60
Participants
Start Date
May 24, 2023
Primary Completion Date
July 21, 2027
Study Completion Date
September 30, 2027
transcutaneous Auricular neurostimulation - Active
Active auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved
transcutaneous auricular neurostimulation - Sham
Sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX) but will not deliver prolonged stimulation.
RECRUITING
University of Texas Medical Branch, Galveston
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Medical University of South Carolina
OTHER
The University of Texas Medical Branch, Galveston
OTHER