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

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801225
• Other study ID #: NV-CP-2020-001
• Secondary ID: 4U44NS094307
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2023
• Source: Nervive, Inc.
• Contact: Stephanie Harrington, MS
• Phone: 440 796-0619
• Email: sharrington[@]nervive.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 31, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	MetroHealth	Cleveland	Ohio
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nervive, Inc.	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of device-related adverse events	Rate of device-related adverse events	90 days post-procedure
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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