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

Nervive, Inc.

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Acute Stroke

Interventions

Non-invasive electromagnetic stimulation for acute stroke treatmentDEVICE

Bilateral electromagnetic stimulation to improve blood flow in ischemic regions of acute stroke as an adjunct to current standard-of-care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (2)

MetroHealth

Cleveland, Ohio, United States

The Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Rate of device-related adverse events

Time frame: 90 days post-procedure

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

To demonstrate feasibility, device must have been able to be setup, deployed, and administer treatment without significant difficulty for each study subject, as recorded by the Investigator on the User Survey.

Time frame: 1-7 days post-procedure

Secondary Outcomes

Exploratory - Rate of change in core volume as measured by Computed Tomography Perfusion

Change in core volumes as measured by CTP at pre-stimulation vs 2-4 hours post-stimulation. Being evaluated for potential use as surrogates in future studies.

Time frame: 2-4 hours post-procedure

Exploratory - Rate of change in penumbra volume as measured by Computed Tomography Perfusion

Change in penumbra volume as measured by CTP at pre-stimulation vs 2-4 hours post-stimulation. Being evaluated for potential use as surrogates in future studies.

Time frame: 2-4 hours post-procedure

Exploratory - Rate of change in collateral blood flow as measured by Computed Tomography Perfusion

Change in collateral blood flow as measured by CTP at pre-stimulation vs 2-4 hours post-stimulation. Being evaluated for potential use as surrogates in future studies.

Time frame: 2-4 hours post-procedure

Exploratory - Rate of change in occlusion status as measured by Computed Tomography Perfusion

Change in occlusion status as measured by CTP at pre-stimulation vs 2-4 hours post-stimulation. Being evaluated for potential use as surrogates in future studies.

Data from ClinicalTrials.gov

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