Idiopathic Parkinson DiseaseVNSNCT07908498
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
A study testing cVNS, eVNS and sVNS in people with Idiopathic Parkinson Disease, run by Chinese University of Hong Kong.
Trial summary
Although breakthroughs in the management of Parkinson's disease (PD) have emerged in recent decades resulting in better control in symptoms, majority of patients with PD are still living with various disabling motor and non-motor symptoms despite they are already receiving the best contemporary medical or surgical… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- cVNS, eVNS and sVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2026to 30 Jun 2028
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD as defined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
- Age 40 - 75 years old
- Presence of gait impairment as defined by any one of the below:
- a UPDRS Part 2 Item 15 (Walking) with a score of 2 b. UPDRS Part 3 Item 26 (leg Agility) with score of 2 or 3 c. UPDRS Part 3 Item 29 (Gait) with score of 1 or 2
- Availability of a caregiver at home
- Cantonese speaker
Who cannot join
- Patients with atypical parkinsonism (e.g., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy Bodies)
- PD with dementia
- PD patients with DBS in-situ
- Severe PD with a Hoehn and Yahr staging of 4 or above
- Low blood pressure with systolic of < 110 mmHg or with postural hypotension as defined by a decrease in systolic and diastolic blood pressure by 20 mmHg and 10mmHg upon standing, respectively)
- Cardiac pacemaker in-situ
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Although breakthroughs in the management of Parkinson's disease (PD) have emerged in recent decades resulting in better control in symptoms, majority of patients with PD are still living with various disabling motor and non-motor symptoms despite they are already receiving the best contemporary medical or surgical treatments available to them. There is obviously a need to develop additional treatment modality to further optimize the control of symptoms and/or slow the disease progression for patients having PD.
Vagus nerve stimulation (VNS), a type of noninvasive brain stimulation is believed to modify brain rhythms by modulating the nucleus of the solitary tract and locus coeruleus and other regions known to play a role in gait. Moreover, VNS may modulate inflammatory pathways and reduce oxidative stress, making it a potential disease modifying treatment approach for neurodegenerative diseases linked to neuroinflammation such as PD
Further study is warranted to explore the efficacy of non-invasive VNS for its effects on gait and other symptoms of PD as well as the anti-inflammatory effects.
Read the detailed description
The objective of the present study is to investigate the feasibility, safety, and potential efficacy of 2 different non-invasive VNS stimulation protocols (conventional and exploratory) for patients with PD. The immediate effects of VNS as well as the medium-term effects of daily VNS at 2 and 4 weeks poststimulation, and the delayed effects of non-invasive VNS at 8 weeks of both stimulation protocols will be investigated. The effects of non-invasive VNS of the 2 different stimulation protocols will also be compared with sham stimulation. The study will be a randomized single blind study. The tested subjects, not the assessor, will be kept unaware of which treatment protocols they are receiving.
The investigator hypothesize the VNS stimulations may provide immediate effects, medium term effects and delayed effects.
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- cVNS, eVNS, sVNS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cVNSDevice
The cVNS emits a low-voltage 5.56 KHz sinusoidal wave electrical signal bursts lasting 0.9 ms via two flat stimulation contact surfaces. (Figure 2) These bursts repeat once every 38 millisecond (ms). Each set of stimulation will be applied for 2 minutes. Stimulation current can be self-adjusted by the subject. This conventional stimulation waveform was approved by the US FDA for the treatment of migraines.
eVNSDevice
The eVNS emits the company-proprietary low-voltage of 3~8 KHz sine-variant smooth-transition wave electrical signal bursts lasting near 0.9 ms via two flat stimulation contact surfaces. These bursts repeat once in intervals of approximately 40 ms. A potential benefit of this waveform is that it can produce less unpleasant skin sensations at a given current intensity and this may enhance the subject to tolerate higher current intensity than that of the conventional stimulation.
sVNSDevice
The sVNS delivers mechanical motor vibrations to provide a similar perceptible stimulation feeling to the skin. No electrical stimulations are delivered. The device that delivers the sham stimulation is identical in appearance, weight, and user interface. A button to adjust "stimulation current" is also available in the sham device so as to allow the subject/caregiver to adjust the "stimulation current"
| Study group | Role | What they receive |
|---|---|---|
| conventional VNS | Active comparator | Parkinson Disease Receives: Device: cVNS |
| exploratory VNS | Active comparator | Not described Receives: Device: eVNS |
| sham VNS | Sham comparator | Not described Receives: Device: sVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gait
Timed UP and Go test: Participant sits back in a standard armchair with their back against the chair and hands resting on the armrests. Regular footwear and usual walking aids (like a cane or walker) are used. On the word "Go", the person stands up, walks a distance of 3 meters (10 feet) to a marked line or cone at a normal, safe pace, turns around, walks back to the chair, and sits down again. A stopwatch starts the moment the word "Go" is spoken and stops the moment the person's buttocks touch the seat. The results in second will be interpret to assist mobility and risk of falling. The longer the time, the high risk of fall
Measured: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Severity and progression of Parkinson's disease
Using Unified Parkinson's Disease Rating Scale to motor and non-motor symptoms. Score from 0 to 4. 0 is normal while 4 is severe/marked impairment
Measured: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Quantitative Gait Assessment
Using an app to track the mobility of participants in a 20 sec walking
Measured: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Cognitive status
Using Hong Kong Montreal Cognitive Assessment to evaluate the cognitive status. score from 0-30. The lower the score, the more cognitive impaired.
