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

NCT04801225 | Withdrawn DMC FDA Device

• 2 other identifiers: NV-CP-2020-0014U44NS094307
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

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

  2-4 hours post-procedure

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

  2-4 hours post-procedure

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

  2-4 hours post-procedure

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

  2-4 hours post-procedure

• Exploratory - Difference in baseline core volume on CTP compared to 24 hour MRI final infarct volume

  24 hours post-procedure

Study Arms (1)

VItalFlow Stimulation Treatment

EXPERIMENTAL

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

Interventions

Non-invasive electromagnetic stimulation for acute stroke treatment DEVICE

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

Also known as: Nervive VitalFlow Stimulator, VitalFlow

VItalFlow Stimulation Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nervive, Inc.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

MetroHealth

Cleveland, Ohio, 44109, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephanie Harrington, MS

  Nervive, Inc.

  STUDY DIRECTOR

• Emilio Sacristan, PhD

  Nervive, Inc.

  STUDY DIRECTOR

• Ken Uchino, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Jon Schrock, MD

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 16, 2021
• Study Start: August 24, 2022
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)