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Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Sponsor: Chinese University of Hong Kong
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 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.
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-11-20
Completion Date
2028-06-30
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
cVNS
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.
eVNS
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.
sVNS
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"