22
Participants
Start Date
January 29, 2024
Primary Completion Date
January 31, 2025
Study Completion Date
June 30, 2025
Transcutaneous vagus nerve stimulation
The Parasym Plus device (https://parasym.io) is a transcutaneous auricular vagus nerve stimulator that has been deemed non-significant risk (NSR) by the FDA. Transcutaneous auricular vagus nerve stimulator is a non-significant risk device, as it involves electrical stimulation of the external ear using an ear clip, with no invasive components. The stimulation parameters will be limited to the confines of existing published data. tVNS is safe and well tolerated at doses tested in research studies. The Parasym device is considered low risk when used in accordance with the instructions for use. Participants will be properly trained to use the device, and those with contraindications will be excluded for extra precaution. A low incidence of skin irritation has been reported. No serious adverse events have been reported.
RECRUITING
Casa Colina Hospital and Centers for Healthcare, Pomona
Foundation for Physical Medicine and Rehabilitation
OTHER
Casa Colina Hospital and Centers for Healthcare
OTHER