N/A
Completed N=40
Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct
Source: ClinicalTrials.gov NCT05390580 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Interleukin - 1b - Changes and Differences in the Levels — -0.222; 0.327 percent change/day — p=0.24
Summary
This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagal nerve stimulation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interleukin - 1b - Changes and Differences in the Levels |
-0.222; 0.327 | 0.24 |
| PRIMARY Interleukin - 6 - Changes and Differences in the Levels |
-4.099; 4.323 | 0.0001 sig |
| PRIMARY Tumor Necrosis Factor Alpha - Changes and Differences in the Levels |
-0.244; -0.120 | 0.26 |
| PRIMARY White Blood Cell Total Count - Changes and Differences in the Levels |
-0.914; -0.050 | 0.14 |
| PRIMARY Neutrophil to Lymphocyte Ratio - Changes and Differences in the Levels |
NA; NA | — |
| SECONDARY Change in NIH Stroke Scale (NIHSS) |
-1.613; -1.562 | 0.69 |
| SECONDARY Modified Ranking Scale (mRS) |
3.27; 2.78 | 0.48 |
| SECONDARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 - Hypotension (C143352) |
0; 2 | 0.49 |
| SECONDARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 - Sinus Bradycardia (C54940) |
2; 4 | 0.66 |
Eligibility Criteria
Inclusion Criteria
- Adult patients who present with acute ischemic strokes due to large vessel occlusions
Exclusion Criteria
- 2
- unable to initiate treatment under 36 hours from symptom discovery
- Chronic or severe infection
- life expectancy <3 months
- patients' undergoing active cancer or immunosuppressive/modulating therapy
- patients with sustained bradycardia on arrival with a heart rate <50 beats per minute.
Data sourced from ClinicalTrials.gov (NCT05390580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.