Recruiting

Cognition Research

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07350551

Conditions

Epilepsy Intractable

Eligibility Criteria

Sex: All

Age: 3 - 25

Healthy Volunteers: Not accepted

Interventions

Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator

Study Details

Brief summary:

The purpose of the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, making decisions or choices about presented information and self-control. These investigations are critical to better understand human cognition and to design treatments for disorders of learning, memory, decision making and cognitive control.

Conditions

Epilepsy Intractable

Study ID

NCT07350551

Start date

Jul 1, 2026

Status verified date

May, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Candidates will be those who are admitted to the Epilepsy Monitoring Unit and are able to participate in a pre-operative evaluation using depth intracranial electrodes. The candidacy is determined independently by the patient's treating physician as part of the patient's routine medical care.
  • Patients have drug-intractable epilepsy undergoing invasive monitoring in the EMU.

Exclusion Criteria:

  • Determination by clinicians and investigators that a patient is unable to complete the behavioral tasks required for the protocol due to either cognitive limits, psychological limits, or pain.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Interventional Arm (Cognitive testing)

All participants will undergo series of cognitive task testing with some involving tasks contexts such as incentives, cognitive loads, presence of a neutral image or verbal instructions being changed at different times and components where subjects learn and memorize facts and make decisions using such knowledge to obtain Behavioral and Neuronal Recordings of change in task performance.

Interventions

Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator

Devices listed are components of a single intervention that includes: Record patient responses (Cedrus RB series response boxes), record neuronal activity (Neuralynx or BlackRock) from electrodes (Adtech Behnke-Fried), apply intermittent electrical stimulation (Blackrock Cerestim, Natus Nicolet; parameters consistent with safe ranges across reported studies)

Primary outcome measure

  • Intracranial electroencephalography (iEEG) power in the theta band [ Time Frame: 5 years ]
  • iEEG high-gamma activity [ Time Frame: 5 years ]
  • iEEG theta-gamma phase-amplitude coupling [ Time Frame: 5 years ]
  • Decision-making (firing rates) [ Time Frame: 5 years ]
  • Behavioral accuracy (neuromodulation) [ Time Frame: 5 years ]
  • Reaction times (neuromodulation) [ Time Frame: 5 years ]
  • Firing rate (neuromodulation) [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

Children's Medical Center Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Angela Price, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Oct 6, 2026

Last verified

May, 2026

Keywords

  • Epilepsy
  • Decision-making
  • Cognitive control
  • Memory
  • Depth Electrode
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • ADHD (Attention-Deficit/Hyperactivity Disorder)
  • Cognitive development

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.