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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

NUVISTA Trial 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.Check my eligibility

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.See study design

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.

NUVISTA Trial 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.

NUVISTA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

NUVISTA 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,936 Previous Clinical Trials

2,299,610 Total Patients Enrolled

23 Trials studying Stroke

76,723 Patients Enrolled for Stroke

Media Library

Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator Clinical Trial Eligibility Overview. Trial Name: NCT05390580 — N/A

Stroke Research Study Groups: Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator, Control - Transcutaneous Auricular Vagal Nerve Stimulator - Sham

Stroke Clinical Trial 2023: Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator Highlights & Side Effects. Trial Name: NCT05390580 — N/A

Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390580 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial encompass individuals aged sixty and above?

"Only individuals aged between 18 and 99 are eligible for this medical trial. For those younger than 18, there are 73 other trials that may be suitable; for seniors over 65, 1258 clinical studies offer potential opportunities to participate."

Answered by AI

What aims is this clinical trial seeking to accomplish?

"The primary aim of this 5-day clinical trial is to observe the difference in Neutrophil to Lymphocyte ratio. Additionally, researchers are also looking at the number and severity of treatment-related adverse events such as Sinus Bradycardia (C54940) and Hypotension (C143352), along with changes in NIH Stroke Scale (NIHSS) scores for participants."

Answered by AI

To what extent has enrollment been reported for this research endeavor?

"Affirmative. Records on clinicaltrials.gov substantiate that this research project, which was initially posted on September 26th 2022, is actively recruiting participants. Approximately 80 volunteers must be gathered from 1 medical centre."

Answered by AI

Are participants being accepted to this trial at present?

"The information found on clinicaltrials.gov confirms that this medical study is actively recruiting volunteers; the trial was posted on September 26th 2022 and its details were last updated a month later, in November 1st 2022."

Answered by AI

Who has been deemed eligible to participate in this clinical investigation?

"This trial is recruiting 80 individuals aged between 18 and 99 who have experienced a cerebrovascular accident. To participant, these people must also meet the following criteria: adult patients with an acute ischemic stroke caused by large vessel blockages."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct

Osvaldo J. Laurido-Soto, MD 2022. "Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05390580.

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