Measured: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Change in mood
Using Geriatric depression scale which contain 15 questions. Score from 0-15. The higher the score, the more severe the depressed mood
Measured: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Secondary outcomes (3)
Change of blood pressure
Measured: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Safety measures- record of adverse event and serious adverse event
To investigate any possibility and relativity of AE and SAE with the treatment
Measured: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Electrocardiogram
To investigate any possibility and relativity of the change of ECG with the treatment
Measured: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 subjects subject with PD will be recruited and divided into 3 groups. The sample size of 20 per group is based on a previous pilot study showing the potential positive efficacy of VNS with a sample size of 17-19 subjects per treatment arm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Mok, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908498
- Sponsor's protocol ID
- 2025.519
- Acronym
- VNS
- Status last verified
- Nov 2026
- First submitted
- 22 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication will be shared
Publications
Castro JI, Valencia Llano CH, Tenorio DL, Saavedra M, Zapata P, Navia-Porras DP, Delgado-Ospina J, Chaur MN, Hernandez JHM, Grande-Tovar CD. Biocompatibility Assessment of Polylactic Acid (PLA) and Nanobioglass (n-BG) Nanocomposites for Biomedical Applications. Molecules. 2022 Jun 6;27(11):3640. doi: 10.3390/molecules27113640.
PubMed 35684575Eissazade N, Eghdami S, Rohani M, Ajdari A, Fereshtehnejad SM, Fasano A, Khoeini T. Noninvasive Vagus Nerve Stimulation in Parkinson's Disease: A Systematic Review. Neuromodulation. 2025 Jun;28(4):641-651. doi: 10.1016/j.neurom.2025.01.012. Epub 2025 Mar 6.
PubMed 40057881Mondal B, Choudhury S, Banerjee R, Roy A, Chatterjee K, Basu P, Singh R, Halder S, Shubham S, Baker SN, Baker MR, Kumar H. Effects of non-invasive vagus nerve stimulation on clinical symptoms and molecular biomarkers in Parkinson's disease. Front Aging Neurosci. 2024 Feb 7;15:1331575. doi: 10.3389/fnagi.2023.1331575. eCollection 2023.
PubMed 38384731
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07908498
- Acronym / sponsor ID
- VNS / 2025.519
- Conditions
- Idiopathic Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Nov 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.
Although breakthroughs in the management of Parkinson's disease (PD) have emerged in recent decades resulting in better control in symptoms, majority of patients with PD are still living with various disabling motor and non-motor symptoms despite they are already receiving the best contemporary medical or surgical treatments available to them. There is obviously a need to develop additional treatment modality to further optimize the control of symptoms and/or slow the disease progression for patients having PD.
Vagus nerve stimulation (VNS), a type of noninvasive brain stimulation is believed to modify brain rhythms by modulating the nucleus of the solitary tract and locus coeruleus and other regions known to play a role in gait. Moreover, VNS may modulate inflammatory pathways and reduce oxidative stress, making it a potential disease modifying treatment approach for neurodegenerative diseases linked to neuroinflammation such as PD
Further study is warranted to explore the efficacy of non-invasive VNS for its effects on gait and other symptoms of PD as well as the anti-inflammatory effects.
Detailed description
The objective of the present study is to investigate the feasibility, safety, and potential efficacy of 2 different non-invasive VNS stimulation protocols (conventional and exploratory) for patients with PD. The immediate effects of VNS as well as the medium-term effects of daily VNS at 2 and 4 weeks poststimulation, and the delayed effects of non-invasive VNS at 8 weeks of both stimulation protocols will be investigated. The effects of non-invasive VNS of the 2 different stimulation protocols will also be compared with sham stimulation. The study will be a randomized single blind study. The tested subjects, not the assessor, will be kept unaware of which treatment protocols they are receiving.
