N/A N=40 Randomized Single-blind Treatment

Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct

Acute Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT05390580 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Interleukin - 1b - Changes and Differences in the Levels — -0.222; 0.327 percent change/day — p=0.24

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: transcutaneous auricular vagal nerve stimulation (Device); Sham transcutaneous vagal nerve stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Aug 2024

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

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.

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.

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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.