NCT06642454Enrolling by invitation
A Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
The goal of this clinical trial is to compare the effects of different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS) on motor and non-motor symptoms in people with Parkinson's disease. The main questions it aims to answer are: Which mode and frequency of taVNS is most effective in improving motor or non-motor symptoms? Are there any side effects or safety concerns with different taVNS frequencies? Researchers will compare three types of taVNS: 25 Hz non-expiratory gated, 25 Hz expiratory gated, and 100 Hz expiratory gated stimulation. Participants will: Receive each type of taVNS in three 2-week cycles, with 2-month breaks between cycles Undergo neuropsychological assessments, imaging, eye-tracking, and biological sample collection before and after each cycle.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Oct 2024
- Start date
- Oct 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Anhui Medical University
- Diseases
- Parkinson disease
- NCT number
- NCT06642454
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Oct 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
Other illness
- 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.
Other
- Mini-Mental State Examination (MMSE) score \<24.
- Inability to complete follow-up assessments.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cognitive Neuropsychology Lab Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.