Transcranial magnetic stimulation(TMS) is a non-invasive form of brain stimulation that is cleared by the United States Food and Drug Administration (FDA) for depression. Conventional TMS involves daily weekday treatments for 6-8 weeks. These treatments are targeted using each person's scalp measurements. With conventional TMS, approximately 50-55% of people show a 50% or more improvement in depressive symptoms (in other words, they "respond" to treatment).
Studies are trying to make TMS work better and faster. A new form of TMS called accelerated TMS (aTMS) involves mutliple treatments a day. One specific aTMS protocol involves 10 treatments per day for 5 days. These treatments are targeted using each person's brain scan (magentic resonance imaging, MRI). With this specific aTMS protocol, approximately 70-90% of people show a 50% or more imporvement in depressive symptoms. While these results are exciting, scientists are not sure why this specific aTMS protocol works better than conventional TMS. It could be the dose and schedule of treatment, or it could be the MRI-based targeting. Answering this question is important because MRI-based targeting is expensive and difficult to do in many settings.
This study aims to determine if MRI-based targeting is better than scalp-based targeting for aTMS for depression. In this study, everyone who enrolls and meets criteria will be randomly assigned to MRI- versus scalp-based aTMS targeting.
Age 22-80
English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
Primary diagnosis of major depressive disorder per DSM-V criteria (Quick Structured Clinical Interview for DSM-5)
>20 on Beck Depression Inventory (BDI)
None
Parallel
Transcranial Magnetic Stimulation
Procedure/SurgeryTranscranial magnetic stimulation (TMS) is a focal, non-invasive form of brain stimulation that has FDA clearance for depression. In this study, a form of TMS called accelerated intermittent theta burst stimulation (aiTBS) will be administered under the supervision of a physician with TMS expertise.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Depression severity rating scale (0-60, higher numbers indicate higher depressive symptom severity). The MADRS is a clinician rated scale consisting of 10 items, with each item scored on a 7 point scale. For the primary outcome, investigators will assess MADRS as a continuous variable (i.e., MADRS change from baseline to one month after treatment) using a mixed-effects model for repeated measures (MMRM). The model will include group assignment, baseline MADRS score, assessment time point, and time point by treatment interaction as explanatory variables. Hypothesis: There will be a significant group x time interaction on MADRS score from baseline, immediately post-treatment (Day 5), one-week post-treatment, and one-month post-treatment.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Depression severity rating scale (0-60, higher numbers indicate higher depressive symptom severity). The MADRS is a clinician rated scale consisting of 10 items, with each item scored on a 7 point scale. For the secondary outcomes, investigators will assess MADRS as a categorical variable (i.e., MADRS response defined as ≥ 50% improvement one month after treatment) using a generalized estimating equations approach (GEE). Hypothesis: One month after treatment, there will be a significantly larger response rate (≥ 50% MADRS improvement) in the imaging- vs. scalp-targeted group using a z-test for proportions. This response rate will be used to calculate an absolute risk reduction and a "number needed to scan" (NNS) with confidence intervals.
Relationship between treatment target location and response in scalp-targeted aTMS for MDD
The correlation between clinical improvement (i.e., BDI-II) and the distance between the actual (stimulated) scalp-based target and the (predicted but not stimulated) imaging-based target. The BDI-II is a depression severity rating scales (0-63, higher numbers indicate higher severity). Mediation analyses that includes the mediator variable (i.e., distance) in the multivariable model for the outcome (i.e., MADRS improvement). Investigators will implement a form (i.e., counterfactual-based) causal mediation analysis that estimates the controlled direct and indirect effects and the bias-corrected bootstrap confidence intervals while controlling for confounders such as age, sex, and other related variables (e.g., baseline antidepressant use, etc.). Hypothesis: In the scalp-targeted aTMS group, clinical improvement will negatively correlate with the distance between the actual (stimulated) scalp-based target and the (predicted but not stimulated) imaging-based target.
Beck Depression Inventory (BDI)
Depression severity rating scales (0-63, higher numbers indicate higher severity)
Beck Anxiety Inventory (BAI)
Anxiety severity rating scale (0-63, higher numbers indicate higher severity)
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Brigham and Women's Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
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