An interventional study of cVNS and eVNS in Idiopathic Parkinson Disease, sponsored by Chinese University of Hong Kong. Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Parkinson Disease
Device: cVNS
Device: eVNS
Device: sVNS
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.
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.
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"
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
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
To investigate any possibility and relativity of AE and SAE with the treatment
Time frame: 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
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
Blood-based biomarkers
Time frame: Baseline, Day 1 stimulation visit, 4 week post-home stimulation visits and 8 week post-home stimulation visits
No study locations are listed for this record.
Plan to share: Yes — only IPD used in the results publication will be shared
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 13 months is below that.
Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →