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

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Status: Enrolling

Conditions: Hemiparesis;Poststroke/CVA; Hemiplegia; Stroke, Ischemic

Treatments: Device: transcutaneous auricular vagus nerve stimulation; Device: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05809037

2022/382

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Active Stimulation for right hemiparesis patients

Active Comparator group

Description:

Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis

Treatment:

Device: transcutaneous auricular vagus nerve stimulation

Sham Stimulation for right hemiparesis patients

Sham Comparator group

Description:

Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis

Treatment:

Device: Sham stimulation

Active Stimulation for left hemiparesis patients

Active Comparator group

Description:

Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis

Treatment:

Device: transcutaneous auricular vagus nerve stimulation

Sham Stimulation for left hemiparesis patients

Sham Comparator group

Description:

Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis

Treatment:

Device: Sham stimulation