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The goal of this clinical trial is to learn whether 100HZ respiratory-gated vagus nerve stimulation (RAVANS) can improve the non-motor symptoms in people with Parkinson's disease (PD). It will also learn the safety of 100HZ RAVANS. The main questions it aims to answer are:
Can 100HZ RAVANS improve apathy in people with PD? Did the participants have any side effects or safety issues when undergoing 100HZ RAVANS? Researchers compared 100HZ RAVANS with sham stimulation (low-dose stimulation of the same site and treatment parameters) to see if 100HZ RAVANS could improve non-motor symptoms in patients with PD.
Participants will:
Receive 100HZ RAVANS or sham stimulation for 2 weeks. Neuropsychological assessment, imaging and biological sample collection were conducted before and after the entire cycle.
This study employs a double-blind, sham-controlled design to further validate the effects of 100Hz RAVANS on apathy . Patients were randomized into real or sham stimulation groups. Both groups will receive RAVANS once daily, with each session lasting 30 minutes, for a total duration of two weeks. The study design will include neuropsychological assessments, imaging, and biological specimen collection before and after the entire cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active respiratory-gated transcutaneous auricular vagus nerve stimulation (RAVANS) | Experimental | Participants will receive active RAVANS daily for 2 week. |
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| Sham RAVANS | Sham Comparator | Participants will receive sham RAVANS daily for 2 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active RAVANS | Other | Real RAVANS was performed on the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve according to the Participant's respiratory rhythm. Stimulation parameters: frequency = 100 Hz; pulse width = 200 us, once a day, 30 minutes each time, one second of stimulation occurs during exhalation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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; 6weeks; 8weeks; 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Ye, Ph.D. | Contact | +8615656050129 | ronye.uk@gmail.com | |
| Panpan Hu, Ph.D. | Contact | +8655162923704 | hpppanda9@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Kai Wang, Ph.D. | Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Neuropsychology Lab Anhui Medical University | Recruiting | Hefei | Anhui | 230022 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D053609 | Lethargy |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham RAVANS | Other | Sham RAVANS was performed on on the cymba conchae of left ear according to the Participant's respiratory rhythm. Stimulation parameters: frequency = 100 Hz; pulse width = 200 us, once a day, 30 minutes each time, one second of stimulation occurs during exhalation and the interval between stimulus is 29 seconds. |
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| baseline; 2 weeks; 6weeks; 8weeks; 10 weeks |
| AMI subscales | AMI has three subscale dimensions including behavioral activation, social motivation and emotional sensitivity. | baseline; 2 weeks; 6weeks; 8weeks; 10 weeks |
| Epworth Sleepiness Scale (ESS) | The ESS is a widely used self-assessment questionnaire designed to measure daytime sleepiness. It was developed by Dr. Murray Johns in 1991 and is commonly employed in clinical and research settings to evaluate excessive daytime sleepiness , which is often associated with sleep disorders like obstructive sleep apnea ,narcolepsy, or insomnia. | baseline; 2 weeks; 10 weeks |
| 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 |
| 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 |
| 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 |
| The Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III) | The UPDRS-III is a standardized clinical assessment tool used to evaluate the motor symptoms of Parkinson's disease (PD). It is part of the broader UPDRS, which is the most widely accepted scale for assessing the severity and progression of PD. Below is a detailed explanation. | baseline; 2 weeks; 10 weeks |
| The Neuropsychiatric Inventory (NPI) | The Neuropsychiatric Inventory (NPI) is a standardized tool used to assess neuropsychiatric symptoms (such as hallucinations, depression, agitation, etc.) in patients with dementia. | baseline; 2 weeks; 10 weeks |
| The Hamilton Anxiety Rating Scale (HAMA) | The Hamilton Anxiety Rating Scale (HAMA) is a clinician-administered assessment tool widely used in clinical practice to evaluate the severity of anxiety symptoms | baseline; 2 weeks; 10 weeks |
| The Hamilton Depression Rating Scale (HAMD) | The Hamilton Depression Rating Scale (HAMD) is a clinician-administered assessment tool commonly used in clinical practice to evaluate the severity of depressive symptoms. | baseline; 2 weeks; 10 weeks |
| Heart Rate Variability (HRV) | Heart Rate Variability (HRV) is a physiological indicator that assesses the function of the autonomic nervous system (ANS) by analyzing subtle variations in heartbeat intervals (R-R intervals). The vagus nerve serves as the primary pathway of the parasympathetic nervous system. Transcutaneous auricular vagus nerve stimulation (taVNS) enhances parasympathetic nerve activity by stimulating the auricular branch of the vagus nerve. HRV is a critical metric for evaluating the efficacy of this regulatory effect.Each day before treatment, a 5-minute resting HRV is recorded, followed by a 30-minute HRV recording during the intervention. | baseline everyday; during the intervention everyday |
| Behavioral performance and computational parameters in an effort-based decision-making task | The Effort-Based Decision-Making Task is an experimental paradigm used to investigate how individuals weigh effort costs against task rewards under differenct conditions. Behavioral and computational indexes are calculated across varying levels of effort and reward.The main indicators are the selection rate and accuracy rate under different levels of effort and reward | baseline; 2 weeks |
| 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 |