Effects of Transcutaneous Cervical Vagus Nerve Stimulation on Non-motor Symptoms in Parkinson's Disease

N/ANot Yet RecruitingNCT07839481

Kyoungwon Baik15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Willing to participate voluntarily and able to provide written informed consent * Able to attend the scheduled study visits and to perform the home-based intervention throughout the study period Exclusion Criteria: * 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 * Active epilepsy, or a seizure within the past year * Dementia, or inability to provide independent informed consent * Active psychiatric illness, including schizophrenia, acute-phase bipolar disorder, or severe depression with suicidal risk * Intracranial lesions such as stroke, brain tumor, or hydrocephalus * Contraindications to MRI, such as cerebral aneurysm clips, cochlear implants, or other ferromagnetic foreign bodies; metallic joint prostheses are assessed on a case-by-case basis * Pregnant or breastfeeding women, and women of childbearing potential who plan to become pregnant during the study or who are not using adequate contraception * Participation in another clinical trial within the past 3 months * History of alcohol or substance abuse within the past 6 months * Any other condition that, in the judgment of the investigator, makes the participant unsuitable for study participation

Outcomes

Primary Outcomes

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

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.