EpCS in Severe Treatment Resistant Depression

Summary

Participation Requirements

Description

Significance of Research Question: TRD patients present with the inability to disengage from negative perceptions and memories, which further dysregulates their mood and prevents them from engaging the outside world with flexibility. The investigators will demonstrate that LPP, a measure of early em...

Significance of Research Question: TRD patients present with the inability to disengage from negative perceptions and memories, which further dysregulates their mood and prevents them from engaging the outside world with flexibility. The investigators will demonstrate that LPP, a measure of early emotional processes, is a valid target for treating TRD. Intermittent bilateral EpCS will directly engage attention allocation networks, modulate LPP and decrease depressive symptoms. Using Bayesian optimization tools, the investigators can explore a larger number of settings than otherwise possible using classic parametric permutations, and reliably establish a sustained effective target engagement over time. Machine learning and an adaptive clinical trial design will offset the relatively small sample size, enable individualized treatments and help demonstrate that intermittent bilateral EpCS is an effective antidepressant treatment option for severe and chronic depression. Objectives (confirm target engagement and demonstrate clinical relevance): To examine the relationship between reductions in LPP and clinical improvement. The investigators will define the optimal interval for adjusting EpCS settings over time and key design elements for a more definitive randomized control trial (RCT). This study also aims to explore other electrophysiology and behavioral measures that can add to the adaptive stimulation parameters adjustments method. Hypothesis: Severe TRD patients with chronic intermittent EpCS therapy will show a sustained lowering of LPP (replication of target engagement) over a 6-month period, and this change will be related to decreases in Hamilton Rating Scale for Depression (HRSD24). This pattern will demonstrate that target engagement (lowering of LPP) is a key mechanism of antidepressant treatment with EpCS.

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