Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorAnhui Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the diagnostic criteria for idiopathic Parkinson's disease (based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015 version)).
Patients with Apathy Motivation Index (AMI) score >1.7.
All PD patients must be on stable, standardized medication regimens with no adjustments to medications for at least 1 month prior to the study and throughout the study period.
Demonstrate good compliance and adherence, capable of completing behavioral tests and taVNS therapy.
Disqualifiers
Prior brain MRI/CT showing focal brain lesions or severe white matter disease (Fazekas grade 3 or higher).
Secondary parkinsonism (e.g., vascular parkinsonism, drug-induced parkinsonism).
History of severe traumatic brain injury, neurosurgery, or deep brain stimulation (DBS) therapy.
Personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure control.
Trial design
Design model
Parallel
Treatments tested in this trial
Active RAVANS
Other interventionReal 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.
Sham RAVANS
Other interventionSham 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active respiratory-gated transcutaneous auricular vagus nerve stimulation (RAVANS)Experimental treatment 1 intervention
Group B: Sham RAVANSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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; 6weeks; 8weeks; 10 weeksSecondary outcomes
1
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; 6weeks; 8weeks; 10 weeks2
AMI subscales
AMI has three subscale dimensions including behavioral activation, social motivation and emotional sensitivity.
Time frame
baseline; 2 weeks; 6weeks; 8weeks; 10 weeks3
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.
Time frame
baseline; 2 weeks; 10 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov