Actively Recruiting
Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing
Led by Baylor College of Medicine · Updated on 2025-10-27
84
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women (non-pregnant) between ages 22 and 70
- Diagnosis of major depressive disorder as primary diagnosis with current or recurrent major depressive episode
- Current major depressive episode lasting 24 months or more and/or at least 2 lifetime depressive episodes
- Treatment resistance defined by failure to respond to at least four adequate depression treatments from two categories
- Prior trial of electroconvulsive therapy (ECT) with non-response, relapse, poor tolerance, or refusal
- Hamilton Depression Rating Scale-17 item score of 20 or higher on two assessments over one month
- Montgomery Asberg Rating Scale score of 27 or higher one week before surgery
- At least 6 weeks of prior psychotherapy without sustained response
- Brain MRI within 3 months showing no findings precluding participation
- Stable antidepressant medication for the month before surgery
- Modified mini-mental state examination score of 24 or higher
- Normal thyroid stimulating hormone level within 12 months
- No medical or physical conditions preventing participation
- Able and willing to consent and attend regular visits for at least 12 months post-surgery
- Treating psychiatrist or caregiver present at screening for consent discussion
- Willing to sign treatment contract and allow communication between research team and healthcare providers
- Both male and female patients undergoing intracranial electrode placement for epilepsy evaluation
You will not qualify if you...
- Any lifetime history of psychotic disorders such as schizophrenia or schizoaffective disorder
- Bipolar disorder with rapid cycling or recent manic hospitalization within 5 years
- Significant Cluster A or B personality disorder
- Alcohol or substance use disorder within 6 months (excluding nicotine)
- Positive urine drug test for illicit drugs
- Suicidal intent, attempt, or behavior within past year
- Neurological or medical conditions making surgery unsafe
- History or high risk of seizures beyond epilepsy diagnosis
- Medical contraindications to surgery such as infection
- Coagulopathy or abnormal blood clotting parameters
- Blood pressure 180/110 mmHg or higher with cardiovascular disease
- Participation in another trial within 90 days
- Implanted stimulation devices like pacemakers or neurostimulators
- Pregnancy or plans to become pregnant within 24 months
- Need for MRI or diathermy during study
- Chronic use of anticoagulants or antiplatelet agents that cannot be safely stopped
- Any psychiatric, neurological, or medical condition making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kelly Bijanki, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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