Parkinson's Disease (PD)tcVNS-PDNCT07839481
Effects of Transcutaneous Cervical Vagus Nerve Stimulation on Non-motor Symptoms in Parkinson's Disease
A study testing transcutaneous vagus nerve stimulation in people with Parkinson's Disease (PD) and Parkinson Disease (PD), run by Kyoungwon Baik.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Parkinson's Disease (PD), Parkinson Disease (PD)
- What is being tested?
- transcutaneous vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official 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
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:
Read more
- 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.
- Conditions
- Parkinson's Disease (PD), Parkinson Disease (PD)
- Being tested
- transcutaneous vagus nerve stimulation
- Keywords
- vagus nerve stimulation, neuromodulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagus nerve stimulationDevice
Use the transcutaneous vagus nerve stimulation device on the neck for 30 minutes once a day, at home, every day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Device: transcutaneous vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 5 (immediately after the 4-week stimulation period)
Secondary outcomes (13)
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.
Measured: Baseline, Week 5, and Week 9
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.
Measured: Baseline, Week 5, and Week 9
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.
Measured: Baseline, Week 5, and Week 9
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.
Measured: Baseline, Week 5, and Week 9
Change in Montreal Cognitive Assessment (MoCA) score
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.
Measured: Baseline, Week 5, and Week 9
Change in Pittsburgh Sleep Quality Index (PSQI) global score
The PSQI assesses subjective sleep quality over the preceding month. Global score range 0-21; higher scores indicate poorer sleep quality.
Measured: Baseline, Week 5, and Week 9
Change in REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) score
The RBDSQ screens for REM sleep behavior disorder. Total range 0-13; higher scores indicate a greater likelihood of REM sleep behavior disorder.
Measured: Baseline, Week 5, and Week 9
Change in Epworth Sleepiness Scale (ESS) score
The ESS assesses daytime sleepiness across eight everyday situations. Total range 0-24; higher scores indicate greater daytime sleepiness.
Measured: Baseline, Week 5, and Week 9
Change in Geriatric Depression Scale (GDS) score
The GDS short form screens for depressive symptoms in older adults. Total range 0-15; higher scores indicate more depressive symptoms.
Measured: Baseline, Week 5, and Week 9
Change in State-Trait Anxiety Inventory (STAI) State subscale score
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.
Measured: Baseline, Week 5, and Week 9
Change in GIDS-PD score
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.
Measured: Baseline, Week 5, and Week 9
Number of participants with adverse events and serious adverse events
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.
Measured: From informed consent through Week 9
Adherence to home-based stimulation
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.
Measured: Over the 4-week stimulation period (Week 1 to Week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoungwon Baik
- Sponsor type
- University, hospital or other
- Collaborators
- Chung-Ang University Gwangmyeong Hospital
- Responsible party
- Sponsor-investigator, Kyoungwon Baik, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839481
- Sponsor's protocol ID
- 2026AN0465
- Acronym
- tcVNS-PD
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07839481
- Acronym / sponsor ID
- tcVNS-PD / 2026AN0465
- Conditions
- Parkinson's Disease (PD), Parkinson Disease (PD)
- Keywords
- vagus nerve stimulation, neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kyoungwon BaikUniversity, hospital or other
- Collaborators
- Chung-Ang University Gwangmyeong Hospital
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: transcutaneous vagus nerve stimulation |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous vagus nerve stimulationUse the transcutaneous vagus nerve stimulation device on the neck for 30 minutes once a day, at home, every day for 4 weeks. | Device | Treatment arm |
Primary outcome
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.
13 secondary outcomes
Change in MDS-UPDRS Part I score
Time frame: Baseline, Week 5, and Week 9
Change in MDS-UPDRS Part II score
Time frame: Baseline, Week 5, and Week 9
Change in MDS-UPDRS Part III score
Time frame: Baseline, Week 5, and Week 9
Change in Mini-Mental State Examination (MMSE) score
Time frame: Baseline, Week 5, and Week 9
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: Baseline, Week 5, and Week 9
Change in Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: Baseline, Week 5, and Week 9
Change in REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) score
Time frame: Baseline, Week 5, and Week 9
Change in Epworth Sleepiness Scale (ESS) score
Time frame: Baseline, Week 5, and Week 9
Change in Geriatric Depression Scale (GDS) score
Time frame: Baseline, Week 5, and Week 9
Change in State-Trait Anxiety Inventory (STAI) State subscale score
Time frame: Baseline, Week 5, and Week 9
Change in GIDS-PD score
Time frame: Baseline, Week 5, and Week 9
Number of participants with adverse events and serious adverse events
Time frame: From informed consent through Week 9
Adherence to home-based stimulation
Time frame: Over the 4-week stimulation period (Week 1 to Week 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagus nerve stimulation in people with Parkinson's Disease (PD) and Parkinson Disease (PD), run by Kyoungwon Baik.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MDS-NMS total score (time frame: Baseline and Week 5 (immediately after the 4-week stimulation period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.