Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease

Study Overview
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Brief Summary
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Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release. 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.

Detailed Description
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Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release. 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.

Official Title
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Investigation of the Effectiveness of Noninvasive Vagus Stimulation on Upper Extremity Functions in Parkinson's Disease

Conditions
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Parkinson Disease, Upper Extremity Dysfunction, Tremor

Intervention / Treatment
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* Device: noninvasive vagus nerve srimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being between the ages of 40-65. 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: 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 breast-feed during the study period. Botox injections or any other upper extremity rehabilitation within 6 months prior to treatment.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The participants wit Parkinson disease, who has Hohen Yahr grade 2-3 will be included in the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson group(pre and post treatment)<br>5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment | Device: noninvasive vagus nerve srimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tremor | 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. This application provides the opportunity to evaluate tremor numerically in patients with tremor, and there are studies where it has been used before in Parkinson's disease. | 1 day | 
| autonomic nervous system | The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability by using Polar device. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vagus nerve stimulation, tremor, parkinson disease, upper extremity