ClinicalTrials.gg
RecruitingNCT07350551Updated Oct 6, 2026

Pediatric Epilepsy

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

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Updated Oct 6, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
3 Years to 25 Years
Sex
All
01

Study 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.

Read the detailed description

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).

02

Conditions studied

  • 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
03

In context

Drug Resistant Epilepsy

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
3 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study 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.

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

Interventions

  • BehavioralCedrus 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)

06

What researchers measure

Primary outcomes

  1. Intracranial electroencephalography (iEEG) power in the theta band

    Time-frequency analyses of iEEG data during decision making

    Time frame: 5 years

  2. iEEG high-gamma activity

    Time-frequency analyses of iEEG data during decision making

    Time frame: 5 years

  3. iEEG theta-gamma phase-amplitude coupling

    Time-frequency analyses of iEEG data during decision making

    Time frame: 5 years

  4. 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

  5. Behavioral accuracy (neuromodulation)

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

    Time frame: 5 years

  6. 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

  7. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Dec 16, 2025
First posted
Jan 20, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Dec 2031
CompletionEst.
Dec 2032
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 6, 2026
Sites
Children's Medical Center Dallas is now Recruiting
Oct 6, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Children's Medical Center Dallas · Dallas, United StatesContact added Z•••@utsouthwestern.edu · •••3884Contact added t•••@utsouthwestern.edu · •••1355Contact added (no phone or email listed)Contact added (no phone or email listed)
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Not yet recruiting→Recruiting
    Children's Medical Center Dallas is now Recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Children's Medical Center Dallas · Dallas, United StatesContact added Z•••@utsouthwestern.edu · •••3884Contact added t•••@utsouthwestern.edu · •••1355Contact added (no phone or email listed)Contact added (no phone or email listed)
    + 1 other change: date precision

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 ↗

10

Registry details

Key details

Study ID
NCT07350551
Responsible party
Angela Price (Clinical Associate Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Jan 20, 2026
Start date
Jul 1, 2026
Primary completion
Dec 2031 (estimated)
Completion
Dec 2032 (estimated)
Last update
Oct 6, 2026

Study contacts

Tashinga Mupambo
Contact
Tashinga.Mupambo@UTSouthwestern.edu
214-645-1355
Zhongzheng Fu
Contact
zhongzheng.fu@utsouthwestern.edu
214-648-3884
Angela V Price, M.D.
principal investigator · UT Southwestern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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