NCT07350551 · University of Texas Southwestern Medical Center
Pediatric Epilepsy
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Intracranial electroencephalography (iEEG) power in the theta band
Time frame: 5 years
Time-frequency analyses of iEEG data during decision making
iEEG high-gamma activity
Time frame: 5 years
Time-frequency analyses of iEEG data during decision making
iEEG theta-gamma phase-amplitude coupling
Time frame: 5 years
Time-frequency analyses of iEEG data during decision making
Decision-making (firing rates)
Time frame: 5 years
Firing rates of neurons (measured in spikes per second) in the frontal and temporal lobes during a decision-making process.
Behavioral accuracy (neuromodulation)
Time frame: 5 years
Measure task accuracy observed in response to small pulses delivered by electrical stimulation during cognitive testing.
Reaction times (neuromodulation)
Time frame: 5 years
Measure reaction times on task observed in response to small pulses delivered by electrical stimulation during cognitive testing.
Firing rate (neuromodulation)
Time frame: 5 years
Measure firing rates of neurons (measured in amplitude across frequency of the bandwidths) in response to pulses of electrical activity during cognitive testing.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations