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.
Who can participate
Age range
3 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring brain signals like theta-gamma coupling and high-gamma activity during decision-making — can you explain what those measurements actually tell researchers about my child's epilepsy, and whether participating would give us any direct information about their condition?
2Since this trial is listed as 'not yet recruiting,' how long might it be before it opens, and should we be pursuing other treatment options or trials in the meantime rather than waiting?
3The trial seems to involve intracranial EEG recordings, which require electrodes placed inside the skull — is my child already being considered for that kind of invasive monitoring as part of their standard care, or would this trial introduce a procedure they wouldn't otherwise need?
4The study appears to measure how the brain responds to neuromodulation by tracking things like reaction times and firing rates — can you help me understand whether the neuromodulation itself is experimental here, and what is currently known about its safety in children with intractable epilepsy?
5Given that my child's epilepsy is described as intractable, what standard or established treatment options have we not yet tried, and would pursuing those first make more sense before considering a research study at this stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intracranial electroencephalography (iEEG) power in the theta band
Timeframe: 5 years
2
iEEG high-gamma activity
Timeframe: 5 years
3
iEEG theta-gamma phase-amplitude coupling
Timeframe: 5 years
4
Decision-making (firing rates)
Timeframe: 5 years
5
Behavioral accuracy (neuromodulation)
Timeframe: 5 years
6
Reaction times (neuromodulation)
Timeframe: 5 years
7
Firing rate (neuromodulation)
Timeframe: 5 years
Trial details
NCT IDNCT07350551
SponsorUniversity of Texas Southwestern Medical Center