vagus nerve, which has been explored for its potential role in pain modulation and other neurological conditions.
Trial design
This completed study, identified as Phase NA, enrolled 15 participants with Stroke and Pain, specifically chronic post-stroke upper extremity pain. The trial's purpose was to determine if there was a pain reduction after ear stimulation. The intervention involved transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive form of ear stimulation, compared against a sham stimulation.
Key results
The trial measured thermal pain threshold and subjective pain ratings across both active and sham stimulation groups:
- For Thermal Pain Threshold in the Auricular Neurostimulation (Active) group, the mean was 41.84 Celsius with a Standard Deviation of 5.14.
- For Thermal Pain Threshold in the Auricular Neurostimulation (Sham) group, the mean was 42.51 Celsius with a Standard Deviation of 2.66.
- For Subjective Pain Ratings in the Auricular Neurostimulation (Active) group, the mean was 4.00 on a 0-10 scale with a Standard Deviation of 2.45.
- For Subjective Pain Ratings in the Auricular Neurostimulation (Sham) group, the mean was 3.57 on a 0-10 scale with a Standard Deviation of 2.30.
What this means
The posted results indicate that transcutaneous auricular vagus nerve stimulation (taVNS) did not demonstrate a clear beneficial effect on thermal pain threshold or subjective pain ratings compared to sham stimulation in this small cohort of post-stroke pain patients. The active group showed a slightly lower mean thermal pain threshold (meaning less tolerance to heat) and slightly higher subjective pain ratings compared to the sham group. Given the enrollment of only 15 participants, these findings suggest that further research with larger cohorts may be needed to conclusively determine the efficacy of taVNS for chronic post-stroke upper extremity pain.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06456385, titled "Post-stroke Pain taVNS", were posted on 2025-08-22 on clinicaltrials.gov.