Effects of Transcutaneous Cervical Vagus Nerve Stimulation on Non-motor Symptoms in Parkinson's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-79
SponsorKyoungwon Baik
About this trial
The goal of this clinical trial is to learn if home-based transcutaneous cervical vagus nerve stimulation (tcVNS) can improve symptoms in adults with Parkinson's disease. tcVNS uses a small portable device placed on the skin of the left side of the neck to deliver mild electrical stimulation. It does not require surgery or anesthesia.
The main questions it aims to answer are:
* Does tcVNS reduce non-motor symptoms of Parkinson's disease, such as sleep problems, low mood, anxiety, digestive problems, and fatigue? * Does tcVNS change movement symptoms, memory and thinking, brain wave activity, heart rhythm patterns, and markers of inflammation in the blood? * Can participants use the device safely on their own at home every day, and what medical problems do they have while using it?
Everyone in this study will use the same stimulation device. There is no placebo group. Researchers will compare each participant's own measurements taken before stimulation, after 4 weeks of stimulation, and again after a 4-week break, to see whether symptoms change and whether any change lasts.
Participants will:
* Use the stimulation device on the neck for 30 minutes once a day, at home, every day for 4 weeks. The first session is done at the clinic with study staff, who teach participants how to use the device. * Visit the clinic 6 times over about 9 weeks for physical and neurological checkups, questionnaires about their symptoms, memory and thinking tests, brain wave recordings (EEG), and heart rhythm recordings (HRV). * Give a blood sample of about 10 mL at 3 of the visits (about 30 mL in total) so researchers can measure markers of inflammation. * Have a brain MRI scan at 2 of the visits, at centers where MRI is available. * Keep a record of their device use in a paper diary or a smartphone app. The device also records use times automatically.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Idiopathic Parkinson's disease diagnosed according to the UK Brain Bank criteria and the MDS Clinical Diagnostic Criteria for Parkinson's Disease
Hoehn and Yahr stage I to III, assessed in the ON state
Aged 20 to 79 years
If taking antiparkinsonian medication (e.g., levodopa, dopamine agonists), on a stable regimen for at least 4 weeks before enrollment
Disqualifiers
Secondary parkinsonism (e.g., vascular, drug-induced, multiple system atrophy) or an atypical parkinsonian syndrome
Presence of a deep brain stimulation (DBS) device, or planned DBS surgery during the study period
Active cardiac arrhythmia, or presence of an implanted cardiac pacemaker or an implantable cardioverter-defibrillator (ICD), which are contraindications to vagus nerve stimulation
History of open surgery of the neck, or history of cervical nerve injury
Trial design
Design model
Single group
Treatments tested in this trial
transcutaneous vagus nerve stimulation
DeviceUse the transcutaneous vagus nerve stimulation device on the neck for 30 minutes once a day, at home, every day for 4 weeks.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in MDS-NMS total score
The Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) assesses the severity and frequency of non-motor symptoms in Parkinson's disease across multiple domains. Total score range \[0-832\]; higher scores indicate greater non-motor symptom burden.
Time frame
Baseline and Week 5 (immediately after the 4-week stimulation period)Secondary outcomes
1
Change in MDS-UPDRS Part I score
MDS-UPDRS Part I assesses non-motor aspects of experiences of daily living. 13 items scored 0-4; total range 0-52. Higher scores indicate greater impairment.
Time frame
Baseline, Week 5, and Week 92
Change in MDS-UPDRS Part II score
MDS-UPDRS Part II assesses motor aspects of experiences of daily living. 13 items scored 0-4; total range 0-52. Higher scores indicate greater impairment.
Time frame
Baseline, Week 5, and Week 93
Change in MDS-UPDRS Part III score
MDS-UPDRS Part III is the motor examination. 33 scored items rated 0-4; total range 0-132. Higher scores indicate greater motor impairment.
Time frame
Baseline, Week 5, and Week 94
Change in Mini-Mental State Examination (MMSE) score
The MMSE is a screening measure of global cognitive function. Total range 0-30; higher scores indicate better cognition.
Time frame
Baseline, Week 5, and Week 9Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kyoungwon Baik
Lead sponsor
Korea University Anam Hospital
Sponsor institution
Chung-Ang University Gwangmyeong Hospital
Collaborator
Source ClinicalTrials.gov
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