Acute StrokeNCT04801225
Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients
A study testing Non-invasive electromagnetic stimulation for acute stroke treatment in people with Acute Stroke, run by Nervive, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Non-invasive electromagnetic stimulation for acute stroke treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2022to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MetroHealth
Cleveland, Ohio, 44109
The Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients
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).
- Conditions
- Acute Stroke
- Being tested
- Non-invasive electromagnetic stimulation for acute stroke treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive electromagnetic stimulation for acute stroke treatmentDevice
Also called Nervive VitalFlow Stimulator, VitalFlow
Bilateral electromagnetic stimulation to improve blood flow in ischemic regions of acute stroke as an adjunct to current standard-of-care
| Study group | Role | What they receive |
|---|---|---|
| VItalFlow Stimulation Treatment | Experimental | 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. Receives: Device: Non-invasive electromagnetic stimulation for acute stroke treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device-related adverse events
Rate of device-related adverse events
Measured: 90 days post-procedure
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.
Measured: 1-7 days post-procedure
Secondary outcomes (10)
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.
Measured: 2-4 hours post-procedure
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.
Measured: 2-4 hours post-procedure
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.
Measured: 2-4 hours post-procedure
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.
Measured: 2-4 hours post-procedure
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.
Measured: 24 hours post-procedure
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.
Measured: Pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure
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.
Measured: 24 hours post-procedure
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.
Measured: 90 days post-procedure
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.
Measured: 90 days post-procedure
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.
Measured: 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start24 Aug 2022
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Why it stopped: Company assets sold. NIH NINDS Grant discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nervive, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie Harrington, MS, Study director, Nervive, Inc.Emilio Sacristan, PhD, Study director, Nervive, Inc.Ken Uchino, MD, Principal investigator, The Cleveland ClinicJon Schrock, MD, Principal investigator, MetroHealth System, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801225
- Sponsor's protocol ID
- NV-CP-2020-001
- Other IDs
- 4U44NS094307
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2021
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT04801225
- Acronym / sponsor ID
- NV-CP-2020-001
- Conditions
- Acute Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company assets sold. NIH NINDS Grant discontinued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nervive, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VItalFlow Stimulation Treatment | Experimental | Device: Non-invasive electromagnetic stimulation for acute stroke treatmentEnrolled 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Time last known normal within 4.5 hours of presentation for enrollment
- Age 18-85 years
- Diagnosis of ischemic stroke in the anterior circulation
- NIHSS at baseline 4-20
- Creatinine < 1.7 mg/dL
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive electromagnetic stimulation for acute stroke treatmentAlso: Nervive VitalFlow Stimulator, VitalFlowBilateral electromagnetic stimulation to improve blood flow in ischemic regions of acute stroke as an adjunct to current standard-of-care | Device | VItalFlow Stimulation Treatment |
Primary outcome
Rate of device-related adverse events
Time frame: 90 days post-procedure
Rate of device-related adverse events
Feasibility of device use in the Clinical Environment as assessed by User Survey
Time frame: 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.
10 secondary outcomes
Exploratory - Rate of change in core volume as measured by Computed Tomography Perfusion
Time frame: 2-4 hours post-procedure
Exploratory - Rate of change in penumbra volume as measured by Computed Tomography Perfusion
Time frame: 2-4 hours post-procedure
Exploratory - Rate of change in collateral blood flow as measured by Computed Tomography Perfusion
Time frame: 2-4 hours post-procedure
Exploratory - Rate of change in occlusion status as measured by Computed Tomography Perfusion
Time frame: 2-4 hours post-procedure
Exploratory - Difference in baseline core volume on CTP compared to 24 hour MRI final infarct volume
Time frame: 24 hours post-procedure
Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - short-term
Time frame: Pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure
Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - 24 hours
Time frame: 24 hours post-procedure
Exploratory - Patient Outcome as determined by National Institute of Health Stroke Scale (NIHSS)
Time frame: 90 days post-procedure
Exploratory - Patient Outcome as determined by Modified Rankin Scale (mRS)
Time frame: 90 days post-procedure
Exploratory - Final change in infarct growth - CTP (CBF<30%) at pre-stimulation vs MRI-DWI lesion at 24 hours
Time frame: 24 hours post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Harrington, MS study director
Nervive, Inc.
Emilio Sacristan, PhD study director
Nervive, Inc.
Ken Uchino, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive electromagnetic stimulation for acute stroke treatment in people with Acute Stroke, run by Nervive, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device-related adverse events (time frame: 90 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.