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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 Hz non-expiratory gated taVNS | Experimental | 25 Hz non-expiratory gated transcutaneous auricular vagus nerve stimulation |
|
| 25 Hz expiratory gated taVNS | Experimental | 25 Hz expiratory gated transcutaneous auricular vagus nerve stimulation |
|
| 100 Hz expiratory gated taVNS | Experimental | 100 Hz expiratory gated transcutaneous auricular vagus nerve stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) | The Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III) is the gold standard, clinician-administered motor examination for Parkinson's disease. It is a semi-quantitative scale comprising 18 items assessing core motor features-tremor, rigidity, bradykinesia, and postural/gait dysfunction. Each item is scored from 0 (normal) to 4 (severe), with a total possible score of 108. As the primary endpoint in clinical trials, it objectively quantifies motor disability severity and treatment response. | 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. | Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Apathy Motivation Index (AMI) | Apathy Motivation Index (AMI) The AMI is used to assess levels of apathy across behavioral, emotional, and cognitive domains. It provides a comprehensive measure of motivation deficits. | Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks |
| Apathy Evaluation Scale (AES) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Neuropsychology Lab Anhui Medical University | Hefei | Anhui | 230022 | China | ||
| Cognitive Neuropsychology Lab Anhui Medical University |
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|
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. |
| 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. | 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. | 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. | 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. | 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. | Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks |
| Epworth Sleepiness Scale (ESS) | The Epworth Sleepiness Scale (ESS) is a standardized self-report questionnaire measuring daytime sleep propensity. It lists eight common situations; respondents rate their likelihood of dozing (0-3) in each. The total score (0-24) quantifies subjective daytime sleepiness. It is a widely used screening tool for sleep disorders and treatment assessment. | Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks |
| Hefei |
| Anhui |
| China |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D053609 | Lethargy |
| D012893 | Sleep Wake Disorders |
| D000068079 | Motor Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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