This study is currently recruiting Veterans only. The objective of this observational study is to test whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (TMS) can be prospectively replicated in a large ecologically valid sample. We focus on cognitive network connectivity as a predictive biomarker of the clinical effect of TMS, and as a response biomarker of change with TMS. We address this objective through a pragmatic approach in which we recruit patients undergoing routine clinical care and program evaluation in a Veterans Administration multi-site clinical TMS program.
Although repetitive transcranial magnetic stimulation (TMS) is becoming a gold standard treatment for pharmacoresistant depression, we lack neural target biomarkers for identifying who is most likely to respond to TMS and why. To address this gap in knowledge this observational study evaluates neural targets defined by activation and functional connectivity of the dorsolateral prefrontal cortex-anchored cognitive control circuit, regions of the default mode network and attention circuit, and interactions with the subgenual anterior cingulate. The study evaluates whether these targets and interactions between them change in a dose-dependent manner, whether changes in these neural targets correspond to changes in cognitive behavioral performance, and whether baseline and early change in neural target and cognitive behavioral performance predict subsequent symptom severity, suicidality, and quality of life outcomes. This study is designed as a pragmatic, mechanistic observational trial partnering with the National Clinical TMS Program of the Veteran's Health Administration. All veterans will receive a clinical course of TMS as part of their routine care. Those who agree to enrollment in the observational study will be assessed at 'baseline' prior to commencement of their TMS treatment, 'first week' after initiation of TMS (targeting five sessions) and 'post-treatment' at the completion of TMS (targeting 30 sessions). Veterans will be assessed using functional magnetic resonance imaging (fMRI), a cognitive behavioral performance battery, and established questionnaires. To our knowledge, our study will be the first pragmatic, mechanistic observational trial to use fMRI imaging and cognitive-behavioral performance as biomarkers of TMS treatment response in pharmacoresistant MDD.
Study Type
OBSERVATIONAL
Enrollment
100
transcranial magnetic stimulation is delivered as part of routine care and is not managed by this observational study
Stanford University Department of Psychiatry
Stanford, California, United States
Go-NoGo elicited neural circuit function
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
Time frame: Baseline
Go-NoGo elicited neural circuit function
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
Time frame: Up to 2 weeks
Go-NoGo elicited neural circuit function
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
Time frame: Up to 8 weeks
N-Back elicited neural circuit function
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
Time frame: Baseline
N-Back elicited neural circuit function
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
Time frame: Up to 2 weeks
N-Back elicited neural circuit function
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
Time frame: Up to 8 weeks
Resting state neural circuit function
connectivity assessed using functional magnetic resonance imaging during a resting condition
Time frame: Baseline
Resting state neural circuit function
connectivity assessed using functional magnetic resonance imaging during a resting condition
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Time frame: Up to 2 weeks
Resting state neural circuit function
connectivity assessed using functional magnetic resonance imaging during a resting condition
Time frame: Up to 8 weeks
Symbol Digit Coding Test
Cognitive-Behavioral Performance accuracy on the Symbol Digit Coding Test
Time frame: Baseline
Symbol Digit Coding Test
Cognitive-Behavioral Performance accuracy on the Symbol Digit Coding Test
Time frame: Up to 2 weeks
Symbol Digit Coding Test
Cognitive-Behavioral Performance accuracy on the Symbol Digit Coding Test
Time frame: Up to 8 weeks
Stroop Test
Cognitive-Behavioral Performance accuracy and reaction time on the Stroop Test
Time frame: Baseline
Stroop Test
Cognitive-Behavioral Performance accuracy and reaction time on the Stroop Test
Time frame: Up to 2 weeks
Stroop Test
Cognitive-Behavioral Performance accuracy and reaction time on the Stroop Test
Time frame: Up to 8 weeks
Shifting Attention Test
Cognitive-Behavioral Performance accuracy and reaction time on the Shifting Attention Test
Time frame: Baseline
Shifting Attention Test
Cognitive-Behavioral Performance accuracy and reaction time on the Shifting Attention Test
Time frame: Up to 2 weeks
Shifting Attention Test
Cognitive-Behavioral Performance accuracy and reaction time on the Shifting Attention Test
Time frame: Up to 8 weeks
Continuous Performance Test
Cognitive-Behavioral Performance accuracy and reaction time on the Continuous Performance Test platform
Time frame: Baseline
Continuous Performance Test
Cognitive-Behavioral Performance accuracy and reaction time on the Continuous Performance Test platform
Time frame: Up to 2 weeks
Continuous Performance Test
Cognitive-Behavioral Performance accuracy and reaction time on the Continuous Performance Test platform
Time frame: Up to 8 weeks
Depressive Symptoms
Clinical outcome assessed using the Quick Inventory of Depressive Symptoms (QIDS)- Self Report Form. The total score ranges from 0 to 27 with higher scores indicating greater severity.
Time frame: Baseline
Depressive Symptoms
Clinical outcome assessed using the Quick Inventory of Depressive Symptoms (QIDS)- Self Report Form. The total score ranges from 0 to 27 with higher scores indicating greater severity.
Time frame: Up to 2 weeks
Depressive Symptoms
Clinical outcome assessed using the Quick Inventory of Depressive Symptoms (QIDS)- Self Report Form. The total score ranges from 0 to 27 with higher scores indicating greater severity.
Time frame: Up to 8 weeks
Daily function related to quality of life
Clinical outcome assessed using the Veterans' RAND 36-item Health Survey (VR-36). All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
Time frame: Baseline
Daily function related to quality of life
Clinical outcome assessed using the Veterans' RAND 36-item Health Survey (VR-36). All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
Time frame: Up to 2 weeks
Daily function related to quality of life
Clinical outcome assessed using the Veterans' RAND 36-item Health Survey (VR-36). All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
Time frame: Up to 8 weeks
Suicidal ideation
Columbia-Suicide Severity Rating Scale (C-SSRS). The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.
Time frame: Baseline
Suicidal ideation
Columbia-Suicide Severity Rating Scale (C-SSRS). The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.
Time frame: Up to 2 weeks
Suicidal ideation
Columbia-Suicide Severity Rating Scale (C-SSRS). The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.
Time frame: Up to 8 weeks