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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05456451
Other study ID # 3616
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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