RecruitingNot ApplicableNCT05418894

Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing


Sponsor

Baylor College of Medicine

Enrollment

84 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The overall goal of this study is to map the spatiotemporal dynamics of social affective processing and to examine selective modulation of these dynamics in humans undergoing invasive intracranial monitoring for treatment-resistant epilepsy and depression. Pursuing this signal from a novel platform with invasive intracranial recording electrodes provides much-needed spatial and temporal resolution to characterize the neural dynamics of socio-affective processing. The investigators will leverage first-in-human intracranial neural recording opportunities created by a novel therapeutic platform termed "stereotactic electroencephalography-informed deep brain stimulation" (stereo-EEG-informed DBS), as well as the powerful platform of intracranial stereotactic recording and stimulation in patients undergoing epilepsy surgical evaluation at Baylor College of Medicine. The sEEG-informed DBS trial provides unique opportunities for intracranial recording of affect-relevant network regions in patients with treatment-resistant depression (TRD). Recordings in identical regions in epilepsy patients who themselves often demonstrate mild-moderate depressive symptoms will provide a wide dynamic range across the symptom spectrum. To provide critical data on the spatiotemporal dynamics of socio-affective processing the investigators will leverage these two human intracranial recording and stimulation cohorts to study the precise structural, functional, and causal properties of the affective salience network. Greater understanding of the social processing circuitry mediated by the affective salience network may be used to drive therapeutic innovation, pioneering a new paradigm that improves socio-emotional function across a wide variety of neuropsychiatric conditions. The results from this proposal have the potential to improve the lives of patients with dysfunction in social affective processing, with implications for a wide range of neuropsychiatric diseases.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring how the brain processes social and emotional information in people with major depression. Using brain imaging and non-invasive brain stimulation techniques, researchers aim to map these emotional circuits and test whether stimulating them can improve depression symptoms. **You may be eligible if...** - You are between 22 and 70 years old (men or women who are not pregnant) - You have a confirmed diagnosis of major depressive disorder (MDD) as your primary condition - You are currently experiencing a depressive episode - You have tried at least one antidepressant medication that did not work well enough **You may NOT be eligible if...** - You have other major psychiatric conditions (schizophrenia, bipolar disorder, active substance use disorder) - You have active suicidal thoughts or plans - You have metal implants or a pacemaker (for those receiving brain stimulation) - You have a history of seizures or significant neurological conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDevice: Directional Deep Brain Stimulation

Boston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation


Locations(1)

Baylor College of Medicine

Houston, Texas, United States

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NCT05418894


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