30
Participants
Start Date
January 5, 2023
Primary Completion Date
August 1, 2025
Study Completion Date
August 1, 2025
Transcutaneous auricular vagus nerve stimulation
The device to be used is the Roscoe Medical TENS 7000, a commercially available handheld electrical pulse generator, and an ear clip to be placed at the left ear for stimulation. Custom-made ear clips with electrode gel will be placed near the entrance to the canal of the ear to provide stimulation to the auricular branch. The handheld electrical pulse generator will be programmed to deliver electrical stimulation pulses to the cymba concha stimulating the auricular branch of the vagus nerve.
Sham device
The device will appear to function but no electrical stimulation will be delivered.
RECRUITING
Cohen Children's Medical Center, New Hyde Park
RECRUITING
Children's Hospital of Philadelphia, Philadelphia
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Northwell Health
OTHER