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

Sponsor
Anhui Medical University
Study ID
NCT06642454
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous auricular vagus nerve stimulation — OTHER
    Stimulation Target: Left cymba conchae. 25 Hz Non-Expiratory Gated taVNS: Stimulation is delivered for 30 seconds at a frequency of 25 Hz, followed by a 30-second interval. 25 Hz Expiratory Gated taVNS: One second of stimulation occurs during exhalation at a frequency of 25 Hz. 100 Hz Expiratory Gated taVNS: One second of stimulation is administered during exhalation at a frequency of 100 Hz.

Study Details

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.

Key Dates

First listed
Oct 15, 2024
Start date
Oct 1, 2024
Status verified
Jun 2025
Primary completion
Dec 1, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 25 Hz non-expiratory gated taVNS
    25 Hz non-expiratory gated transcutaneous auricular vagus nerve stimulation
  • Experimental: 25 Hz expiratory gated taVNS
    25 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
  • Experimental: 100 Hz expiratory gated taVNS
    100 Hz expiratory gated transcutaneous auricular vagus nerve stimulation

Primary Outcome Measure

Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) [ Time Frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks ]

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