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RECRUITINGNA

Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing

NCT05418894•Baylor College of Medicine

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

Age

22 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Men and women (non-pregnant) between ages 22 and 70;
•2. DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5 Axis I disorders SCID-5) of major depression disorder (MDD) as the primary diagnosis. A current major depressive episode (MDE), recurrent or single episode with first episode before age 60, secondary to nonpsychotic unipolar major depressive disorder;
•3. Chronic illness with current MDE ≥24 months duration and/or recurrent illness with at least a total of 2 lifetime episodes (including current episode \>12 months);
•4. Treatment resistance (defined by criteria on the Antidepressant Treatment History Form ATHF): Failure (i.e. persistence of the major depressive episode) to respond to a minimum of four adequate depression treatments from at least two different treatment categories (e.g. SSRIs, SNRIs, TCAs, other antidepressants, lithium-addition, irreversible MAOIs, antidepressant augmentation with an atypical antipsychotic medication);
•5. Previous trial of Electroconvulsive Therapy (ECT) (lifetime): either did not respond, relapsed, poorly tolerated or refused. If refused, will discuss reasons and ensure subject understands relative risks of ECT versus DBS. We will try to enrich sample with patients who had previously shown response to ECT (or another intervention) that was partial or un-sustained;
•6. Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17)
•≥20;
•7. The HDRS17 must remain greater than or equal to 20 on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period;
•8. Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one-week pre-op;
•9. Lifetime exposure to minimal 6 weeks of psychotherapy without sustained response;
+10 more criteria

Exclusion Criteria

•1. DSM-5 Axis I Disorders: any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder);
•2. Bipolar disorder with rapid cycling and history of manic episode requiring hospitalization within the past 5 years;
•3. Clinically significant Cluster A or B personality disorder;
•4. Alcohol or substance use disorder within 6 months, excluding nicotine;
•5. Urine drug test positive for illicit drugs;
•6. Any evidence or indication of suicidal intent, suicidal attempt, or suicidal behavior, including but not limited to the C-SSRS score, within the past one year;
•7. Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation);
•8. Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital brain malformation, history of brain injury, neuro-developmental disorder, currently taking medication that is known to lower seizure threshold, or other factors that predispose seizures);
•9. Any medical contraindication to surgery such as infection;
•10. Coagulopathy: Bleeding propensity and/or one of the following: INR \> 1.5; prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec; platelet count \< 100×103/uL;
+8 more criteria

Locations (1)

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

April 1, 2022

Primary Completion Date

March 31, 2027

Completion Date

March 31, 2027

Last Updated

October 27, 2025

Enrollment

ESTIMATED participants

Conditions

Treatment Resistant DepressionEpilepsy

Interventions

Device: Directional Deep Brain Stimulation

DEVICE

Contacts

Kelly Bijanki, PhD

CONTACT

713-798-5060 bijanki@bcm.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

University of Iowa Interventional Psychiatry Service Patient Registry

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition