Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients
Key facts
- Who runs it
- Nervive, Inc.
- Where
- Cleveland, United StatesSee the 2 sites
- Trial code
- Status
- Withdrawn
- Started
- 24 Aug 2022
- Ended
- 15 Apr 2025
- Type of study
- Interventional
- Treatments tested
- Non-invasive electromagnetic stimulation for acute stroke treatment
- Record updated
- 18 April 2025
- Why it stopped
- Company assets sold. NIH NINDS Grant discontinued.
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- Pre-stroke disability Modified Rankin Score (mRS) between 2-6
- Neuroimaging with intracranial hemorrhage, severe brain edema, or ASPECTS <5
- Intracranial mass lesion, infection, or other reason to suspect increased intracranial pressure
- Cardiac, vagal nerve, or intracranial neural stimulation device
- History of neuropathy (including facial nerve injury), carotid surgery, or vagotomy
- Inability to communicate sufficiently to participate in study procedures
- Known or newly-discovered aneurysm or arteriovenous malformation (AVM)
- Metallic foreign bodies or implanted devices in the head or neck, including tattoos
Where in United States
- MetroHealthCleveland, United StatesNo longer taking part
- The Cleveland ClinicCleveland, United StatesNo longer taking part
About the trial
What the trial wants to find out
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).
The group in the trial
- VItalFlow Stimulation TreatmentTreatment being tested
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.
Treatment: Non-invasive electromagnetic stimulation for acute stroke treatment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients
- Record updated
- 18 April 2025