Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke
NCT ID: NCT05809037
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2023-03-27
2024-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Stimulation for right hemiparesis patients
Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis
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.
Sham Stimulation for right hemiparesis patients
Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis
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.
Active Stimulation for left hemiparesis patients
Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis
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.
Sham Stimulation for left hemiparesis patients
Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Istanbul Physical Medicine Rehabilitation Training and Research Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Selim Sezikli, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Locations
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Istanbul Physical Medicine and Rehabilitation Training and research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022/382
Identifier Type: -
Identifier Source: org_study_id
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