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Understanding Brain Responses in Epilepsy Patients with Neuropace RNS System

This study aims to understand how the brain's prefrontal and medial temporal areas respond to complex thinking tasks in people with epilepsy. Researchers are using the NEUROPACE RNS SYSTEM, a device that helps reduce seizures, and observing patients in an Epilepsy Monitoring Unit (EMU) to study seizure activity. The goal is to learn more about how the brain adapts to new situations without prior practice. Success in this study will be measured by how accurately participants perform tasks and by observing the electrical activity of individual brain cells. The study is currently recruiting male and female patients aged 10 to 64 who are having electrodes placed in their brain for epilepsy characterization.

Study design
This is an interventional study with a planned enrollment of 205 participants. The study does not specify a phase.
What's involved
Participants will undergo placement of intracranial electrodes and be admitted to an Epilepsy Monitoring Unit (EMU) for observation. Behavioral performance and neural activity will be collected over 7-14 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured over 7-14 days for both behavioral performance and neural activity.

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NCT05283811

Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients

Recruiting
NAAges 10–64InterventionalHealth services
Baylor College of Medicine
~205 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:NEUROPACE RNS SYSTEMEMU

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Behavioral performance (Accuracy as fraction of correct responses)
Measured over 7-14 days of behavioral performance collection
+1 more outcome measured

Conditions

Epilepsy

Explore related trials

Seizure Disorder

Where it's being run

3 sites across 3 states
California1
Texas1
Utah1

Who to contact

Sameer Sheth, MD, PhD
[email protected]
713-798-5060
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Eligibility criteria

Inclusion

Eligible subjects include both male and female patients, between 10 years of age and 64 years of age, who undergo placement of intracranial electrodes for clinical characterization of epilepsy.

Exclusion

Grounds for exclusion would include inability to understand and follow instructions, or inability to concentrate sufficiently to achieve a high proportion of correct responses.

What this trial measures

  • Behavioral performance (Accuracy as fraction of correct responses)7-14 days of behavioral performance collection

    Patients will be asked to perform a few different novel, computerized tasks where the patients must respond to on-screen stimuli using button presses. Behavior will be assessed in terms of the accuracy of these responses.

  • Neurophysiological activity (single-neuron activity in spikes/second)7-14 days of neural activity collection

    While patients are performing each behavioral task, the investigators will measure neural activity from BlackRock using depth electrodes with the aim of isolating single-neuron activity (for patients in the EMU) and local-field potential activity (for patients in the RNS patients). Neurophysiological activity will be analyzed with the aim of understanding the neural representations underlying cognitive performance during the task.