RecruitingNot ApplicableNCT07118956

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

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

Sponsor

Anhui Medical University

Enrollment

60 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Apathy Non-motor Symptoms Vagus Nerve Stimulation

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

Min Age: 40 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive nerve stimulation technique called respiratory-gated transcutaneous auricular vagus nerve stimulation (taVNS) to treat apathy and low motivation in people with Parkinson's disease. The device is worn on the ear and delivers gentle electrical signals to the vagus nerve, timed with the patient's breathing. **You may be eligible if...** - You have a confirmed diagnosis of idiopathic Parkinson's disease - You have significant apathy or low motivation (AMI score above 1.7) - Your Parkinson's medications have been stable for at least 1 month and will remain stable during the study - You are able to complete behavioral and cognitive tests **You may NOT be eligible if...** - Your Parkinson's diagnosis is uncertain or secondary (caused by another condition) - You have recently changed your medications - You have a pacemaker or device that could interfere with nerve stimulation - You have severe dementia or psychiatric conditions preventing participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERActive 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.

OTHERSham 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.