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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

649,380 Total Patients Enrolled

171 Trials studying Stroke

83,848 Patients Enrolled for Stroke

Nervive, Inc.Lead Sponsor

1 Previous Clinical Trials

37 Total Patients Enrolled

Ken Uchino, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

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

Is this investigation including geriatric individuals in its scope?

"This medical trial invites those aged 18 and older, up to the age of 85, to participate."

Answered by AI

What goals is this medical research attempting to achieve?

"This clinical trial, lasting 90 days post-procedure, will principally focus on the Feasibility of device use in the Clinical Environment as assessed by User Survey. Additionally, exploratory objectives encompass assessing Change in core volumes and occlusion status through CTP scans at pre-stimulation vs 2–4 hours post-stimulation; also included is evaluating Patient Outcome as determined by Modified Rankin Scale (mRS) scores at 90 days post-procedure."

Answered by AI

Are enrollment slots currently open for this research project?

"According to information on clinicaltrials.gov, this study is currently recruiting patients. It was initially posted in August of 2022 and the latest update occurred in October of the same year."

Answered by AI

How many subjects are taking part in this research initiative?

"Affirmative. Data housed on clinicaltrials.gov reveals that this experiment, which was purportedly listed on August 24th 2022, is presently in search of participants. The research team has plans to recruit 10 patients across two separate sites."

Answered by AI

Do I meet the requisite criteria to join this medical trial?

"This clinical trial is currently enrolling 10 individuals aged between 18 and 85 years old, suffering from stroke. Additionally, all participants must have had IV rtPA or Endovascular Treatment (EVT) before the start of their participation in this study, with 1.5 hours allotted for pre-stimulation procedures to keep the therapeutic window open at 6 hours."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients

2022. "Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04801225.

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