Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
NCT ID: NCT05456451
Last Updated: 2022-07-13
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
5 participants
INTERVENTIONAL
2022-07-25
2022-10-25
Brief Summary
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In this study, it was aimed to investigate the effects of non-invasive vagus nerve stimulation to be applied to patients with Parkinson's disease on tremor and vagus nerve activity in patients.
The tremor and autonomic activations of the participants will be evaluated at pre and post treatment.
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Detailed Description
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5 patients who meet the inclusion criteria will be included in this prospectively planned study. As a vagus stimulation protocol, noninvasive auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes will be applied to each patient 3 times on different days. Stimulations will be performed 3 times on 3 different days as the right ear, left ear and bilateral ear.
The tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically.
The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability with Polar device.
The participants will be evaluated pre and post-treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Parkinson group(pre and post treatment)
5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment
noninvasive vagus nerve srimulation
Non-invasive Vagus nerve stimulation (VNS) stimulates the vagus nerve through the ear via a headset. VNS is a non-pharmacological intervention with the potential to improve walking, cognition, fatigue, and autonomic functions in the treatment of Parkinson's disease.
Interventions
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noninvasive vagus nerve srimulation
Non-invasive Vagus nerve stimulation (VNS) stimulates the vagus nerve through the ear via a headset. VNS is a non-pharmacological intervention with the potential to improve walking, cognition, fatigue, and autonomic functions in the treatment of Parkinson's disease.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Parkinson's Disease by a specialist neurologist.
* Hoehn-Yahr stage 2-3.
* Having bilateral resting tremor of the hands.
* Being agreed to participate in the study.
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 breast-feed during the study period.
* Botox injections or any other upper extremity rehabilitation within 6 months prior to treatment.
40 Years
65 Years
ALL
No
Sponsors
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Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Acibadem Atakent University Hospital
OTHER
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
OTHER_GOV
Kanuni Sultan Suleyman Training and Research Hospital
OTHER
Responsible Party
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Merve Damla Korkmaz
Medical Doctor
Principal Investigators
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E. Efe Is, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sisli Hamidiye Etfal Training and Research Hospital
Ceyhun Basoglu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Acibadem Atakent University Hospital
Mustafa Corum, M.D.
Role: PRINCIPAL_INVESTIGATOR
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Ali Veysel Ozden, M.D.
Role: PRINCIPAL_INVESTIGATOR
Bahçeşehir University
Locations
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Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 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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3616
Identifier Type: -
Identifier Source: org_study_id
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