NCT07839481Not yet recruiting
Effects of Transcutaneous Cervical Vagus Nerve Stimulation on Non-motor Symptoms in Parkinson's Disease
Effects of Home-Based Transcutaneous Cervical Vagus Nerve Stimulation (tcVNS) on Clinical Symptoms and Neurophysiological Biomarkers in Patients With Parkinson's Disease: A Proof-of-Concept Clinical Trial
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Kyoungwon Baik
- Diseases
- Parkinson disease
- NCT number
- NCT07839481
What you commit to
- Study type: Interventional
- Planned participants: 15
- From Sept 2026 to the primary completion date, Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of a deep brain stimulation (DBS) device, or planned DBS surgery during the study period
- 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
Other illness
- Secondary parkinsonism (e.g., vascular, drug-induced, multiple system atrophy) or an atypical parkinsonian syndrome
- 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
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 79 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.