NCT07118956Recruiting
Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving 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
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 May 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 May 2027
- Lead sponsor
- Anhui Medical University
- Diseases
- Parkinson disease
- NCT number
- NCT07118956
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 May 2025 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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).
Other
- Participation in any clinical trial within the past 3 months.
- Pregnant/lactating women or subjects (including males) planning pregnancy within 6 months.
Who the study is looking for
- 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.
Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cognitive Neuropsychology Lab Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.