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Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing

NCT05418894 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-10-27

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Device: 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

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418894 on ClinicalTrials.gov