Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease
NCT ID: NCT07118956
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-01
2028-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active respiratory-gated transcutaneous auricular vagus nerve stimulation (RAVANS)
Participants will receive active RAVANS daily for 2 week.
Active RAVANS
Real RAVANS was performed on the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve according to the Participant's respiratory rhythm. Stimulation parameters: frequency = 100 Hz; pulse width = 200 us, once a day, 30 minutes each time, one second of stimulation occurs during exhalation.
Sham RAVANS
Participants will receive sham RAVANS daily for 2 week.
Sham RAVANS
Sham RAVANS was performed on on the cymba conchae of left ear according to the Participant's respiratory rhythm. Stimulation parameters: frequency = 100 Hz; pulse width = 200 us, once a day, 30 minutes each time, one second of stimulation occurs during exhalation and the interval between stimulus is 29 seconds.
Interventions
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Active RAVANS
Real RAVANS was performed on the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve according to the Participant's respiratory rhythm. Stimulation parameters: frequency = 100 Hz; pulse width = 200 us, once a day, 30 minutes each time, one second of stimulation occurs during exhalation.
Sham RAVANS
Sham RAVANS was performed on on the cymba conchae of left ear according to the Participant's respiratory rhythm. Stimulation parameters: frequency = 100 Hz; pulse width = 200 us, once a day, 30 minutes each time, one second of stimulation occurs during exhalation and the interval between stimulus is 29 seconds.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
40 Years
90 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Head of the Department, Department of Neurology, The First Affiliated Hospital of Anhui Medical University
Principal Investigators
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Kai Wang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Anhui Medical University
Locations
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Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PD-TaVNS-RCT
Identifier Type: -
Identifier Source: org_study_id
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