Recruiting

Algorithmic State Space

Sponsor:

Baylor College of Medicine

Code:

NCT05283811

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 10 - 64

Healthy Volunteers: Not accepted

Interventions

NEUROPACE RNS SYSTEM

EMU

Study Details

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.

Conditions

Epilepsy

Study ID

NCT05283811

Start date

Jun 1, 2021

Status verified date

Jul, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 64

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

205 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Epilepsy Monitoring Unit

Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit

other: Neuropace RNS Device

Patients are implanted with RNS device to treat their seizure activity

Interventions

NEUROPACE RNS SYSTEM

This device is indicated as a therapy in reducing the frequency of seizures in individuals

EMU

Patients are admitted to the Epilepsy Monitoring Unit for observation of seizure activity prior to further treatment

Primary outcome measure

  • Behavioral performance (Accuracy as fraction of correct responses) [ Time Frame: 7-14 days of behavioral performance collection ]
  • Neurophysiological activity (single-neuron activity in spikes/second) [ Time Frame: 7-14 days of neural activity collection ]

Central Contacts and Locations

Central contacts

Sameer Sheth, MD, PhD

713-798-5060sasheth@bcm.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Sameer A Sheth, MD, PhD

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Single-neuron
  • Local-field potentials

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-07-06.