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

Primary Purpose

Acute Stroke

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Non-invasive electromagnetic stimulation for acute stroke treatment

About this trial

This is an interventional treatment trial for Acute Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

MetroHealthRecruiting
The Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VItalFlow Stimulation Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of device-related adverse events

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04801225

First Posted

March 4, 2021

Last Updated

February 14, 2023

Sponsor

Nervive, Inc.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT04801225

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 24, 2022 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nervive, Inc.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VItalFlow Stimulation Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Non-invasive electromagnetic stimulation for acute stroke treatment

Other Intervention Name(s)

Nervive VitalFlow Stimulator, VitalFlow

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of device-related adverse events

Description

Rate of device-related adverse events

Time Frame

90 days post-procedure

Title

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

Description

Time Frame

1-7 days post-procedure

Secondary Outcome Measure Information:

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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.

Time Frame

2-4 hours post-procedure

Title

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

Description

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.

Time Frame

24 hours post-procedure

Title

Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - short-term

Description

Time Frame

Pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure

Title

Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - 24 hours

Description

Time Frame

24 hours post-procedure

Title

Exploratory - Patient Outcome as determined by National Institute of Health Stroke Scale (NIHSS)

Description

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.

Time Frame

90 days post-procedure

Title

Exploratory - Patient Outcome as determined by Modified Rankin Scale (mRS)

Description

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.

Time Frame

90 days post-procedure

Title

Exploratory - Final change in infarct growth - CTP (CBF<30%) at pre-stimulation vs MRI-DWI lesion at 24 hours

Description

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.

Time Frame

24 hours post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephanie Harrington, MS

Phone

440 796-0619

sharrington@nervive.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jaclyn Fickert, BS

Phone

419 852-6587

jfickert@nervive.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie Harrington, MS

Organizational Affiliation

Nervive, Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Emilio Sacristan, PhD

Organizational Affiliation

Nervive, Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ken Uchino, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jon Schrock, MD

Organizational Affiliation

MetroHealth, Ohio

Official's Role

Principal Investigator

Facility Information:

Facility Name

MetroHealth

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julie Nichols

jnichols@metrohealth.org

First Name & Middle Initial & Last Name & Degree

Jon Schrock, MD

Facility Name

The Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emily Fisher

fishere3@ccf.org

First Name & Middle Initial & Last Name & Degree

Ken Uchino, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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