Status:
WITHDRAWN
Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients
Lead Sponsor:
Nervive, Inc.
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Acute Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04801225
Start Date
August 24 2022
End Date
April 15 2025
Last Update
April 18 2025
Active Locations (2)
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1
MetroHealth
Cleveland, Ohio, United States, 44109
2
The Cleveland Clinic
Cleveland, Ohio, United States, 44195