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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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
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).
- Conditions
- Epilepsy Intractable
- 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 group | Role | What they receive |
|---|---|---|
| Interventional Arm (Cognitive testing) | Experimental | 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. 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.
Intracranial electroencephalography (iEEG) power in the theta band
Time-frequency analyses of iEEG data during decision making
Measured: 5 years
iEEG high-gamma activity
Time-frequency analyses of iEEG data during decision making
Measured: 5 years
iEEG theta-gamma phase-amplitude coupling
Time-frequency analyses of iEEG data during decision making
Measured: 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.
Measured: 5 years
Behavioral accuracy (neuromodulation)
Measure task accuracy observed in response to small pulses delivered by electrical stimulation during cognitive testing.
Measured: 5 years
Reaction times (neuromodulation)
Measure reaction times on task observed in response to small pulses delivered by electrical stimulation during cognitive testing.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jul 2026
- Primary completionDec 2031 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy IntractableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Price, University of Texas Southwestern Medical Center
- Investigators
- Angela V Price, M.D., Principal investigator, UT Southwestern
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Epilepsy
- ClinicalTrials.gov ID
- NCT07350551
- Acronym / sponsor ID
- STU20251324
- Conditions
- Epilepsy Intractable
- Keywords
- Epilepsy, Decision-making, Cognitive control, Memory, Depth Electrode, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm (Cognitive testing) | Experimental | Behavioral: Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulatorAll 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. |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulatorDevices 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) | Behavioural | Interventional Arm (Cognitive testing) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela V Price, M.D. principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
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.