20
Participants
Start Date
February 16, 2024
Primary Completion Date
February 16, 2026
Study Completion Date
July 7, 2026
Neurolith Transcranial Pulse Stimulation Active
5hz (200-300 milliseconds) stimulation pulses transcranial pulse stimulation (TPS) will be applied to each of the following five regions twice per session in sequential order with the specified stimulation parameters: left dorsolateral prefrontal cortex and inferior frontal cortex extending to Broca's area (2x800 pulses), right dorsolateral prefrontal cortex and inferior frontal cortex extending to Broca's area (2x800 pulses; ROI volume \~136/164 cms), the left lateral parietal cortex extending to Wernicke's area (2x400 pulses; ROI volume \~122/147 cms), the right lateral parietal cortex extending to Wernicke's area (2x400 pulses; ROI volume \~122/147 cms), and the extended precuneus cortex (2x600 pulses; ROI volume 66/92 cms). With a repetition time of 5hz (0.00333 seconds) per pulse at a total of 6,000 pulses per participant, the duration of stimulation is about 20 minutes, not including transition time between ROI localization.
Neurolith Transcranial Pulse Stimulation Sham
The intervention procedure described in the Active condition above will also be repeated in participants randomized to the Sham procedure, with the exception of the insertion of a lens over the device by the interventionist to prevent stimulation from reaching the brain.
RECRUITING
University of Florida, Gainesville
University of Florida
OTHER