NCT05283811 Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients
| NCT ID | NCT05283811 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 205 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 205 participants in total. It began in 2021-06-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Humans have a remarkable ability to flexibly interact with the environment. A compelling demonstration of this cognitive flexibility is human's ability to respond correctly to novel contextual situations on the first attempt, without prior rehearsal. The investigators refer to this ability as 'ad hoc self-programming': 'ad hoc' because these new behavioral repertoires are cobbled together on the fly, based on immediate demand, and then discarded when no longer necessary; 'self-programming' because the brain has to configure itself appropriately based on task demands and some combination of prior experience and/or instruction. The overall goal of our research effort is to understand the neurophysiological and computational basis for ad hoc self-programmed behavior. The previous U01 project (NS 108923) focused on how these programs of action are initially created. The results thus far have revealed tantalizing notions of how the brain represents these programs and navigates through the programs. In this proposal, therefore, the investigators focus on the question of how these mental programs are executed. Based on the preliminary findings and critical conceptual work, the investigators propose that the medial temporal lobe (MTL) and ventral prefrontal cortex (vPFC) creates representations of the critical elements of these mental programs, including concepts such as 'rules' and 'locations', to allow for effective navigation through the algorithm. These data suggest the existence of an 'algorithmic state space' represented in medial temporal and prefrontal regions. This proposal aims to understand the neurophysiological underpinnings of this algorithmic state space in humans. By studying humans, the investigators will profit from our species' powerful capacity for generalization to understand how such state spaces are constructed. The investigators therefore leverage the unique opportunities available in human neuroscience research to record from single cells and population-level signals, as well as to use intracranial stimulation for causal testing, to address this challenging problem. In Aim 1 the investigators study the basic representations of algorithmic state space using a novel behavioral task that requires the immediate formation of unique plans of action. Aim 2 directly compares representations of algorithmic state space to that of physical space by juxtaposing balanced versions of spatial and algorithmic tasks in a virtual reality (VR) environment. Finally, in Aim 3, the investigators test hypotheses regarding interactions between vPFC and MTL using intracranial stimulation.
Eligibility Criteria
Inclusion Criteria: * Eligible subjects include both male and female patients, between 10 years of age and 64 years of age, who undergo placement of intracranial electrodes for clinical characterization of epilepsy. Exclusion Criteria: * Grounds for exclusion would include inability to understand and follow instructions, or inability to concentrate sufficiently to achieve a high proportion of correct responses.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05283811 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 64 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05283811 currently recruiting?
Yes, NCT05283811 is actively recruiting participants. Contact the research team at sasheth@bcm.edu for enrollment information.
Where is the NCT05283811 trial being conducted?
This trial is being conducted at Los Angeles, United States, Houston, United States, Salt Lake City, United States.
Who is sponsoring the NCT05283811 clinical trial?
NCT05283811 is sponsored by Baylor College of Medicine. The trial plans to enroll 205 participants.
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