Tests nerve stimulation to ease apathy in Parkinson's disease
Tests ear-based vagus nerve stimulation against a sham device in people with Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease
Key facts
- Where
- Hefei, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 90 years old?
Source: NCT07118956, who can take part
Where in China
- Cognitive Neuropsychology Lab Anhui Medical UniversityHefei, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anhui Medical University
- Trial code
- NCT07118956
- Record updated
- 19 November 2025
- Original description
The goal of this clinical trial is to learn whether 100HZ respiratory-gated vagus nerve stimulation (RAVANS) can improve the non-motor symptoms in people with Parkinson's disease (PD). It will also learn the safety of 100HZ RAVANS. The main questions it aims to answer are:Read full original descriptionShow less
Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Trial
The goal of this clinical trial is to learn whether 100HZ respiratory-gated vagus nerve stimulation (RAVANS) can improve the non-motor symptoms in people with Parkinson's disease (PD). It will also learn the safety of 100HZ RAVANS. The main questions it aims to answer are:
Can 100HZ RAVANS improve apathy in people with PD? Did the participants have any side effects or safety issues when undergoing 100HZ RAVANS? Researchers compared 100HZ RAVANS with sham stimulation (low-dose stimulation of the same site and treatment parameters) to see if 100HZ RAVANS could improve non-motor symptoms in patients with PD.
Participants will:
Receive 100HZ RAVANS or sham stimulation for 2 weeks. Neuropsychological assessment, imaging and biological sample collection were conducted before and after the entire cycle.
Inclusion: Meet the diagnostic criteria for idiopathic Parkinson's disease (based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015 version)); Patients with Apathy Motivation Index (AMI) score >1.7; 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; Demonstrate good compliance and adherence, capable of completing behavioral tests and taVNS therapy; Mini-Mental State Examination (MMSE) score ≥22; Meet safety criteria for MRI screening.
Exclusion: Prior brain MRI/CT showing focal brain lesions or severe white matter disease (Fazekas grade 3 or higher); Secondary parkinsonism (e.g., vascular parkinsonism, drug-induced parkinsonism); History of severe traumatic brain injury, neurosurgery, or deep brain stimulation (DBS) therapy; Personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure control; Diagnosis of neuropsychiatric disorders other than Parkinson's disease; 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; Severe systemic comorbidities (e.g., hepatic/renal failure, arrhythmias, organic heart disease); Contraindications to taVNS, such as cardiac pacemakers, post-DBS surgery, or auricular pathologies (e.g., tympanic membrane perforation); Participation in any clinical trial within the past 3 months; Pregnant/lactating women or subjects (including males) planning pregnancy within 6 months.