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EpCS in Severe Treatment Resistant Depression

2019-10-16 10:39:14 | BioPortfolio

Summary

Purpose: Treatment-resistant depression (TRD) is a leading cause of premature mortality and healthcare costs. Negative stimuli capture the attention of depressed patients. The more entrenched these core attentional processes are, the longer patients remain ill. The parietal Late Positive Potential (LPP) [an event-related potential (ERP) measured by electroencephalography (EEG)], reliably captures biased attention and early affective responses to environmental stimuli. LPP is top-down modulated by the prefrontal cortex (PFC), an important target for depression treatment. Using a combination of anatomical, functional and electric-field simulation localization methods, the investigators will stereotactically implant 15 TRD patients with bilateral EpCS in a 2-phase approach. The investigators will confirm target engagement, reduction of LPP response, as well as examine the relationship between reductions in LPP and changes in depressive symptoms in TRD patients.

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 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.

Study Design

Conditions

Treatment Resistant Depression

Intervention

Epidural Prefrontal Cortical Stimulation (EpCS)

Status

Not yet recruiting

Source

University of Minnesota - Clinical and Translational Science Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:14-0400

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