Respiratory-gated auricular vagus nerve stimulation for apathy in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.