NCT03733431CompletedNot Applicable
Non-invasive TRanscutaneous Cervical Vagus Nerve Stimulation as a Treatment for Acute Stroke; Safety and Feasibility Study
Turkish Stroke Research and Clinical Trials Network8 sites in 1 country69 target enrollmentStarted: May 10, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 8
- Primary Endpoint
- Cardiovascular effects, clinical worsening or death (primary safety measure)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients who are older than 18 years old who have been admitted to neurological intensive care or stroke units with ischemic or hemorrhagic stroke
- •Patients with symptom onset time within 6 hours or with unknown time of onset and no evidence of acute ischemia on fluid attenuation inversion recovery (FLAIR) imaging
- •Patients who have given written informed consent prior to undertaking any study-related procedure.
Exclusion Criteria
- •Patients who have a pre-stroke disability ≥ 2 according to the modified Rankin Score
- •Patients who have a NIH Stroke Scale/Score (NIHSS) ≤ 4 or ≥30
- •Patients who have a NIHSS item 1a ≥2
- •Patients who have experienced early dramatic neurological improvement (NIHSS score improvement ≥8) prior to study randomization suggesting resolution of signs/symptoms of stroke
- •Patients with classical lacunar syndrome
- •Patients who have local infection, rash or space occupying lesion at the stimulation site
- •Patients with a prior injury to the vagus nerve (cervical vagotomy)
- •Patients with conditions that make the positioning of the device not possible such as tonic head deviation or involuntary movements of the head and neck
- •Patients using medications that can interfere with central neurotransmitter mechanisms potentially involved in the central vagal pathway (complete list is provided below under concomitant medications)
- •Patients with known severe (>90% stenosis) bilateral carotid artery disease
- •Patients with known carotid hypersensitivity
- •Patients who had undergone bilateral carotid endarterectomy or neck surgery involving the region of carotid triangle
- •Patients who have low blood pressure (Baseline SBP≤100 mmHg or DBP≤60 mmHg)
- •Patients who have slow heart rate (Baseline HR≤60/min)
- •Patients who have high blood pressure (SBP>220 mmHg or DBP>130 mmHg) despite initial line of treatment
- •Patients who have been involved in any investigational study within the previous 90 days
- •Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
- •Pregnant women
- •Patients with severe hypoglycemia at admission (<60 mg/dl)
- •Patient experiencing seizures
- •Patients with baseline ECG showing first-degree AV block; second- or third-degree atrio-ventricular block with no pacemaker/ICD in place; or ventricular tachycardia/fibrillation
- •Patients with digitalis toxicity
- •Patients who are suspected to have an acute coronary syndrome after clinical evaluations (Clinical, ECG, or any related biomarker)
- •Patients who are scheduled to have an emergent carotid artery angioplasty stenting or endarterectomy
- •Patients implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
- •Patients implanted with metal cervical spine hardware or having a metallic implant near the GammaCore stimulation site.
Outcomes
Primary Outcomes
Cardiovascular effects, clinical worsening or death (primary safety measure)
Time Frame: 24 hours
any of the following: * severe bradycardia (HR ≤50/min) during treatment application * significant decrease in arterial blood pressure (≥20 mmHg decrease in mean arterial blood pressure) during treatment application * neurological worsening (progression of neurologic deficit as shown by ≥ 4 points increase in NIH Stroke Scale Score) within 24 hours * death within 24 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Ethem Murat Arsava
Professor of Neurology
Hacettepe University
Study Sites (8)
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