← Back to Search

Neuromodulation for Ischemic Stroke (NUVISTA Trial)

N/A

Recruiting

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients who present with acute ischemic strokes due to large vessel occlusions

Be older than 18 years old

Must not have

Patients undergoing active cancer or immunosuppressive/modulating therapy

Pre-morbid modified Rankin score (mRS) >2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Summary

This trialstudies if a new treatment helps stroke patients with blocked blood vessels & reduce inflammation.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, dizziness, or changes in heart rate. Since it's non-invasive and uses low-level electrical currents, serious side effects are not common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I am currently dealing with a chronic or severe infection.

Select...

I have long-term blockages in my large blood vessels.

Select...

I am under 18 years old.

Select...

My heart rate is consistently below 50 beats per minute.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interleukin - 1b - Changes and differences in the levels

Interleukin - 6 - Changes and differences in the levels

Neutrophil to lymphocyte ratio - Changes and differences in the levels

+2 more

Secondary study objectives

Change in NIH Stroke Scale (NIHSS)

Modified Ranking Scale (mRS)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 - Hypotension (C143352)

+1 more

Trial Design

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.

0 / 7Eligibility criteria met