Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients

Sponsor
Baylor College of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05283811
Collaborator
(none)
205
3
2
58
68.3
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NEUROPACE RNS SYSTEM
  • Behavioral: EMU
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
205 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Mapping Algorithmic State Space in the Human Brain
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Epilepsy Monitoring Unit

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

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

Other: Neuropace RNS Device

Patients are implanted with RNS device to treat their seizure activity

Device: NEUROPACE RNS SYSTEM
This device is indicated as a therapy in reducing the frequency of seizures in individuals

Outcome Measures

Primary Outcome Measures

  1. Behavioral performance (Accuracy as fraction of correct responses) [7-14 days of behavioral performance collection]

    Patients will be asked to perform a few different novel, computerized tasks where the patients must respond to on-screen stimuli using button presses. Behavior will be assessed in terms of the accuracy of these responses.

  2. Neurophysiological activity (single-neuron activity in spikes/second) [7-14 days of neural activity collection]

    While patients are performing each behavioral task, the investigators will measure neural activity from BlackRock using depth electrodes with the aim of isolating single-neuron activity (for patients in the EMU) and local-field potential activity (for patients in the RNS patients). Neurophysiological activity will be analyzed with the aim of understanding the neural representations underlying cognitive performance during the task.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Los Angeles Los Angeles California United States 90095
2 Baylor College of Medicine Houston Texas United States 77030
3 University of Utah Salt Lake City Utah United States 84112

Sponsors and Collaborators

  • Baylor College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sameer Sheth, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT05283811
Other Study ID Numbers:
  • 1U01NS121472-01
First Posted:
Mar 17, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Sameer Sheth, Associate Professor, Baylor College of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022