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

I

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

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

Trial contacts and locations

1

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Central trial contact

Selim Sezikli, MD

Data sourced from clinicaltrials.gov

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