Parkinson Disease study: Active RAVANS
Official title Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease
ClinicalTrials.gov ID: NCT07118956
What this study is testing
- What it's testing
- This study wants to find out if a specific type of ear stimulation can improve apathy (a lack of interest or motivation) in people with Parkinson's disease. It also checks if the treatment is safe.
- Who it's for
- People who have Parkinson's disease and experience apathy.
- What's involved
- Participants will wear a small device on their ear that sends gentle electrical pulses for two weeks. They will also complete mental health tests, brain scans, and provide biological samples before and after the treatment.
- Time commitment
- The study lasts two weeks for the treatment, with additional visits for testing before and after.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 90
You may be able to join if
- Meet the diagnostic criteria for idiopathic Parkinson's disease (based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015...
- 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...
- Demonstrate good compliance and adherence, capable of completing behavioral tests and taVNS therapy.
- Mini-Mental State Examination (MMSE) score ≥22.
You likely can't join if
- 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...
See the full eligibility criteria
- 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.
- 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.
- 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 people (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).
The study team makes the final eligibility decision.
Where it is enrolling
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hefei, Anhui, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.