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NCT Number: NCT07839481

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

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.

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinson Disease (PD) Parkinsonian Disorders Synucleinopathies

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous vagus nerve stimulation

Device

Use the transcutaneous vagus nerve stimulation device on the neck for 30 minutes once a day, at home, every day for 4 weeks.

Primary outcomes

  1. Change in MDS-NMS total score

    Time frame: Baseline and Week 5 (immediately after the 4-week stimulation period)

    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.

Secondary outcomes

  1. Change in MDS-UPDRS Part I score

    Time frame: Baseline, Week 5, and Week 9

    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.

  2. Change in MDS-UPDRS Part II score

    Time frame: Baseline, Week 5, and Week 9

    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.

  3. Change in MDS-UPDRS Part III score

    Time frame: Baseline, Week 5, and Week 9

    MDS-UPDRS Part III is the motor examination. 33 scored items rated 0-4; total range 0-132. Higher scores indicate greater motor impairment.

  4. Change in Mini-Mental State Examination (MMSE) score

    Time frame: Baseline, Week 5, and Week 9

    The MMSE is a screening measure of global cognitive function. Total range 0-30; higher scores indicate better cognition.

  5. Change in Montreal Cognitive Assessment (MoCA) score

    Time frame: Baseline, Week 5, and Week 9

    The MoCA is a screening measure of global cognitive function with greater sensitivity to mild impairment. Total range 0-30; higher scores indicate better cognition.

  6. Change in Pittsburgh Sleep Quality Index (PSQI) global score

    Time frame: Baseline, Week 5, and Week 9

    The PSQI assesses subjective sleep quality over the preceding month. Global score range 0-21; higher scores indicate poorer sleep quality.

  7. Change in REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) score

    Time frame: Baseline, Week 5, and Week 9

    The RBDSQ screens for REM sleep behavior disorder. Total range 0-13; higher scores indicate a greater likelihood of REM sleep behavior disorder.

  8. Change in Epworth Sleepiness Scale (ESS) score

    Time frame: Baseline, Week 5, and Week 9

    The ESS assesses daytime sleepiness across eight everyday situations. Total range 0-24; higher scores indicate greater daytime sleepiness.

  9. Change in Geriatric Depression Scale (GDS) score

    Time frame: Baseline, Week 5, and Week 9

    The GDS short form screens for depressive symptoms in older adults. Total range 0-15; higher scores indicate more depressive symptoms.

  10. Change in State-Trait Anxiety Inventory (STAI) State subscale score

    Time frame: Baseline, Week 5, and Week 9

    The STAI Form Y-1 measures state anxiety. 20 items; total range 20-80. Higher scores indicate greater anxiety. The STAI Form Y-2 measures trait anxiety. 20 items; total range 20-80. Higher scores indicate greater anxiety.

  11. Change in GIDS-PD score

    Time frame: Baseline, Week 5, and Week 9

    The Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) assesses the severity and impact of gastrointestinal symptoms. Total score range [1-108]; higher scores indicate greater gastrointestinal dysfunction.

  12. Number of participants with adverse events and serious adverse events

    Time frame: From informed consent through Week 9

    Adverse events and serious adverse events are recorded from the time of informed consent through the final study visit and graded using NCI-CTCAE. Events of particular interest include application-site skin reactions, headache, dizziness, nausea, fatigue, palpitations, and changes in blood pressure or heart rate.

  13. Adherence to home-based stimulation

    Time frame: Over the 4-week stimulation period (Week 1 to Week 5)

    Adherence is calculated as the number of days the device was actually used divided by the 28 planned days, multiplied by 100, derived from the device's internal timestamp log and the participant diary or smartphone application.

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Sponsors and collaborators

Lead sponsor

Kyoungwon Baik

Other

Collaborators

  • Chung-Ang University Gwangmyeong Hospital

Registry information

Official study title

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

Acronym: tcVNS-PD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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