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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous auricular vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Apathy, Sleep Disorder, Motor Disorders. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This study employs a three-cycle crossover design to compare the effects of three different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS). The interventions include: 25 Hz non-expiratory gated taVNS, 25 Hz expiratory gated taVNS, and 100 Hz expiratory gated taVNS. Participants will be randomly assigned to one of three groups, with each group receiving a different intervention during each cycle, lasting 2 weeks per cycle. A 2-month washout period will be implemented between cycles to eliminate any carryover effects.The study design will include neuropsychological assessments, imaging, eye-tracking data collection, and biological specimen collection before and after each intervention.
Interventions
- Other Transcutaneous auricular vagus nerve stimulation
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.
Primary outcome measures
- Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
- Non-Motor Symptoms Scale, Second Version (NMSS-2) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
Secondary outcome measures (8)
- Apathy Motivation Index (AMI) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
- Apathy Evaluation Scale (AES) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
- Fatigue Scale-14 (FS-14) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
- REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
- Hamilton Anxiety Rating Scale (HAMA) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
- Hamilton Depression Rating Scale (HAMD-17) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
- Epworth Sleepiness Scale (ESS) [Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
Eligibility criteria
Inclusion criteria
- Age: 40 years or older.
- Confirmed diagnosis of Parkinson's disease (PD) per the United Kingdom Brain Bank Criteria by a neurologist specialized in movement disorders.
- Participants must be on a stable dose of all medications for at least 2 weeks, with no planned adjustments to anti-PD medications for the next 3 months.
- In the second version of the Non-Motor Symptoms Scale (NMSS-2) for Parkinson's disease, a score of ≥1 is assigned to either question 4 or question 8.
- Participants must be in good mental health and capable of completing behavioral tests and transcutaneous auricular vagus nerve stimulation.
Exclusion criteria
- Mini-Mental State Examination (MMSE) score <24.
- History of head injury, stroke, or other neurological disorders.
- Includes implanted cardiac pacemakers post-DBS operation, local infections, ear loss, or metal implants at the stimulation site.
- Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
- Inability to complete follow-up assessments.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Cognitive Neuropsychology Lab Anhui Medical University — Hefei
- Cognitive Neuropsychology Lab Anhui Medical University — Hefei
Identifiers
NCT: NCT06642454 · PD-TaVNS-OPEN