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TaVNS intervention for Stroke (StrokeVNS Trial)

N/A

Recruiting

Led By Elliott Block, MD

Research Sponsored by Casa Colina Hospital and Centers for Healthcare

Eligibility Criteria Checklist

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

Must have

First-time Cerebrovascular Accident (Ischemic or Hemorrhagic)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours before intervention as well as within 24 hours and 6 months after the end of the intervention

Awards & highlights

StrokeVNS Trial Summary

This trial is investigating the use of a non-invasive treatment called transcutaneous auricular vagus nerve stimulation (taVNS) to help improve motor and cognitive recovery in stroke patients. Currently,

Who is the study for?

This trial is for individuals who have had their first stroke within the past month, whether it was ischemic (caused by a blood clot) or hemorrhagic (due to bleeding). It's not suitable for those who've had multiple strokes or other conditions that might interfere with the study.Check my eligibility

What is being tested?

The study is testing transcutaneous vagus nerve stimulation (taVNS), a non-invasive treatment that stimulates the vagus nerve through the skin. Researchers want to see if taVNS can improve motor and cognitive recovery after a stroke by observing changes in brain activity.See study design

What are the potential side effects?

While specific side effects of taVNS are not detailed here, similar treatments may cause mild discomfort at the stimulation site, headache, voice changes, or shortness of breath. Side effects vary from person to person.

StrokeVNS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had a stroke for the first time.

StrokeVNS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 hours before intervention as well as within 24 hours and 6 months after the end of the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 hours before intervention as well as within 24 hours and 6 months after the end of the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours before intervention as well as within 24 hours and 6 months after the end of the intervention for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Fugl-Meyer Assessment - Upper extremity

Resting state electroencephalogram (EEG)

Secondary outcome measures

The Montreal Cognitive Assessment

The modified Rankin Scale

StrokeVNS Trial Design

1Treatment groups

Experimental Treatment

Group I: TaVNS interventionExperimental Treatment1 Intervention

Before starting applying taVNS, patients will be assessed using the FMA-U and the mRS for motor recovery as well as the MOCA for cognitive recovery. Resting state EEG will be recorded with eyes open during 15 minutes using our 64 electrodes cap (actiCHamp Plus; brainproducts.com), just after the behavioral assessment is performed. On the same day, patients will receive taVNS for 45 minutes, during therapy. The stimulation parameters, will be as follows: 250ms square pulses at 20 Hz. The electrical stimulation will given for 45 minutes a day for 10 working days (5 days a week for 2 weeks). The amplitude will be 1.7mA but may be reduced to 1.0mA if the patient is unable to tolerate due to discomfort or pain. After the last taVNS session is applied, outcome measures will be administered again by the research team. A follow-up at 6 months after the end of the last session will be conducted over the phone using the adapted version of the mRS and the MOCA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous vagus nerve stimulation

2020

N/A

~270

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Casa Colina Hospital and Centers for HealthcareLead Sponsor

9 Previous Clinical Trials

279 Total Patients Enrolled

5 Trials studying Stroke

197 Patients Enrolled for Stroke

Foundation for Physical Medicine and RehabilitationOTHER

6 Previous Clinical Trials

244 Total Patients Enrolled

Elliott Block, MDPrincipal InvestigatorCasa Colina Hospital and Centers for Healthcare

Frequently Asked Questions

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

Does the inclusion criteria of this medical study allow for participation by individuals aged 75 and above?

"For this particular clinical trial, individuals aged 18 and above but below 80 are eligible for enrollment based on the inclusion criteria."

Answered by AI

What is the current number of participants eligible for enrollment in this clinical research study?

"Indeed, the available information on clinicaltrials.gov indicates that this trial is actively seeking eligible individuals to participate. The study was first posted and last updated on January 29th, 2024. In total, the trial aims to enroll 22 patients across a single site."

Answered by AI

Are there any ongoing efforts to enroll participants in this current medical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this particular clinical trial is currently in the recruitment phase. The study was first posted on January 29th, 2024 and most recently updated on the same day. They are seeking a total of 22 participants at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Caroline Schnakers 2024. "EEG Changes Related to taVNS in Stroke Patients: a Preliminary Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06226493.

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