non-invasive transcutaneous cervical vagus nerve stimulation as a treatment for acute stroke; safety and feasibility study

Conditions: Stroke, Acute; Stroke, Ischemic; Stroke; Stroke, Hemorrhagic

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.


Eligibility criteria:
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.

Keywords: vagal nerve stimulation