Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
Primary Purpose
Parkinson Disease, Upper Extremity Dysfunction, Tremor
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
noninvasive vagus nerve srimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring vagus nerve stimulation, tremor, parkinson disease, upper extremity
Eligibility Criteria
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.
Sites / Locations
- Kanuni Sultan Suleyman Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parkinson group(pre and post treatment)
Arm Description
5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment
Outcomes
Primary Outcome Measures
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.
autonomic nervous system
The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability by using Polar device.
Secondary Outcome Measures
Full Information
NCT ID
NCT05456451
First Posted
July 11, 2022
Last Updated
July 11, 2022
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Collaborators
Sisli Hamidiye Etfal Training and Research Hospital, Acibadem Atakent University Hospital, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05456451
Brief Title
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
Official Title
Investigation of the Effectiveness of Noninvasive Vagus Stimulation on Upper Extremity Functions in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 25, 2022 (Anticipated)
Primary Completion Date
September 25, 2022 (Anticipated)
Study Completion Date
October 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Collaborators
Sisli Hamidiye Etfal Training and Research Hospital, Acibadem Atakent University Hospital, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Upper Extremity Dysfunction, Tremor
Keywords
vagus nerve stimulation, tremor, parkinson disease, upper extremity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The participants wit Parkinson disease, who has Hohen Yahr grade 2-3 will be included in the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parkinson group(pre and post treatment)
Arm Type
Experimental
Arm Description
5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment
Intervention Type
Device
Intervention Name(s)
noninvasive vagus nerve srimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
tremor
Description
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.
Time Frame
1 day
Title
autonomic nervous system
Description
The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability by using Polar device.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Damla Korkmaz, M.D.
Phone
+90(212) 404 15 00
Email
mervedml@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
A. Kivanc Menekseoglu, M.D.
Phone
+90(212) 404 15 00
Email
kivancmenekseoglu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Efe Is, M.D.
Organizational Affiliation
Sisli Hamidiye Etfal Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ceyhun Basoglu, M.D.
Organizational Affiliation
Acibadem Atakent University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mustafa Corum, M.D.
Organizational Affiliation
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Veysel Ozden, M.D.
Organizational Affiliation
Bahçeşehir University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Kucukcekmece
ZIP/Postal Code
34303
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merve Damla Korkmaz, M.D.
Phone
+90(212) 404 15 00
Email
mervedml@gmail.com
First Name & Middle Initial & Last Name & Degree
A. Kivanc Menekseoglu, M.D.
Email
kivancmenekseoglu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
not decided
Learn more about this trial
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
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