Actively Recruiting
Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease
Led by Anhui Medical University · Updated on 2025-11-19
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria for idiopathic Parkinson's disease based on the MDS Clinical Diagnostic Criteria (2015).
- Have an Apathy Motivation Index (AMI) score greater than 1.7.
- Be on stable, standardized Parkinson's medication with no changes for at least 1 month before and during the study.
- Show good compliance and ability to complete behavioral tests and taVNS therapy.
- Have a Mini-Mental State Examination (MMSE) score of 22 or higher.
- Meet safety requirements for MRI screening.
You will not qualify if you...
- Prior brain MRI or CT showing focal brain lesions or severe white matter disease (Fazekas grade 3 or above).
- Secondary parkinsonism, such as vascular or drug-induced parkinsonism.
- History of severe traumatic brain injury, neurosurgery, or deep brain stimulation therapy.
- Personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications.
- Diagnosis of neuropsychiatric disorders other than Parkinson's disease.
- Current use of NSAIDs, non-benzodiazepine GABA receptor agonists, anticholinergics, corticosteroids, or history of substance abuse.
- Participation in any clinical trial within the last 3 months.
- Severe systemic illnesses such as liver or kidney failure, arrhythmias, or organic heart disease.
- Pregnant or breastfeeding women or subjects planning pregnancy within 6 months.
- Contraindications to taVNS including cardiac pacemakers, post-DBS surgery, or ear pathologies such as tympanic membrane perforation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
Research Team
R
Rong Ye, Ph.D.
CONTACT
P
Panpan Hu, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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