← Back to Search

Electromagnetic Stimulation

Non-invasive electromagnetic stimulation for acute stroke treatment for Stroke

N/A
Recruiting
Led By Ken Uchino, MD
Research Sponsored by Nervive, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure
Awards & highlights

Study Summary

This trialassesses the safety & function of a device to treat stroke patients, paving the way for a pivotal trial & eventual PMA approval.

Eligible Conditions
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of device use in the Clinical Environment as assessed by User Survey
Rate of device-related adverse events
Secondary outcome measures
Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - 24 hours
Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - short-term
Exploratory - Difference in baseline core volume on CTP compared to 24 hour MRI final infarct volume
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: VItalFlow Stimulation TreatmentExperimental Treatment1 Intervention
Enrolled subjects shall receive a VitalFlow stimulation after other standard-of-care treatments are initiated. VitalFlow treatment is initiated by powering on the System and positioning the two (Left and Right) VItalFlow coils on each side of the head (by the ear). The operator controls the VItalFlow Stimulation through the accompanying console with simple button operation. Once treatment is initiated, the VitalFlow provides continuous, biphasic pulses at a preset power cycle with the total treatment time under 5 min (fixed time). After treatment is completed, the coils are removed and replaced on the VitalFlow System.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,347 Previous Clinical Trials
650,754 Total Patients Enrolled
172 Trials studying Stroke
84,098 Patients Enrolled for Stroke
Nervive, Inc.Lead Sponsor
1 Previous Clinical Trials
37 Total Patients Enrolled
Ken Uchino, MDPrincipal InvestigatorThe Cleveland Clinic
~4 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top