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| Name | Class |
|---|---|
| Turkish Neurological Society | UNKNOWN |
| ElectroCore INC | INDUSTRY |
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This study aims to determine safety and feasibility of non-invasive transcutaneous cervical Vagus nerve stimulation (nVNS) when delivered promptly after clinical diagnosis of acute stroke. Vagus nerve stimulation will be performed via GammaCore® device. A total of 60 patients will be randomized to each of 3 different groups; 'standard dose' vagal stimulation, 'high dose' vagal stimulation, and 'sham stimulation' (1:1:1 ratio). Adverse device events, serious adverse device events, and feasibility of vagal nerve stimulation at the setting of acute stroke will be evaluated. The study will be performed in a multi-center fashion among stroke centers within TurkStrokeNet Network.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose vagal stimulation | Active Comparator | A total of 7 consecutive 2-minute trains at every 10 minutes for one hour (n=20) |
|
| High dose vagal stimulation | Active Comparator | A total of 7 consecutive 2-minute trains applied at every 10 minutes for one hour that is followed by an additional 7 consecutive 2-minute trains interspersed at every 10 minutes applied 3 hours after completion of the initial scheme (n=20) |
|
| Sham stimulation | Sham Comparator | A total of 7 consecutive 2-minute trains at every 10 minutes for one hour (n=20) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gammacore device | Device | Transcutaneous stimulation of vagus nerve with the device positioned below the mandibular angle, medial to the sternocleidomastoid muscle and lateral to the larynx. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular effects, clinical worsening or death (primary safety measure) | any of the following:
| 24 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treatment eligible patients (feasibility measure 1) | Proportion of eligible patients in whom nVNS can be started within the first 6 hours. | 6 hours |
| Proportion of patients completing all pre-specified treatment doses (feasibility measure 2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ethem M Arsava, MD | Hacettepe University | Principal Investigator |
| Mehmet A Topcuoglu, MD | Hacettepe University | Principal Investigator |
| Hakan Ay, MD | Massachusetts General Hospital, Harvard University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Faculty of Medicine | Ankara | Turkey (Türkiye) | ||||
| Gazi University Faculty Of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36356829 | Derived | Arsava EM, Topcuoglu MA, Ay I, Ozdemir AO, Gungor IL, Togay Isikay C, Nazliel B, Kozak HH, Ozturk S, Yilmaz IA, Dora B, Ay H; TR-VENUS investigators. Assessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute stroke. Brain Stimul. 2022 Nov-Dec;15(6):1467-1474. doi: 10.1016/j.brs.2022.10.012. Epub 2022 Nov 7. |
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| Gammacore sham device | Device | Sham device which does not deliver electrical stimulation, but instead, produces a buzzing sound will be placed along the lateral border of the sternocleidomastoid muscle in order to avoid mechanical stimulation of the vagus nerve in the carotid triangle. |
|
Proportion of enrolled patients who receive all the pre-specified treatment doses per protocol.
| 12 hours |
| Stroke onset to treatment time (feasibility measure 3) | Time from stroke onset to administration of the first dose of nVNS. | 6 hours |
| Early neurological outcome (efficacy measure 1) | Proportion of patients with NIHSS score≤4 or improvement of baseline NIHSS score ≥8 at 24 hours | 24 hours |
| Early tissue outcome (efficacy measure 2) | Delta infarct volume between baseline DWI and 24 hr MRI. | 24 hours |
| Local reaction at application site (secondary safety measure 1) | Local irritation or skin reaction during treatment application | 12 hours |
| Acute coronary syndrome (secondary safety measure 2) | Acute coronary syndrome | 24 hours |
| Symptomatic intracerebral hemorrhage (secondary safety measure 3) | Symptomatic intracerebral hemorrhage: ≥ 4 points increase in NIH Stroke Scale Score (NIHSS) together with a PH2 (parenchymal hematoma-2) type intracerebral hemorrhage | 24 hours |
| Death, clinical worsening, and acute coronary syndrome (secondary safety measure 4) | Combined outcome of death, clinical worsening, and acute coronary syndrome | 24 hours |
| New ischemic lesion or increase in hemorrhage (secondary safety measure 5) | New, spatially distinct remote ischemic lesion outside the arterial territory of the index lesion on MRI at 24 hours or greater than 30% increase in hemorrhage volume from baseline CT to 24 hour MRI in the subset with intracerebral hemorrhage | 24 hours |
| Serious adverse device event (SADE) rate (secondary safety measure 6) | Serious adverse device event (SADE) rate at 24 hours | 24 hours |
| Ankara |
| Turkey (Türkiye) |
| Hacettepe University Faculty of Medicine | Ankara | Turkey (Türkiye) |
| Akdeniz University | Antalya | Turkey (Türkiye) |
| Eskişehir Osmangazi Faculty of Medicine | Eskişehir | Turkey (Türkiye) |
| Necmettin Erbakan University | Konya | Turkey (Türkiye) |
| Selcuk University | Konya | Turkey (Türkiye) |
| Ondokuz Mayıs University Faculty of Medicine | Samsun | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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