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

NCT05809037 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-04-12

No results posted yet for this study

Summary

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.

Conditions

  • Stroke, Ischemic
  • Hemiplegia
  • Hemiparesis;Poststroke/CVA

Interventions

DEVICE

transcutaneous auricular vagus nerve stimulation

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, pulse width is 300 µs, and biphasic.

DEVICE

Sham stimulation

In addition to the conventional rehabilitation program, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. 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, and noninvasive auricular stimulation will be applied.

Sponsors & Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Selim Sezikli, MD · Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2023-12-27
Completion
2024-03-27

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05809037 on ClinicalTrials.gov