Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Baylor College of Medicine
- Study ID
- NCT05283811
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 10 Years - 64 Years
- Healthy Volunteers
- Not accepted
Interventions
- NEUROPACE RNS SYSTEM — DEVICEThis device is indicated as a therapy in reducing the frequency of seizures in individuals
- EMU — BEHAVIORALPatients are admitted to the Epilepsy Monitoring Unit for observation of seizure activity prior to further treatment
Study Details
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.
Key Dates
- Start date
- Jun 1, 2021
- Status verified
- Jul 2025
- Primary completion
- Mar 31, 2026
- Completion
- Mar 31, 2026
Study Design
- Enrollment
- 205 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Other: Epilepsy Monitoring UnitPatient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit
- Other: Neuropace RNS DevicePatients are implanted with RNS device to treat their seizure activity
Primary Outcome Measure
Behavioral performance (Accuracy as fraction of correct responses) [ Time Frame: 7-14 days of behavioral performance collection ]
Central Contacts
- Sameer Sheth, MD, PhD713-798-5060
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | Nanthia Suthana |
| Baylor College of Medicine | Houston | Texas | 77030 | Sameer A Sheth, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84112 | - |
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