Acute Stroke
Conditions
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).
Interventions
DEVICENon-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
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Nervive, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device-related adverse events | 90 days post-procedure | Rate of device-related adverse events |
| Feasibility of device use in the Clinical Environment as assessed by User Survey | 1-7 days post-procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Exploratory - Rate of change in core volume as measured by Computed Tomography Perfusion | 2-4 hours post-procedure | 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 | 2-4 hours post-procedure | 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 | 2-4 hours post-procedure | 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 | 2-4 hours post-procedure | 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 | 24 hours post-procedure | 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 | Pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure | 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 | 24 hours post-procedure | 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) | 90 days post-procedure | 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) | 90 days post-procedure | 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 | 24 hours post-procedure | 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. |
Countries
United States
Outcome results
None listed