An interventional study of Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator in Epilepsy Intractable, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 3 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Basic science
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.
The knowledge gained from these experiments furthers the understanding of the brain's electrical activity and its relation to epilepsy and to human cognition. This increased knowledge base may lead to insights regarding better treatments for cognitive deficits and to improve epilepsy surgery and other therapies for seizure disorders. Functional mapping is an important element of planning for resection surgery because it enables the surgeon to avoid the resection of brain regions that could be especially crucial to cognitive function. By uncovering the iEEG (Intracranial Electroencephalography) signatures of memory function, functional mapping may be improved, and the risk of post-surgical cognitive impairment following resection could be reduced.
Hypotheses being tested (conceptual: see "Data Analysis" section for specific hypotheses) The study team hypothesizes that specific electrophysiological correlates of successful memory encoding can be identified from the local field potentials recorded from subdural and intracranial depth electrodes. The study team believes that an analysis of local field potentials can provide insight into the organization of functional brain networks involved in memory encoding and retrieval.
Theta Oscillations and Behavior in Rodents Scientists have theorized, based predominantly on research in rodents, that brain oscillations - cyclic changes in the electrical activity recorded from electrodes - play a fundamental role in memory function. In particular, theories of the role of oscillations in cognitive function have focused on a slow rhythm in the 3- to 12-Hz frequency range, which is termed the theta rhythm. These slow oscillations appear prominently in recordings from the rat hippocampus, a region known to be important in learning and memory function across species.
The theta rhythm increases during movement, orienting, a simple form of learning called conditioning, short-term memory, and spatial learning. In addition, the phase within the theta cycle (i.e., whether you are at the peak or the trough of the wave) is important for memory function. When information is presented to the animal at the peak of the theta cycle, learning is enhanced. Although most research in the rat has focused on the hippocampal theta rhythm, theta oscillations have also been found in numerous other brain regions in both rats and other animals, suggesting that they play a very general role in the way brain networks operate.
Human Intracranial Recordings Although one can crudely measure the human brain's electrical signals by recording from the scalp, the ability to actually observe and measure oscillations generated in local regions of the brain requires recordings taken from electrodes implanted in the brain (i.e., invasive EEG, or iEEG recording). Such iEEG recordings are often clinically required in the surgical treatment of severe medication-resistant epilepsy (i.e., seizure disorders that are not controlled by standard drug therapies). The location of electrodes is selected for each patient on the basis of clinical needs. This often includes electrodes in the mesial temporal lobe, including the hippocampus and entorhinal cortex along with cortical surface electrodes. At UTSW (UT Southwestern Medical Center), the use of stereo encephalography provides the unique opportunity to record from multiple deep brain locations and examine properties of electrical activity suggesting communication between these areas.
iEEG recordings taken during treatment for intractable epilepsy (as described above) have already been used to greatly enhance our knowledge of the physiology of human cognition. First, iEEG recordings sample from much smaller brain volumes than scalp-recorded EEG or magnetoencephalographic (MEG) signals, are not subject to distortions produced by the human skull, and are relatively impervious to movement artifacts because of their high signal-to-noise ratio. iEEG recordings also offer far better temporal resolution than functional magnetic resonance imaging (fMRI).
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
This study's planned enrollment of 200 is above the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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)
Intracranial electroencephalography (iEEG) power in the theta band
Time-frequency analyses of iEEG data during decision making
Time frame: 5 years
iEEG high-gamma activity
Time-frequency analyses of iEEG data during decision making
Time frame: 5 years
iEEG theta-gamma phase-amplitude coupling
Time-frequency analyses of iEEG data during decision making
Time frame: 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.
Time frame: 5 years
Behavioral accuracy (neuromodulation)
Measure task accuracy observed in response to small pulses delivered by electrical stimulation during cognitive testing.
Time frame: 5 years
Reaction times (neuromodulation)
Measure reaction times on task observed in response to small pulses delivered by electrical stimulation during cognitive testing.
Time frame: 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.
Time frame: 5 years
Plan to share: No
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Started Jul 2026 (actual). Primary completion is estimated for Dec 2031, 65 months after the start.
Of 90 non-industry interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21. This study's planned 65 months is above that.
Counting every sponsor, half of 102 studies reached it within 34 months; a quarter within 21 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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