Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-03 @ 1:56 AM
Study NCT ID:
NCT05456451
Status:
UNKNOWN
Last Update Posted:
2022-07-13
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
Sponsor:
Kanuni Sultan Suleyman Training and Research Hospital
Organization:
Study Overview
Official Title:
Investigation of the Effectiveness of Noninvasive Vagus Stimulation on Upper Extremity Functions in Parkinson's Disease
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: