Reduce apathy through vagus stimulation
- Trial ID
- NCT07118956
- Official Title
- Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Trial
- Goal
- Reduce apathy through vagus stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Anhui Medical University
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease, Apathy, Non-motor Symptoms, Vagus Nerve Stimulation
- Interventions
- Active RAVANS, Sham RAVANS
Summary For Families
The goal is to ease apathy and low motivation in people with Parkinson's by boosting the brain circuits that support arousal and goal-directed behavior. The approach uses respiratory-gated transcutaneous auricular vagus nerve stimulation, which delivers mild electrical pulses to the ear's vagus branch timed with breathing to activate brainstem and cortical networks that influence norepinephrine and related systems tied to attention and motivation; the trial is randomized, double-blind and compares active versus sham stimulation. It is a noninvasive add-on to usual Parkinson's medications, not a replacement, and participants must keep their meds stable. The team is looking for adults 40 to 90 with Parkinson's who have elevated apathy scores (AMI >1.7), MMSE ≥22, and no DBS, epilepsy, major heart or brain disease, or other key exclusions.
Locations
- Cognitive Neuropsychology Lab Anhui Medical University, Hefei, Anhui, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Active RAVANS. The goal is to ease apathy and low motivation in people with Parkinson's by boosting the brain circuits that support arousal and goal-directed behavior. The approach uses respiratory-gated transcutaneous auricular vagus nerve stimulation, which delivers mild electrical pulses to the ear's vagus branch timed with breathing to activate brainstem and cortical networks that influence norepinephrine and related systems tied to attention and motivation; the trial is randomized, double-blind and compares active versus sham stimulation. It is a noninvasive add-on to usual Parkinson's medications, not a replacement, and participants must keep their meds stable. The team is looking for adults 40 to 90 with Parkinson's who have elevated apathy scores (AMI >1.7), MMSE ≥22, and no DBS, epilepsy, major heart or brain disease, or other key exclusions.
- Who can participate?
- Participants must be between 40 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.