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Table 4 Data Collection Summary for Primary and Secondary Outcome Measures

From: Identifying response and predictive biomarkers for Transcranial magnetic stimulation outcomes: protocol and rationale for a mechanistic study of functional neuroimaging and behavioral biomarkers in veterans with Pharmacoresistant depression

 

Enrollment

Baseline

1 Week

Post-treatment

Outcome Measures

    

Primary Outcomes - Neuroimaging (Aim 1)

 Functional MRI

 

  GoNoGo Task

 

X

X

X

  N-Back Working Memory Task

 

X

X

X

  Resting State

 

X

X

X

 Structural MRI

 

  T1 Anatomical

 

X

 

X

Secondary Outcomes - Cognitive-Behavioral Measures (Aim 2)

 CNS Vital Signs Battery (SDC, Stroop, SAT, CPT Subtests)

 

X

X

X

 Webneuro Abbreviated Version (GoNoGo and N-Back Subtests)

 

X

X

X

Secondary Outcomes - Clinical Outcome Measures (Aim 3)

 Quick Inventory of Depressive Symptoms (QIDS)- Self Report Form

 

X

X

X

 Veterans’ RAND 36-item Health Survey (VR-36)

 

X

X

X

 Columbia-Suicide Severity Rating Scale (C-SSRS)

 

X

X

X

  1. Data collection occurs at 4 time points as shown above. Enrollment and Baseline research sessions occur prior to the commencement of TMS treatment session 1. The 1 Week research session occurs after completion of the first TMS treatment sessions within the first week, targeting the first 5 TMS sessions. The Post-treatment research session occurs after completion of TMS treatment, targeting 30 TMS sessions