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

Purpose

This Early Feasibility Study (EFS) is a multi-center, open-label single-arm study in 10 acute ischemic stroke (AIS) patients treated with VitalFlow-IS stimulation within 6 hours of symptom onset. The purpose of the EFS is to evaluate initial clinical safety and device functionality in the clinical workflow setting for treatment of acute ischemic stroke patients that will inform design modifications and/or user interface in preparation for next steps consisting of (1) a full safety/feasibility clinical study and (2) randomized controlled pivotal trial with a surrogate endpoint (expedited Premarket Approval (PMA) pathway).

Condition

  • Acute Stroke

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Time last known normal within 4.5 hours of presentation for enrollment - Allows 1.5 hours for pre-stimulation study procedures to maintain a 6-hour therapeutic window - IV rtPA and Endovascular Treatment (EVT) permissible if not inappropriately delayed by study procedures - Age 18-85 years - Diagnosis of ischemic stroke in the anterior circulation - NIHSS at baseline 4-20 - Creatinine < 1.7 mg/dL - Signed informed consent by patient/Legally Authorized Representative (LAR)

Exclusion Criteria

  • Pre-stroke disability Modified Rankin Score (mRS) between 2-6 - Inability to communicate sufficiently to participate in study procedures - Neuroimaging with intracranial hemorrhage, severe brain edema, or ASPECTS <5 - Known or newly-discovered aneurysm or arteriovenous malformation (AVM) - Intracranial mass lesion, infection, or other reason to suspect increased intracranial pressure - Metallic foreign bodies or implanted devices in the head or neck, including tattoos - Cardiac, vagal nerve, or intracranial neural stimulation device - Cochlear implant or implanted hearing aid - Potential for delay in intravenous rtPA or endovascular therapy due to study procedures - Intravenous (IV) rtPA: Stimulation might be delivered during the rtPA infusion period - EVT: Stimulation might be performed while EVT team is mobilized - Seizure concurrent to stroke, or history of seizures, epilepsy, or recurrent syncopal events. - History of neuropathy (including facial nerve injury), carotid surgery, or vagotomy.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VItalFlow Stimulation Treatment 		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.
  • Device: Non-invasive electromagnetic stimulation for acute stroke treatment
    Bilateral electromagnetic stimulation to improve blood flow in ischemic regions of acute stroke as an adjunct to current standard-of-care
    Other names:
    • Nervive VitalFlow Stimulator
    • VitalFlow

Recruiting Locations

MetroHealth
Cleveland, Ohio 44109
Contact:
Julie Nichols
jnichols@metrohealth.org

More Details

Status
Recruiting
Sponsor
Nervive, Inc.

Study Contact

Stephanie Harrington, MS
440 796-0619
sharrington@nervive.com