RecruitingNot ApplicableNCT06665113

Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients

A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients


Sponsor

Kezhong Zhang

Enrollment

12 participants

Start Date

Dec 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.


Eligibility

Min Age: 55 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a gentle, non-invasive technique called transcutaneous auricular vagus nerve stimulation (taVNS) — which delivers mild electrical pulses through the outer ear to stimulate the vagus nerve — can slow the progression of early Parkinson's disease when combined with standard medication. **You may be eligible if...** - You are between 55 and 75 years old - You have been clinically diagnosed with Parkinson's disease within the past 3 years - Your Parkinson's is in an early stage (Hoehn and Yahr stage 2.5 or lower) - You are currently on standard Parkinson's medication **You may NOT be eligible if...** - You have significant memory or thinking problems (low score on a cognitive screening test) - You have taken certain neuroprotective medications (like rasagiline, selegiline, or GLP-1 drugs) within the past 90 days - You have taken medications that interfere with dopamine (antipsychotics, some anti-nausea drugs) in the past 90 days - You have previously received vagus nerve stimulation treatment - You have MRI contraindications (like some implants or severe claustrophobia) or significant brain abnormalities on imaging 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

DEVICEtaVNS real stimulation

For the real stimulation group, two modified point electrodes will deliver stimulation near the auricular branch of the vagus nerve in the left concha cymba. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs; continuous stimulation for 60 seconds, followed by a 10-second off period, repeated for 30 minutes.

DEVICEtaVNS sham stimulation

For the sham stimulation group, two modified point electrodes will deliver stimulation to the earlobes.Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs; continuous stimulation for 60 seconds, followed by a 10-second off period, repeated for 30 minutes.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06665113


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