Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke

Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke

In this study, the effectiveness of vagus nerve stimulation in patients with right and left hemiparesis will be compared with each other and with the sham application.

This prospective study will include 80 participants with a diagnosis of ischemic stroke who meet the inclusion criteria. In addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, the pulse width is 300 µs, biphasic. In the study, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. The study will be completed when the evaluation of the participants is made in the 1st and 3rd months after the last intervention. The upper extremity functions of the patients participating in the study were determined by Fugl-Meyer upper extremity test and box and block test, upper and lower extremity spasticities by modified Ashworth scale, and sleep quality by Pittsburgh sleep quality index. Quality of life will be evaluated with the stroke-specific quality of life scale, balance functions with the Berg balance test, dependency levels in daily activities with the Barthel index, and sympathetic dysfunctions with COMPASS-31. Participants' blood pressure and pulse values will be evaluated before and after each session.

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.