Treatment Resistant DepressionNCT05418894
Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing
A study testing Device: Directional Deep Brain Stimulation in people with Treatment Resistant Depression and Epilepsy, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment Resistant Depression, Epilepsy
- What is being tested?
- Device: Directional Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women (non-pregnant) between ages 22 and 70;
- 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;
- 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);
- 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);
- 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;
- Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17)
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- ≥20;
- 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;
- Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one-week pre-op;
- Lifetime exposure to minimal 6 weeks of psychotherapy without sustained response;
- Must have a brain MRI within 3 months of enrollment that is "normal", according to the radiology report, or does not reveal any findings that in the opinion of the Investigator preclude participation in the study;
- Stable antidepressant medication regimen for the month preceding surgery;
- Modified mini-mental state examination (MMSE) score ≥ 24;
- Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;
- The patient does not have any medical or physical conditions which, in the opinion of the Investigator, make it unlikely the patient will be able to participate for the duration of the study;
- Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months following surgery;
- Must have a treating psychiatrist, a family member, significant other/living partner, a caregiver, or a person known by the subject present at the Screening visit for the discussion about the study before co-signing the informed consent form;
- Willingness to sign Treatment Contract;
- Agrees to be followed at regular intervals by a licensed psychiatrist and to provide written permission allowing any and all forms of communication between the research team and the subject's healthcare providers, for the entirety of the study;
- Both male and female patients who undergo placement of intracranial electrodes for clinical characterization of epilepsy.
Who cannot join
- DSM-5 Axis I Disorders: any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder);
- Bipolar disorder with rapid cycling and history of manic episode requiring hospitalization within the past 5 years;
- Clinically significant Cluster A or B personality disorder;
- Alcohol or substance use disorder within 6 months, excluding nicotine;
- Urine drug test positive for illicit drugs;
- 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;
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- 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);
- 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);
- Any medical contraindication to surgery such as infection;
- 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;
- A blood pressure of ≥ 180/110 mmHg at a single visit and evidence of cardiovascular disease (CVD);
- Participation in another drug, device, or biological trial within 90 days;
- Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators and deep brain stimulators;
- Pregnant or has plans to become pregnant in the next 24 months;
- Anticipated need for MRI;
- Need for Diathermy;
- Chronic use of anticoagulant or anti-platelet agents that cannot be safely stopped for a sufficient duration (minimum 2.5 weeks) in the peri-operative period.
- Any Psychiatric/Neurological/Medical condition that makes the subject, in the opinion of the Investigator, a poor candidate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Kelly Bijanki, 713-798-5060, bijanki@bcm.edu
About this study
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
- Treatment Resistant Depression, Epilepsy
- Being tested
- Device: Directional Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, Neuromodulation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Directional Deep Brain StimulationDevice
Boston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation
| Study group | Role | What they receive |
|---|---|---|
| EMU | No intervention | Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit |
| TRD | Experimental | Not described Receives: Device: Device: Directional Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of streamlines connecting between intracranial stimulation volume and recording volumes.
To characterize structural connectivity using diffusion-weighted neuroimaging, we will calculate the outcome measures of the number of streamlines connecting target points.
Measured: up to 8 weeks
Evoked potentials arising from stimulation.
To characterize short latency mono- or oligo-synaptic connections of the stimulation volumes to sEEG recording positions using the single pulse-evoked potentials (PEP) technique, the outcome measure will be the number of evoked potentials arising from applied stimulation.
Measured: up to 8 weeks
Secondary outcomes (3)
Spectral band power during mood-relevant cognitive task.
We will characterize the electrophysiological function of the affective salience network via the outcome measure of local field potential recordings in terms of power spectral density during mood-relevant cognitive function.
Measured: up to 12 weeks
Spectral band power following applied stimulation.
We will measure the outcome measure of local field potential power spectral density following the application of research stimulation.
Measured: up to 8 weeks
Match score between spectral band power matrix of desired state and stimulation-evoked state.
We will implement a process of template-matching to align stimulation-evoked neural activity patterns with "desirable" neural state signatures, including natural and induced positive mood states, using spatiotemporal correlation matrix decomposition and machine learning dimensionality reduction. The outcome measure will be the degree of correlational match between desired state and various evoked states following stimulation.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Bijanki, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418894
- Sponsor's protocol ID
- 5R01MH127006-02
- Status last verified
- Oct 2025
- First submitted
- 6 Jun 2022
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing
- ClinicalTrials.gov ID
- NCT05418894
- Acronym / sponsor ID
- 5R01MH127006-02
- Conditions
- Treatment Resistant Depression, Epilepsy
- Keywords
- Deep Brain Stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMU | No intervention | –Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit |
| TRD | Experimental | Device: Device: Directional Deep Brain Stimulation |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Men and women (non-pregnant) between ages 22 and 70;
- 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;
- 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);
- 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);
- 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;
Key exclusion criteria (18 listed)
- DSM-5 Axis I Disorders: any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder);
- Bipolar disorder with rapid cycling and history of manic episode requiring hospitalization within the past 5 years;
- Clinically significant Cluster A or B personality disorder;
- Alcohol or substance use disorder within 6 months, excluding nicotine;
- Urine drug test positive for illicit drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Directional Deep Brain StimulationBoston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation | Device | TRD |
Primary outcome
Number of streamlines connecting between intracranial stimulation volume and recording volumes.
Time frame: up to 8 weeks
To characterize structural connectivity using diffusion-weighted neuroimaging, we will calculate the outcome measures of the number of streamlines connecting target points.
Evoked potentials arising from stimulation.
Time frame: up to 8 weeks
To characterize short latency mono- or oligo-synaptic connections of the stimulation volumes to sEEG recording positions using the single pulse-evoked potentials (PEP) technique, the outcome measure will be the number of evoked potentials arising from applied stimulation.
3 secondary outcomes
Spectral band power during mood-relevant cognitive task.
Time frame: up to 12 weeks
Spectral band power following applied stimulation.
Time frame: up to 8 weeks
Match score between spectral band power matrix of desired state and stimulation-evoked state.
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Directional Deep Brain Stimulation in people with Treatment Resistant Depression and Epilepsy, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Bijanki, PhD (713-798-5060, bijanki@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of streamlines connecting between intracranial stimulation volume and recording volumes. (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.