Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)

Study Description: This study is intended to test the safety and potential efficacy of the highdensity theta burst stimulation (hdTBS) paradigm. We hypothesize that hdTBS i) can be safely administered to normal healthy human subjects, and ii) can produce stronger and longer-lasting after-effects than the conventional FDA-approved TBS paradigm. Objectives: Primary Objective: To determine whether hdTBS at the power level of 60% and 80% resting motor threshold can be safely administered to normal healthy human participants. Secondary Objective: To determine whether hdTBS produces stronger and longer-lasting after-effects than the conventional, FDA-approved TBS protocol. Here "after-effects" are defined as alterations in cortical excitability after TMS administration, which can be quantitatively assessed by measuring motor-evoked potential (MEP) before and after an acute session of TMS on the primary motor cortex. Changes in the characteristics and durations of the MEP signal relative to pre-TMS baseline reflect neuromodulation effects of the TMS session. Endpoints: Primary Endpoint: Clinically significant adverse events as collected on the Noninvasive Brain Stimulation (NIBS) monitoring questionnaire and evaluated by the MAI in combination with the serious adverse event reports. Secondary Endpoints: 20 complete datasets at the 80% RMT hdTBS dose that are evaluable for after-effects of hdTBS.