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Epilepsy IntractableNCT07350551

Pediatric Epilepsy

A study testing Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator in people with Epilepsy Intractable, run by University of Texas Southwestern Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 25 years
Conditions the study is for
Epilepsy Intractable
What is being tested?
Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
1 Jul 2026to Dec 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Children's Medical Center Dallas

    Dallas, Texas, 75390

    Zhongzheng Fu, 214-648-3884, Zhongzheng.Fu@UTSouthwestern.edu

    Tashinga Mupambo, 214-645-1355, tashinga.mupambo@utsouthwestern.edu

    Recruiting

Other trials in United States

About this study

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).

Being tested
Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator
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
Medical subject headings
Drug Resistant Epilepsy, Epilepsy, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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)

Study groups in NCT07350551
Study groupRoleWhat they receive
Interventional Arm (Cognitive testing)ExperimentalAll 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.
Receives: Behavioral: Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Time-frequency analyses of iEEG data during decision making

    Measured: 5 years

  2. iEEG high-gamma activity

    Time-frequency analyses of iEEG data during decision making

    Measured: 5 years

  3. iEEG theta-gamma phase-amplitude coupling

    Time-frequency analyses of iEEG data during decision making

    Measured: 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.

    Measured: 5 years

  5. Behavioral accuracy (neuromodulation)

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

    Measured: 5 years

  6. Reaction times (neuromodulation)

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

    Measured: 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start1 Jul 2026
  3. Primary completionDec 2031 (estimated)
  4. Study completionDec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07350551
Sponsor's protocol ID
STU20251324
Status last verified
May 2026
First submitted
16 Dec 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator in people with Epilepsy Intractable, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tashinga Mupambo (214-645-1355, Tashinga.Mupambo@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial electroencephalography (iEEG) power in the theta band (time frame: 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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