Interventions for Pediatric Epilepsy

ZF
TM
Overseen ByTashinga Mupambo
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding brain function in learning, memory, decision-making, and self-control. The goal is to improve treatments for learning and memory issues. Participants will complete various cognitive tasks, which may include incentives, varying difficulty levels, and changing instructions. Ideal candidates are those already in the Epilepsy Monitoring Unit and scheduled to have depth intracranial electrodes placed by their doctor. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these cognitive tasks are safe for pediatric epilepsy patients?

Research has shown that cognitive tasks used to treat children with epilepsy are generally safe. One study found that computerized brain training programs can improve skills like time management and attention without causing major side effects. This indicates that children usually tolerate these tasks well.

The trial phase is labeled "Not Applicable," meaning the study focuses on understanding the treatment rather than seeking approval. While extensive safety data might be limited, cognitive tasks are generally considered safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about using cognitive tasks for pediatric epilepsy because this approach focuses on enhancing brain function through direct engagement rather than pharmacological intervention. Traditional treatments for epilepsy often involve medications like antiepileptics, which can come with side effects and don't always address cognitive deficits. This method leverages cognitive exercises that involve tasks with incentives and varying cognitive loads, aiming to improve decision-making and memory. By potentially strengthening neural pathways and improving cognitive performance, this approach offers a promising complement to existing treatments, potentially reducing reliance on medication.

What evidence suggests that cognitive tasks are effective for pediatric epilepsy?

Research has shown that activities challenging the brain can enhance thinking skills in children with epilepsy. A review of several studies found that brain exercises, known as neuropsychological interventions, boost mental abilities in people with epilepsy. About half of the children with epilepsy face difficulties with thinking and learning. Identifying these issues is crucial for planning better treatments. In this trial, all participants will undergo a series of cognitive tasks to evaluate the impact on learning, memory, and decision-making skills. Including brain exercises in treatment plans may help children with epilepsy improve these cognitive abilities.678910

Who Is on the Research Team?

AV

Angela V Price, M.D.

Principal Investigator

UT Southwestern

Are You a Good Fit for This Trial?

This trial is for pediatric patients with epilepsy who are being monitored and can undergo a pre-operative evaluation using special electrodes. They must be able to perform certain behavioral tasks, without cognitive, psychological limits or pain that would prevent participation.

Inclusion Criteria

Candidates admitted to the Epilepsy Monitoring Unit and 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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive task testing with iEEG recordings to measure brain activity during decision-making tasks

5 years
Regular visits for cognitive testing and iEEG recordings

Follow-up

Participants are monitored for safety and effectiveness after cognitive testing and iEEG recordings

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Tasks

Trial Overview

The study aims to understand how the brain manages learning, memory recall, decision-making, and self-control by using various devices like response pads and micro-electrodes during cognitive tasks in children with epilepsy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Interventional Arm (Cognitive testing)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40286280/

Cognitive screening informs referrals for neuropsychological ...

Objective: This study aimed to evaluate the effectiveness of current neuropsychology referral methods for children with epilepsy and develop ...

Screening of cognitive and behavioral comorbidity in ...

Out of 12 children who completed the study, 10 (10/12 or 83 %) proved to have cognitive or behavioral comorbidity of epilepsy, as was expressed by a positive ...

A Systematic Review and Meta-Analysis | Neuropsychology ...

This meta-analysis evaluated the effectiveness of neuropsychological interventions in enhancing cognition in patients with epilepsy.

Cognitive screening informs referrals for ...

This study aimed to evaluate the effectiveness of current neuropsychology referral methods for children with epilepsy and develop data-informed ...

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Cognitive deficits are seen in approximately half of patients with epilepsy, even at diagnosis [1]. A community-based cohort study.

Cognitive impairment in childhood onset epilepsy: up-to-date ...

Children with epilepsy are at an increased risk for a broad range of cognitive disturbances and have substantial intellectual disability hindering their ...

Cognitive outcome of pediatric epilepsy surgery across ...

85% of the patients were neuropsychologically impaired. Seizure control was excellent with 81% being seizure free one year after surgery.

Long-term neuropsychological trajectories in children with ...

Cognitive outcome of pediatric epilepsy surgery across ages and different types of surgeries: A monocentric 1-year follow-up study in 306 patients of school ...

Study Details | NCT07350551 | Pediatric Epilepsy

The purpose of the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, ...

Enhancing Executive Functions in Pediatric Epilepsy

This report presents a feasibility study investigating the effects of a computerized cognitive training program on enhancing executive functions.