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This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.
This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease, , aiming to investigate a novel therapeutic approach for delaying PD progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard anti-Parkinson's disease medication treatment + taVNS real stimulation | Experimental | For the real stimulation group, two modified point electrodes will deliver stimulation near the auricular branch of the vagus nerve in the left concha cymba. Each Parkinson's disease patient will receive one 30-minute stimulation session per day(at least 5 days per week) for 270 consecutive days. |
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| Standard anti-Parkinson's disease medication treatment + taVNS sham stimulation | Sham Comparator | For the sham stimulation group, two modified point electrodes will deliver stimulation to the earlobes.Each Parkinson's disease patient will receive one 30-minute stimulation session per day(at least 5 days per week) for 270 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taVNS real stimulation | Device | For the real stimulation group, two modified point electrodes will deliver stimulation near the auricular branch of the vagus nerve in the left concha cymba. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs; continuous stimulation for 60 seconds, followed by a 10-second off period, repeated for 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| MDS-UPDRS-Ⅲ | Used to evaluate the motor function. | baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days |
| Free water in the posterior substantia nigra (DTI) | Used to measure progression of early Parkinson's disease. | baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Scales: MDS-UPDRS-II | Used to evaluate quality of life of PD. | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Step Length、Stride Length、Stride Velocity and Step Length Variability |
| Measure | Description | Time Frame |
|---|---|---|
| Eye-Tracking Technology | Fixation Duration: The length of time the gaze remains on a single point. Saccade Velocity: The speed of eye movements between fixations. Scan Path: The trajectory of eye movements during visual exploration | baseline,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Electroencephalogram (EEG) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kezhong Zhang, Professor | Contact | 400-13770840575 | kezhong_zhang1969@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Kezhong Zhang, Professor | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 211200 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| taVNS sham stimulation | Device | For the sham stimulation group, two modified point electrodes will deliver stimulation to the earlobes.Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs; continuous stimulation for 60 seconds, followed by a 10-second off period, repeated for 30 minutes. |
|
Used to assess the patient's gait disturbances，including the Step Length、Stride Length、Stride Velocity and Step Length Variability
| baseline,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Scales: H&Y stage | Used to evaluate the stage of PD. | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
Measurement: Brain wave activity (measured in microvolts, µV). |
| baseline,180±7 days, 360±7 days, 540±7 days，570±7 days |
| MRI | T1-weighted Imaging: Measurement: Structural brain volume (measured in cubic centimeters, cm³). BOLD fMRI: Measurement: Blood oxygen level-dependent signals (measured in percentage change). Diffusion Tensor Imaging (DTI): Fractional Anisotropy (FA): Measurement: FA values (unitless, scale from 0 to 1). Mean Diffusivity (MD): Measurement: MD values (measured in mm²/s). NM-MRI: Measurement: Neurochemical markers (unit as appropriate). Iron-sensitive MRI: Quantitative Susceptibility Mapping (QSM): Measurement: Susceptibility values (measured in parts per million, ppm). Susceptibility Weighted Imaging (SWI): Measurement: Signal intensity (unitless). R2*: Measurement: Relaxation rate (measured in Hz). | baseline,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Number of participants with the following Serum biomarkers: | Brain-Derived Neurotrophic Factor (BDNF): Measurement: Concentration (measured in ng/mL). Glial Fibrillary Acidic Protein (GFAP): Measurement: Concentration (measured in ng/mL). Neurofilament Light Chain (NFL): Measurement: Concentration (measured in pg/mL). Tau Protein: Measurement: Concentration (measured in pg/mL). Tumor Necrosis Factor Alpha (TNF-α): Measurement: Concentration (measured in pg/mL). Interleukin-6 (IL-6): Measurement: Concentration (measured in pg/mL). Interleukin-1 Beta (IL-1β): Measurement: Concentration (measured in pg/mL). | baseline,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale - Part I (MDS-UPDRS-I) | .Measurement: Score (range: 0-52; higher score indicates worse non-motor function). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Non-Motor Symptoms Scale (NMSS) | Measurement: Score (range: 0-100; higher score indicates more severe non-motor symptoms). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Activities of Daily Living (ADL) Scale | Measurement: Score (range: 0-100; higher score indicates greater independence). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Hamilton Anxiety Scale (HAMA) | Measurement: Score (range: 0-56; higher score indicates greater anxiety). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Hamilton Depression Rating Scale - 24 items (HAMD-24) | Measurement: Score (range: 0-76; higher score indicates greater depression severity). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Apathy Scale (AS) | Measurement: Score (range: 0-42; higher score indicates greater apathy). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Rapid Eye Movement Sleep Behavior Disorder Questionnaire (RBDSQ) | Measurement: Score (range: 0-25; higher score indicates more severe symptoms). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Epworth Sleepiness Scale (ESS) | Measurement: Score (range: 0-24; higher score indicates greater daytime sleepiness). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Montreal Cognitive Assessment (MoCA) | Measurement: Score (range: 0-30; higher score indicates better cognitive function). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Hopkins Verbal Learning Test - Revised (HVLT-R) | Measurement: Score (varies by subscale; higher score indicates better verbal memory). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Judgment of Line Orientation (JLO) | Measurement: Score (range: 0-30; higher score indicates better visual-spatial abilities). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Letter-Number Sequencing (LNS) | Measurement: Score (range: 0-30; higher score indicates better working memory). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Symbol Digit Modalities Test (SDMT) | Measurement: Score (varies based on response time; higher score indicates faster processing speed). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| Levodopa Equivalent Dose (LED) | Measurement: Dose (measured in mg; higher dose indicates greater medication requirement). | baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |