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A Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: 1 to 2v6 Show 5 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Primary completion date: Oct 1, 2026 to Dec 1, 2026
    • Secondary endpoints: 7 to 8
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 3 words
  2. Re-verified, no change to tracked fieldsv5
  3. Eligibility criteria revisedv4
  4. Study Status, Eligibilityv3
  5. Eligibility criteria expanded, about 16 wordsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the effects of different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS) on motor and non-motor symptoms in people with Parkinson's disease. The main questions it aims to answer are: Which mode and frequency of taVNS is most effective in improving motor or non-motor symptoms? Are there any side effects or safety concerns with different taVNS frequencies? Researchers will compare three types of taVNS: 25 Hz non-expiratory gated, 25 Hz expiratory gated, and 100 Hz expiratory gated stimulation. Participants will: Receive each type of taVNS in three 2-week cycles, with 2-month breaks between cycles Undergo neuropsychological assessments, imaging, eye-tracking, and biological sample collection before and after each cycle.
Trial Details
NCT Number NCT06642454
Lead Sponsor Anhui Medical University
Conditions
(from sponsor)		 Parkinson Disease, Apathy, Sleep Disorder, Motor Disorders, Mood Disorders
Related terms Lethargy, Mood Disorders, Motor Disorders, Parkinson Disease, Sleep Wake Disorders
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov