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Timing ear stimulation to breathing for low motivation

Researchers study nerve stimulation at the ear, timed with breathing, to examine apathy and other non-movement symptoms in Parkinson’s.

Testing a treatment or activity · Study reference: NCT07118956

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported actual date)
2025-05-01
Main measurements finished (planned)
2027-05-01
Study finished (planned)
2028-05-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 40 years to 90 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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).
Full study name & original research details

Official study title

Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Trial

Short title used by the registry

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

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: 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.

Further description from the registry

This study employs a double-blind, sham-controlled design to further validate the effects of 100Hz RAVANS on apathy . Patients were randomized into real or sham stimulation groups. Both groups will receive RAVANS once daily, with each session lasting 30 minutes, for a total duration of two weeks. The study design will include neuropsychological assessments, imaging, and biological specimen collection before and after the entire cycle.

Conditions reported: Parkinson Disease; Apathy; Non-motor Symptoms; Vagus Nerve Stimulation

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Active RAVANS; Sham RAVANS
Phases
NA
Sponsor
Anhui Medical University
Start date reported by registry
2025-05-01 (actual)

Registry updated: 2025-11-19 · Status last verified by the registry submitter: 2025-05

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Rong Ye, Ph.D. · +8615656050129 · ronye.uk@gmail.com

Panpan Hu, Ph.D. · +8655162923704 · hpppanda9@126.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, China

Recruiting

Kai Wang, Ph.D. · +8655162923704 · Wangkai1964@126.com

Panpan Hu, M.D. · +8613515602285 · hpppanda9@126.com

Facility not reported

China

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.