Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke
Stroke, Ischemic, Hemiplegia, Hemiparesis;Poststroke/CVA
About this trial
This is an interventional treatment trial for Stroke, Ischemic
Eligibility Criteria
Inclusion Criteria: History of subacute-chronic ischemic stroke (3-12 months) Exclusion Criteria: Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy). Severe depression (Beck Depression Scale > 29) Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline. Pregnancy or planning to become pregnant or breastfeed during the study period. Botox injections or hemiplegia rehabilitation within 6 months before treatment. Having a history of hemorrhagic stroke Presence of ongoing dysphagia or aspiration difficulties.
Sites / Locations
- Istanbul Physical Medicine and Rehabilitation Training and research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Sham Comparator
Active Comparator
Sham Comparator
Active Stimulation for right hemiparesis patients
Sham Stimulation for right hemiparesis patients
Active Stimulation for left hemiparesis patients
Sham Stimulation for left hemiparesis patients
Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis
Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis
Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis
Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis