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

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

No Placebo-Only Group

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

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

Primary study objectives

Feasibility of device use in the Clinical Environment as assessed by User Survey

Rate of device-related adverse events

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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