Pediatric Epilepsy

NCT07350551 | Not Yet Recruiting

• 1 other identifier: STU20251324
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (7)

• Intracranial electroencephalography (iEEG) power in the theta band

  Time-frequency analyses of iEEG data during decision making

  5 years

• iEEG high-gamma activity

  Time-frequency analyses of iEEG data during decision making

  5 years

• iEEG theta-gamma phase-amplitude coupling

  Time-frequency analyses of iEEG data during decision making

  5 years

• Decision-making (firing rates)

  Firing rates of neurons (measured in spikes per second) in the frontal and temporal lobes during a decision-making process.

  5 years

• Behavioral accuracy (neuromodulation)

  Measure task accuracy observed in response to small pulses delivered by electrical stimulation during cognitive testing.

  5 years

• Reaction times (neuromodulation)

  Measure reaction times on task observed in response to small pulses delivered by electrical stimulation during cognitive testing.

  5 years

• Firing rate (neuromodulation)

  Measure firing rates of neurons (measured in amplitude across frequency of the bandwidths) in response to pulses of electrical activity during cognitive testing.

  5 years

Study Arms (1)

Interventional Arm (Cognitive testing)

EXPERIMENTAL

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.

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

Interventions

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

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)

Interventional Arm (Cognitive testing)

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Angela V Price, M.D.

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tashinga Mupambo

CONTACT

214-645-1355; Tashinga.Mupambo@UTSouthwestern.edu

Zhongzheng Fu

CONTACT

214-648-3884; zhongzheng.fu@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2032
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)