Trial results for a study investigating Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct were posted on ClinicalTrials.gov on 2025-10-31, with 40 participants enrolled.
Background
Acute ischemic stroke, caused by a blockage in a blood vessel supplying the brain, is a leading cause of disability and mortality worldwide. Current accepted management focuses on restoring blood flow and preventing further damage. However, the inflammatory response following an ischemic stroke plays a significant role in secondary brain injury. Exploring adjunctive therapies that can modulate this inflammatory response, such as vagus nerve stimulation, could offer new avenues for improving patient outcomes.
Trial design
This completed pilot study, designated as Phase NA, enrolled 40 participants with Acute Ischemic Stroke. The study was a randomized, open-label trial with blinded outcome assessment. It aimed to evaluate the effect of transcutaneous auricular vagal nerve stimulation (taVNS) on inflammatory laboratory values and to explore clinical outcomes. Participants received either current accepted management alone or accepted management in addition to taVNS. The control group received sham stimulation.
Key results
The trial reported several key measurements related to inflammatory markers and clinical outcomes:
- Interleukin - 1b - Changes and Differences in the Levels (percent change/day):
- Stimulation group: -0.222
- Control (Sham) group: 0.327
- Interleukin - 6 - Changes and Differences in the Levels (percent change/day):
- Stimulation group: -4.099
- Control (Sham) group: 4.323
- Tumor Necrosis Factor Alpha - Changes and Differences in the Levels (percent change/day):
- Stimulation group: -0.244
- Control (Sham) group: -0.120
- White Blood Cell Total Count - Changes and Differences in the Levels (percent change/day):
- Stimulation group: -0.914
- Control (Sham) group: -0.050
- Change in NIH Stroke Scale (NIHSS) (score change/day):
- Stimulation group: -1.613
- Control (Sham) group: -1.562
Key analyses using Mixed Models Analysis to test trajectory differences between taVNS and sham groups reported p-values of 0.24, 0.0001, 0.26, 0.14, 0.69, and 0.48. One analysis showed a statistically significant difference with a p-value of 0.0001, indicating a notable difference in trajectories for certain inflammatory markers or white blood cell counts between the stimulation and sham groups.
What this means
The results from this pilot study suggest that transcutaneous auricular vagal nerve stimulation may have an anti-inflammatory effect in patients with acute ischemic stroke, as indicated by reductions in inflammatory markers like Interleukin-1b, Interleukin-6, Tumor Necrosis Factor Alpha, and White Blood Cell Total Count in the stimulation group compared to the control. One analysis demonstrated a statistically significant difference in the trajectories of these markers. While the change in NIH Stroke Scale (NIHSS) was similar between groups, indicating no immediate differential clinical improvement in this small pilot, the observed impact on inflammatory markers warrants further investigation into taVNS as a potential adjunctive therapy to mitigate the inflammatory response post-stroke.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05390580, titled "Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct", were posted on 2025-10-31 on clinicaltrials.gov.