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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05456451
• Other study ID #: 3616
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: October 25, 2022

Study information

• Verified date: July 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Merve Damla Korkmaz, M.D.
• Phone: +90(212) 404 15 00
• Email: mervedml[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: October 25, 2022
• Est. primary completion date: September 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Tremor
• Upper Extremity Dysfunction

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Kucukcekmece

Sponsors (4)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital	Acibadem Atakent University Hospital, Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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