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
Plain-Language Summary
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.