Comparing different methods of vagus nerve stimulation for Parkinson's disease symptoms
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 2 sites (Hefei, Anhui and 1 other locations) |
| Trial ID | NCT06642454 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with a confirmed diagnosis of Parkinson's disease and stable medication regimens.
Not a fit: Patients with significant cognitive impairment or other neurological disorders may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hefei, Anhui and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.