Meditation Accelerated Brain Stimulation for Depression

Study Overview
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Brief Summary
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Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from  15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention.

Detailed Description
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Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from  15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention. Meditative internal focus has been shown to benefit depression. Our own research shows that the neural correlates of attention-to-breath are associated with greater mindfulness. Hence, in this study we will pair breath training with rTMS neuro-stimulation.

Official Title
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Meditation Accelerated Brain Stimulation for Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Medi1TMS
* Device: Medi2TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe depression (PHQ-9 scale score >9 with confirmation using the Structured Clinical Interview for DSM-5 Disorders) treatment refractory to antidepressants (i.e. failed 1-3 antidepressants in current episode) or intolerant to antidepressants (i.e. tried 2 antidepressant of inadequate dose/duration in current episode) Exclusion Criteria: active substance abuse/dependence psychotic disorders any factor that increases risk of TMS (metal implants/history of stroke/seizure disorder). displaying acutely suicidal behaviors on the Columbia Suicide Severity Rating Scale.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medi1TMS<br>rTMS theta-burst protocol paired with a consistent attention-to-breath task | Device: Medi1TMS<br>* rTMS theta-burst protocol paired with a consistent attention-to-breath task<br>|
| Active Comparator: Medi2TMS<br>rTMS theta-burst protocol paired with an intermittent deep breathing task | Device: Medi2TMS<br>* rTMS theta-burst protocol paired with an intermittent deep breathing task<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Clinical Depression (Remission) | PHQ9 depression scale | up to 6 weeks | 
| Change from baseline brain activity in attention-to-breath task | Electroencephalography (EEG) power in attention-to-breath task | up to 6 weeks |