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

Study Overview
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Brief Summary
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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).

Official Title
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Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients

Conditions
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Acute Stroke

Intervention / Treatment
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* Device: Non-invasive electromagnetic stimulation for acute stroke treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VItalFlow Stimulation Treatment<br>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<br>* Bilateral electromagnetic stimulation to improve blood flow in ischemic regions of acute stroke as an adjunct to current standard-of-care<br>* Other names: VitalFlow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device-related adverse events | Rate of device-related adverse events | 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. | 1-7 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 2-4 hours post-procedure | 
| Exploratory - Difference in baseline core volume on CTP compared to 24 hour MRI final infarct volume | Difference in baseline core volume on CTP compared to 24 hour MRI final infarct volume. Being evaluated for potential use as surrogates in future studies. | 24 hours post-procedure | 
| Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - short-term | Change in NIHSS score [range: 1-42, with lower score indicating better outcome] pre to post-stimulation, and every 30 minutes up to 4 hours post-stimulation. Being evaluated for potential use as surrogates in future studies. | Pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure | 
| Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - 24 hours | Change in NIHSS score [range: 1-42, with lower score indicating better outcome] pre-stimulation to 24 hours post-stimulation, and every 30 minutes up to 4 hours post-stimulation. Being evaluated for potential use as surrogates in future studies. | 24 hours post-procedure | 
| Exploratory - Patient Outcome as determined by National Institute of Health Stroke Scale (NIHSS) | NIHSS score [range: 1-42, with lower score indicating better outcome] at 90 days post-procedure. Being evaluated for potential use as surrogates in future studies. | 90 days post-procedure | 
| Exploratory - Patient Outcome as determined by Modified Rankin Scale (mRS) | mRS score [range: 0-6, with lower score indicating better outcome] at 90 days post-procedure. Being evaluated for potential use as surrogates in future studies. | 90 days post-procedure | 
| Exploratory - Final change in infarct growth - CTP (CBF<30%) at pre-stimulation vs MRI-DWI lesion at 24 hours | Final change in infarct growth - CTP (CBF<30%) at pre-stimulation vs MRI-DWI lesion at 24 hours. Being evaluated for potential use as surrogates in future studies. | 24 hours post-procedure |