Table 3.

Primary clinical and mechanistic outcomes

Clinical outcome	Measure
Aim 1: to demonstrate feasibility and acceptability of at-home sTMS among Veterans with specific substance use disorders (ie, alcohol, cocaine, opioids) in a pilot sham-controlled study
Feasibility Recruitment Retention Adherence	Rate of 2 or more patients per month 50% or higher study assessment completion rate Completion of at least 80% of sTMS treatment sessions
Acceptability	Treatment Satisfaction Questionnaire
Aim 2: to evaluate the safety of at-home sTMS among Veterans with substance use disorders
Safety	Monitor all adverse events that occur during the study using a combination of clinical interviews and spontaneous adverse event reports (coded using the Medical Dictionary of Regulatory Activities), and through systematic self-report using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) All adverse events will be assessed and described in terms of the relationship to the device, relationship to the procedure, severity of the event, subsequent treatment or intervention, and the resolution status All reporting procedures will align with those listed in 21 CFR 812.150

sTMS, synchronised transcranial magnetic stimulation.