Respiratory-gated auricular vagus nerve stimulation for apathy in Parkinson's disease
Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Trial
This trial will test whether 100 Hz respiratory-gated transcutaneous auricular vagus nerve stimulation can reduce apathy in people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07118956 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, sham-controlled trial comparing 100 Hz respiratory‑gated transcutaneous auricular vagus nerve stimulation (RAVANS) with a low-dose sham stimulation. Participants receive one 30-minute session per day for two weeks, with random assignment to real or sham stimulation. Neuropsychological testing, brain imaging, and biological samples are collected before and after the two-week treatment course to measure changes and monitor safety. The study also tracks adverse events to characterize tolerability of the 100 Hz RAVANS protocol.
Who should consider this trial
Good fit: Ideal candidates are people with idiopathic Parkinson's disease who have clinically significant apathy (AMI > 1.7), adequate cognition (MMSE ≥ 22), are on stable Parkinson's medications, and can comply with daily sessions and MRI safety requirements.
Not a fit: Patients with secondary parkinsonism, prior deep brain stimulation or major focal brain lesions, a history of epilepsy or unexplained loss of consciousness, or very low cognitive function are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, this approach could offer a non-drug option to reduce apathy and improve motivation in people with Parkinson's disease.
How similar studies have performed: Previous small studies of transcutaneous vagus nerve stimulation have shown mixed but promising effects on mood and cognitive symptoms, while respiratory-gated 100 Hz stimulation for apathy in PD remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the diagnostic criteria for idiopathic Parkinson's disease (based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015 version)). 2. Patients with Apathy Motivation Index (AMI) score \>1.7. 3. All PD patients must be on stable, standardized medication regimens with no adjustments to medications for at least 1 month prior to the study and throughout the study period. 4. Demonstrate good compliance and adherence, capable of completing behavioral tests and taVNS therapy. 5. Mini-Mental State Examination (MMSE) score ≥22. 6. Meet safety criteria for MRI screening. Exclusion Criteria: 1. Prior brain MRI/CT showing focal brain lesions or severe white matter disease (Fazekas grade 3 or higher). 2. Secondary parkinsonism (e.g., vascular parkinsonism, drug-induced parkinsonism). 3. History of severe traumatic brain injury, neurosurgery, or deep brain stimulation (DBS) therapy. 4. Personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure control. 5. Diagnosis of neuropsychiatric disorders other than Parkinson's disease. 6. Current use of non-steroidal anti-inflammatory drugs (NSAIDs) or Non-benzodiazepine GABA receptor agonist drug or anticholinergics or corticosteroids, or history of substance abuse or drug addiction. 7. Participation in any clinical trial within the past 3 months. 8. Severe systemic comorbidities (e.g., hepatic/renal failure, arrhythmias, organic heart disease). 9. Pregnant/lactating women or subjects (including males) planning pregnancy within 6 months. 10. Contraindications to taVNS, such as cardiac pacemakers, post-DBS surgery, or auricular pathologies (e.g., tympanic membrane perforation).
Where this trial is running
Hefei, Anhui
- Cognitive Neuropsychology Lab Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Kai Wang, Ph.D. — Anhui Medical University
- 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.