Active RAVANS for Parkinson's (NCT07118956)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Participants will have 30-minute RAVANS sessions once daily for a total duration of two weeks.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.