NCT07118956 Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease
| NCT ID | NCT07118956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Medical University |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-05-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Contact & Investigator
Kai Wang, Ph.D.
PRINCIPAL INVESTIGATOR
Anhui Medical University
Frequently Asked Questions
Who can join the NCT07118956 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07118956 currently recruiting?
Yes, NCT07118956 is actively recruiting participants. Contact the research team at ronye.uk@gmail.com for enrollment information.
Where is the NCT07118956 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07118956 clinical trial?
NCT07118956 is sponsored by Anhui Medical University. The principal investigator is Kai Wang, Ph.D. at Anhui Medical University. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.