An interventional study of Transcutaneous auricular vagus nerve stimulation in Parkinson Disease, Apathy and Sleep Disorder, sponsored by Anhui Medical University. Enrolling by invitation at 2 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Anhui Medical University · Not applicable, Interventional, and Treatment
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Anhui Medical University is the lead sponsor of 104 studies on the registry; 50 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
25 Hz non-expiratory gated transcutaneous auricular vagus nerve stimulation
Other: Transcutaneous auricular vagus nerve stimulation
25 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
Other: Transcutaneous auricular vagus nerve stimulation
100 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
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.
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.
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)
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.
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)
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.
Time frame: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
Plan to share: No
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