The investigator hypothesize the VNS stimulations may provide immediate effects, medium term effects and delayed effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 60 subjects subject with PD will be recruited and divided into 3 groups. The sample size of 20 per group is based on a previous pilot study showing the potential positive efficacy of VNS with a sample size of 17-19 subjects per treatment arm
| Arm | Type | Receives |
|---|---|---|
| conventional VNS | Active comparator | Device: cVNSParkinson Disease |
| exploratory VNS | Active comparator | Device: eVNS |
| sham VNS | Sham comparator | Device: sVNS |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Idiopathic PD as defined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
- Age 40 - 75 years old
- Presence of gait impairment as defined by any one of the below:
- a UPDRS Part 2 Item 15 (Walking) with a score of 2 b. UPDRS Part 3 Item 26 (leg Agility) with score of 2 or 3 c. UPDRS Part 3 Item 29 (Gait) with score of 1 or 2
- Availability of a caregiver at home
Key exclusion criteria (6 listed)
- Patients with atypical parkinsonism (e.g., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy Bodies)
- PD with dementia
- PD patients with DBS in-situ
- Severe PD with a Hoehn and Yahr staging of 4 or above
- Low blood pressure with systolic of < 110 mmHg or with postural hypotension as defined by a decrease in systolic and diastolic blood pressure by 20 mmHg and 10mmHg upon standing, respectively)
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 |
|---|---|---|
| cVNSThe cVNS emits a low-voltage 5.56 KHz sinusoidal wave electrical signal bursts lasting 0.9 ms via two flat stimulation contact surfaces. (Figure 2) These bursts repeat once every 38 millisecond (ms). Each set of stimulation will be applied for 2 minutes. Stimulation current can be self-adjusted by the subject. This conventional stimulation waveform was approved by the US FDA for the treatment of migraines. | Device | conventional VNS |
| eVNSThe eVNS emits the company-proprietary low-voltage of 3~8 KHz sine-variant smooth-transition wave electrical signal bursts lasting near 0.9 ms via two flat stimulation contact surfaces. These bursts repeat once in intervals of approximately 40 ms. A potential benefit of this waveform is that it can produce less unpleasant skin sensations at a given current intensity and this may enhance the subject to tolerate higher current intensity than that of the conventional stimulation. | Device | exploratory VNS |
| sVNSThe sVNS delivers mechanical motor vibrations to provide a similar perceptible stimulation feeling to the skin. No electrical stimulations are delivered. The device that delivers the sham stimulation is identical in appearance, weight, and user interface. A button to adjust "stimulation current" is also available in the sham device so as to allow the subject/caregiver to adjust the "stimulation current" | Device | sham VNS |
Primary outcome
Change of gait
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Timed UP and Go test: Participant sits back in a standard armchair with their back against the chair and hands resting on the armrests. Regular footwear and usual walking aids (like a cane or walker) are used. On the word "Go", the person stands up, walks a distance of 3 meters (10 feet) to a marked line or cone at a normal, safe pace, turns around, walks back to the chair, and sits down again. A stopwatch starts the moment the word "Go" is spoken and stops the moment the person's buttocks touch the seat. The results in second will be interpret to assist mobility and risk of falling. The longer the time, the high risk of fall
Severity and progression of Parkinson's disease
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Using Unified Parkinson's Disease Rating Scale to motor and non-motor symptoms. Score from 0 to 4. 0 is normal while 4 is severe/marked impairment
Quantitative Gait Assessment
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Using an app to track the mobility of participants in a 20 sec walking
Cognitive status
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Using Hong Kong Montreal Cognitive Assessment to evaluate the cognitive status. score from 0-30. The lower the score, the more cognitive impaired.
Change in mood
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Using Geriatric depression scale which contain 15 questions. Score from 0-15. The higher the score, the more severe the depressed mood
3 secondary outcomes
Change of blood pressure
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Safety measures- record of adverse event and serious adverse event
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Electrocardiogram
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
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 3 Nov 2026.
- Background: PubMed 35684575Castro JI, Valencia Llano CH, Tenorio DL, Saavedra M, Zapata P, Navia-Porras DP, Delgado-Ospina J, Chaur MN, Hernandez JHM, Grande-Tovar CD. Biocompatibility Assessment of Polylactic Acid (PLA) and Nanobioglass (n-BG) Nanocomposites for Biomedical Applications. Molecules. 2022 Jun 6;27(11):3640. doi: 10.3390/molecules27113640.
- Background: PubMed 40057881Eissazade N, Eghdami S, Rohani M, Ajdari A, Fereshtehnejad SM, Fasano A, Khoeini T. Noninvasive Vagus Nerve Stimulation in Parkinson's Disease: A Systematic Review. Neuromodulation. 2025 Jun;28(4):641-651. doi: 10.1016/j.neurom.2025.01.012. Epub 2025 Mar 6.
- Background: PubMed 38384731Mondal B, Choudhury S, Banerjee R, Roy A, Chatterjee K, Basu P, Singh R, Halder S, Shubham S, Baker SN, Baker MR, Kumar H. Effects of non-invasive vagus nerve stimulation on clinical symptoms and molecular biomarkers in Parkinson's disease. Front Aging Neurosci. 2024 Feb 7;15:1331575. doi: 10.3389/fnagi.2023.1331575. eCollection 2023.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication will be shared
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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.
Questions about this trial
What is this clinical trial studying?
A study testing cVNS, eVNS and sVNS in people with Idiopathic Parkinson Disease, run by Chinese University of Hong Kong.
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 6 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 3 Nov 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. Some participants in this study may receive a placebo. 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?
Contact Pauline Kwan, Master's Degree (+852 26352160, paulinekwan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of gait (time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07908498, which also lists 3 linked publications.
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 3 Nov 2026.