Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease

Launched by ANHUI MEDICAL UNIVERSITY · Aug 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called respiratory-gated transcutaneous auricular vagus nerve stimulation (or 100HZ RAVANS) to see if it can help improve apathy—a lack of motivation or interest—in people with Parkinson’s disease. Apathy is a common non-motor symptom of Parkinson’s that can affect quality of life. The study also wants to find out if this treatment is safe and if there are any side effects. To do this, researchers will compare the 100HZ RAVANS treatment with a “sham” or fake stimulation to see if the real treatment makes a difference.

People who have Parkinson’s disease, show signs of apathy, and meet certain health requirements may be eligible to join. Participants need to have stable medication for Parkinson’s and be able to take part in the tests and treatments. During the study, participants will receive either the real or sham stimulation for two weeks. Before and after this period, they will undergo brain scans, tests of thinking and mood, and provide biological samples to help researchers understand the effects. This study is currently looking for volunteers who want to help find better ways to manage non-motor symptoms of Parkinson’s.

Gender

ALL

Eligibility 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).