Health TrialsbyHealthPanel

Pediatric Epilepsy

ConditionEpilepsy Intractable
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-25
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

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

    Behavioral

    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)

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Interventional Arm (Cognitive testing)Experimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Source ClinicalTrials.gov
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