Neuromodulation for Ischemic Stroke
(NUVISTA Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Adults who've had a stroke caused by a blockage in a large blood vessel can join this trial. They must be able to start treatment within 36 hours of noticing symptoms and have no severe infections, life expectancy under 3 months, or slow heart rate on arrival.

Inclusion Criteria

I had a stroke caused by a blockage in a large artery.

Exclusion Criteria

You have a score of less than 6 on the NIH Stroke Scale.

I am currently receiving treatment for cancer or taking drugs that affect my immune system.

I was somewhat independent in daily activities before my current illness.

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Treatment Details

Interventions

Sham transcutaneous vagal nerve stimulation (Sham Device)
transcutaneous auricular vagal nerve stimulation (Neuromodulation Device)

Trial OverviewThe study is testing if adding transcutaneous auricular vagal nerve stimulation to usual stroke care helps reduce inflammation and improve recovery compared to standard care alone. Participants are randomly chosen to receive either the real stimulation or a sham (fake) version.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Stimulation with Transcutaneous Auricular Vagal Nerve StimulatorExperimental Treatment1 Intervention

All patients will be fitted with the device, the investigator will attach adhesive contacts to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period, the investigator will stimulate the auricular branch of the vagus nerve. Patients' will be treated with the following parameters: frequency 20 Hz, pulse width 250 µm, and and a fixed intensity of 0.5 milliampere. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation.

Group II: Control - Transcutaneous Auricular Vagal Nerve Stimulator - ShamPlacebo Group1 Intervention

All patients will be fitted with the device, the investigator will attach adhesive contacts to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients assigned to the controls arm will have electricity applied to the the great auricular nerve (cervical nerve branch), the lobule of the ear. The investigator will stimulate the lobule of the ear. Patients' will be treated with the following parameters: frequency 20 Hz, pulse width 250 µm, and and a fixed intensity of 0.5 milliampere. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation.