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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
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.
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China
Unified Parkinson's Disease Rating Scale Part III (UPDRS-III)
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Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Non-Motor Symptoms Scale, Second Version (NMSS-2)
The NMSS-2 is a comprehensive, clinician-administered tool designed to assess the range and severity of non-motor symptoms in individuals with Parkinson's disease. It covers multiple domains including sleep disturbances, mood, cognition, gastrointestinal symptoms, urinary dysfunction, and other non-motor manifestations. This second version of the scale provides an updated and refined assessment framework to capture the broad impact of non-motor symptoms on patients' quality of life.
Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Apathy Motivation Index (AMI)
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Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Apathy Evaluation Scale (AES)
The AES is designed to evaluate the severity of apathy in individuals, focusing on the lack of motivation in behaviors, emotional responsiveness, and cognitive functioning.
Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Fatigue Scale-14 (FS-14)
The FS-14 is a self-report measure used to evaluate fatigue across physical and mental dimensions. It comprises 14 items that assess the severity and impact of fatigue on daily functioning.
Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a standardized tool used to assess sleep quality and disturbances over a one-month time interval. It evaluates seven components of sleep, including subjective sleep quality, latency, duration, and daytime dysfunction.
Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
The RBDSQ is a diagnostic tool used to screen for REM Sleep Behavior Disorder (RBD), focusing on the presence of dream-enactment behaviors and other sleep-related symptoms.
Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Hamilton Anxiety Rating Scale (HAMA)
The HAMA is a clinician-administered scale designed to assess the severity of anxiety symptoms. It covers both psychological and somatic symptoms, providing a comprehensive evaluation of anxiety levels.
Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Hamilton Depression Rating Scale (HAMD-17)
The HAMD-17 is a widely used instrument for assessing the severity of depressive symptoms. It consists of 17 items that evaluate mood, physical symptoms, and cognitive disturbances associated with depression.
Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Epworth Sleepiness Scale (ESS)
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Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
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