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NCT05418894 · ClinicalTrials.gov registry record · NA
Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing
A NA study of Epilepsy and Treatment-Resistant Depression, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT05418894: Recruiting NA study of Epilepsy and Treatment-Resistant Depression, sponsored by Baylor College of Medicine.
NCT05418894 is a NA study of Epilepsy and Treatment-Resistant Depression that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 84 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05418894, a NA study of Epilepsy and Treatment-Resistant Depression, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
To characterize structural connectivity using diffusion-weighted neuroimaging, we will calculate the outcome measures of the number of streamlines connecting target points.
Conditions Studied
Interventions
- DEVICE Device: Directional Deep Brain Stimulation
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT05418894 shows while recruiting
NCT05418894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Device: Directional Deep Brain Stimulation is the first listed.
NCT05418894 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05418894 about?
NCT05418894 is a clinical study titled "Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing". 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 ...
What is the current status of trial NCT05418894?
This trial is currently recruiting. It is a NA study. The enrollment target is 84 participants. The study started on 2022-04-01. Estimated completion is 2027-03-31.
What conditions does trial NCT05418894 study?
This clinical trial studies the following conditions: Epilepsy, Treatment-Resistant Depression.
What interventions are being tested in trial NCT05418894?
The interventions under investigation include: Device: Directional Deep Brain Stimulation (DEVICE).
Who is sponsoring clinical trial NCT05418894?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05418894 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05418894's enrollment target sits among peer trials
84 65th of 160 higher than 96 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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