Parkinson DiseaseNCT07118956
Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease
A study testing Active RAVANS in people with Parkinson Disease and Apathy, run by Anhui Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson Disease, Apathy, Non-motor Symptoms
- What is being tested?
- Active RAVANS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Mini-Mental State Examination (MMSE) score ≥22.
- Meet safety criteria for MRI screening.
Who cannot join
- 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.
- Diagnosis of neuropsychiatric disorders other than Parkinson's disease.
- Current use of non-steroidal anti-inflammatory drugs (NSAIDs) or Non-benzodiazepine GABA receptor agonist drug or anticholinergics or corticosteroids, or history of substance abuse or drug addiction.
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- Participation in any clinical trial within the past 3 months.
- Severe systemic comorbidities (e.g., hepatic/renal failure, arrhythmias, organic heart disease).
- Pregnant/lactating women or subjects (including males) planning pregnancy within 6 months.
- Contraindications to taVNS, such as cardiac pacemakers, post-DBS surgery, or auricular pathologies (e.g., tympanic membrane perforation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, 230022
Kai Wang, Ph.D., +8655162923704, Wangkai1964@126.com
Panpan Hu, M.D., +8613515602285, hpppanda9@126.com
About this study
Official title: Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease: A Randomized, Double-blind, Sham-controlled 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease, Apathy, Non-motor Symptoms, Vagus Nerve Stimulation
- Being tested
- Active RAVANS, Sham RAVANS
- Keywords
- Parkinson Disease, Apathy, Non-motor symptoms, Transcutaneous Auricular Vagus Nerve Stimulation
- Medical subject headings
- Parkinson Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RAVANSOther
Also called RAVANS
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.
Sham RAVANSOther
Also called RAVANS
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.
| Study group | Role | What they receive |
|---|---|---|
| Active respiratory-gated transcutaneous auricular vagus nerve stimulation (RAVANS) | Experimental | Participants will receive active RAVANS daily for 2 week. Receives: Other: Active RAVANS |
| Sham RAVANS | Sham comparator | Participants will receive sham RAVANS daily for 2 week. Receives: Other: Sham RAVANS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks
Secondary outcomes (12)
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.
Measured: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks
AMI subscales
AMI has three subscale dimensions including behavioral activation, social motivation and emotional sensitivity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline; 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
- Investigators
- Kai Wang, Ph.D., Principal investigator, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118956
- Sponsor's protocol ID
- PD-TaVNS-RCT
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT07118956
- Acronym / sponsor ID
- PD-TaVNS-RCT
- Conditions
- Parkinson Disease, Apathy, Non-motor Symptoms, Vagus Nerve Stimulation
- Keywords
- Parkinson Disease, Apathy, Non-motor symptoms, Transcutaneous Auricular Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active respiratory-gated transcutaneous auricular vagus nerve stimulation (RAVANS) | Experimental | Other: Active RAVANSParticipants will receive active RAVANS daily for 2 week. |
| Sham RAVANS | Sham comparator | Other: Sham RAVANSParticipants will receive sham RAVANS daily for 2 week. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Mini-Mental State Examination (MMSE) score ≥22.
Key exclusion criteria (10 listed)
- 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.
- Diagnosis of neuropsychiatric disorders other than Parkinson's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active RAVANSAlso: RAVANSReal 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. | Other | Active respiratory-gated transcutaneous auricular vagus nerve stimulation (RAVANS) |
| Sham RAVANSAlso: RAVANSSham 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. | Other | Sham RAVANS |
Primary outcome
Apathy Motivation Index (AMI)
Time frame: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks
The AMI is used to assess levels of apathy across behavioral, emotional, and cognitive domains. It provides a comprehensive measure of motivation deficits.
12 secondary outcomes
Non-Motor Symptoms Scale, Second Version (NMSS-2)
Time frame: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks
AMI subscales
Time frame: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks
Epworth Sleepiness Scale (ESS)
Time frame: baseline; 2 weeks; 10 weeks
Fatigue Scale-14 (FS-14)
Time frame: baseline; 2 weeks; 10 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline; 2 weeks; 10 weeks
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
Time frame: baseline; 2 weeks; 10 weeks
The Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III)
Time frame: baseline; 2 weeks; 10 weeks
The Neuropsychiatric Inventory (NPI)
Time frame: baseline; 2 weeks; 10 weeks
The Hamilton Anxiety Rating Scale (HAMA)
Time frame: baseline; 2 weeks; 10 weeks
The Hamilton Depression Rating Scale (HAMD)
Time frame: baseline; 2 weeks; 10 weeks
Heart Rate Variability (HRV)
Time frame: baseline everyday; during the intervention everyday
Behavioral performance and computational parameters in an effort-based decision-making task
Time frame: baseline; 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kai Wang, Ph.D. principal investigator
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active RAVANS in people with Parkinson Disease and Apathy, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Ye, Ph.D. (+8615656050129, ronye.uk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apathy Motivation Index (AMI) (time frame: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.