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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease; Upper Extremity Dysfunction; Tremor
• Intervention / Treatment: Device: noninvasive vagus nerve srimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merve Damla Korkmaz, M.D.; Phone Number: +90(212) 404 15 00; Email: mervedml@gmail.com
• Study Contact Backup: Name: A. Kivanc Menekseoglu, M.D.; Phone Number: +90(212) 404 15 00; Email: kivancmenekseoglu@gmail.com

Study Locations

• Turkey
  • Kucukcekmece
    • Istanbul, Kucukcekmece, Turkey, 34303
      • Kanuni Sultan Suleyman Training and Research Hospital
      • Contact: Merve Damla Korkmaz, M.D.; Phone Number: +90(212) 404 15 00; Email: mervedml@gmail.com
      • Contact: A. Kivanc Menekseoglu, M.D.; Email: kivancmenekseoglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson group(pre and post treatment); 5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Collaborators: Sisli Hamidiye Etfal Training and Research Hospital; Istanbul Physical Medicine Rehabilitation Training and Research Hospital; Acibadem Atakent University Hospital
• Investigators: Principal Investigator: E. Efe Is, M.D., Sisli Hamidiye Etfal Training and Research Hospital; Principal Investigator: Ceyhun Basoglu, M.D., Acibadem Atakent University Hospital; Principal Investigator: Mustafa Corum, M.D., Istanbul Physical Medicine and Rehabilitation Training and Research Hospital; Principal Investigator: Ali Veysel Ozden, M.D., Bahçeşehir University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 25, 2022
• Primary Completion (Anticipated): September 25, 2022
• Study Completion (Anticipated): October 25, 2022

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: vagus nerve stimulation; upper extremity; tremor; parkinson disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Tremor
• Other Study ID Numbers: 3616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: not decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No