Comparing different methods of vagus nerve stimulation for Parkinson's disease symptoms
Official title: A Comparative Open-Label Crossover Study of Respiratory-Gated Versus Non-Respiratory-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease
Run by Anhui Medical University · NCT06642454 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing three different ways of using vagus nerve stimulation to see if it can help people with Parkinson's disease feel better by reducing symptoms like tiredness, mood issues, and sleep problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 2 sites (Hefei, Anhui and 1 other locations) |
| Trial ID | NCT06642454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 40 and older with a confirmed diagnosis of Parkinson's disease and stable medication regimens.
✕Probably not a fit
Patients with significant cognitive impairment or other neurological disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of three different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS) in alleviating non-motor symptoms associated with Parkinson's disease. Participants, aged 40 and older with a confirmed diagnosis of Parkinson's, will undergo three 2-week cycles of taVNS, each followed by a 2-month washout period. The study will assess the impact of 25 Hz non-expiratory gated, 25 Hz expiratory gated, and 100 Hz expiratory gated stimulation on symptoms such as apathy, sleep disorders, fatigue, and mood disorders, alongside neuropsychological assessments and biological sample collection.
Why it matters
Potential benefit: If successful, this study could provide a new non-invasive treatment option for managing non-motor symptoms in Parkinson's disease.
How similar studies have gone: While the approach of using taVNS is gaining interest, this specific comparative study design is relatively novel and has not been extensively tested in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 40 years or older. * Confirmed diagnosis of Parkinson's disease (PD) per the United Kingdom Brain Bank Criteria by a neurologist specialized in movement disorders. * Participants must be on a stable dose of all medications for at least 2 weeks, with no planned adjustments to anti-PD medications for the next 3 months. * In the second version of the Non-Motor Symptoms Scale (NMSS-2) for Parkinson's disease, a score of ≥1 is assigned to either question 4 or question 8. * Participants must be in good mental health and capable of completing behavioral tests and transcutaneous auricular vagus nerve stimulation. Exclusion Criteria: * Mini-Mental State Examination (MMSE) score \<24. * History of head injury, stroke, or other neurological disorders. * Includes implanted cardiac pacemakers post-DBS operation, local infections, ear loss, or metal implants at the stimulation site. * Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. * Inability to complete follow-up assessments.
Where it's running
-
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China Recruiting -
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China Recruiting
Study contacts
- Study coordinator: Rong Ye, Ph.D.
- Email: ronye.uk@gmail.com
- Phone: +8615656050129
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.