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

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

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 Overview

• Status: Withdrawn
• Conditions: Acute Stroke
• Intervention / Treatment: Device: Non-invasive electromagnetic stimulation for acute stroke treatment

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Cleveland, Ohio, United States, 44109
      • MetroHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nervive, Inc.
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Study Director: Stephanie Harrington, MS, Nervive, Inc.; Study Director: Emilio Sacristan, PhD, Nervive, Inc.; Principal Investigator: Ken Uchino, MD, The Cleveland Clinic; Principal Investigator: Jon Schrock, MD, MetroHealth System, Ohio

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 13, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: NV-CP-2020-001; 4U44NS094307 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes