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

Anhui Medical University

Status: Enrolling

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

Treatments: Other: Active RAVANS; Other: Sham RAVANS

Study type: Interventional

Funder types: Other

Identifiers

NCT07118956

PD-TaVNS-RCT

Details and patient eligibility

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Active respiratory-gated transcutaneous auricular vagus nerve stimulation (RAVANS)

Experimental group

Description:

Participants will receive active RAVANS daily for 2 week.

Treatment:

Other: Active RAVANS

Sham RAVANS

Sham Comparator group

Description:

Participants will receive sham RAVANS daily for 2 week.

Treatment:

Other: Sham RAVANS