Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children

NCT01521130 | Completed Phase 1 DMC

• 1 other identifier: R01NS065840-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This project examines how seizures, and abnormal brain activity, affect language skill in children with Benign Childhood Epilepsy with Centro-Temporal Spikes (BECTS). BECTS is a common type of childhood epilepsy, and while BECTS patients stop having seizures by their late teenage years, many studies have shown that these children have language problems that may lead to academic and social difficulties. Using standardized language testing, monitoring of brain activity, and MRI brain imaging, this project aims to determine what particular combination of BECTS symptoms put children most at risk for language problems and whether treatment with anti-epileptic medications may be helpful.

Conditions

Benign Childhood Epilepsy With Centro-Temporal Spikes

Keywords

Benign Childhood Epilepsy With Centrotemporal Spikes; Benign Rolandic Epilepsy

Outcome Measures

Primary Outcomes (1)

• Number of Centrotemporal Spikes per minute on EEG

  52 weeks

Secondary Outcomes (2)

• Composite Score on CELF-4 Core Subtests (Language)

  52 Weeks

• fMRI Lateralization indices for three language tasks

  52 Weeks

Study Arms (3)

Healthy Control

NO INTERVENTION

Healthy Control

BECTS, no medication

NO INTERVENTION

BECTS, no medication

Levetiracetam Higher dose

EXPERIMENTAL

Levetiracetam Higher dose

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

Medication doses are defined on a mg/kg basis. Dosage form, frequency and titration schedule is based on accepted clinical practice.

Also known as: Keppra

Levetiracetam Higher dose

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis: Child has newly diagnosed BECTS according to International League Against Epilepsy (ILAE) criteria (including normal EEG background for age, at least 1 partial onset seizure, and unilateral or bilateral central/mid-temporal sharp waves with a positive horizontal dipole).
• Age: The child's age is between 5 years, 0 months and 13 years, 11 months at study entry.
• Language: The child must be a monolingual native speaker of English.
• Handedness : The child must be right-handed.
• Females: females of child bearing potential must agree to an acceptable and non-systemic form of birth control (including abstinence).
• Intelligence: The child must have clinician-judged normal intelligence.
• Academic History: The child must have an academic history of a regular education program (i.e., not in a special education class or program) without repeating grades.
• Parent/Guardians:
• The patient's parent/guardian must be able to keep an accurate seizure record.
• Informed consent from the child's parent or legal guardian.
• Parents (guardians) must be able and willing to comply with instructions and study procedures.
• Assent: Assent from the child if age 11 years or older.
• Demographic characteristics: Children will be between 7 and \< 14 years old at the time of enrollment. Children of both sexes and all race/ethnicities will be enrolled.

You may not qualify if:

• Clinical Contraindications
• Children with diagnosis of Benign Occipital Epilepsy (BOE - normal EEG background, and unilateral or bilateral occipital sharp waves activated by eye closure).
• Children with history of primary generalized seizures (absence, myoclonic, drop).
• Children with mixed seizure disorder (e.g., Lennox-Gastaut Syndrome).
• Children sensory seizures only (i.e., auras).
• Children with diagnoses of pervasive developmental disorders (e.g., autism/autism spectrum disorders).
• Children with progressive neurological disease (e.g., degenerative, progressive neoplasm).
• Children with major medical disease (e.g., IDDM, depression, suicide attempt. cancer, renal failure).
• Children with a history of neonatal seizures.
• Pregnancy: Children who are pregnant will not be eligible for enrollment.
• Prior Therapy
• Children previously or currently treated with an AED for any reason (other than non chronic benzodiazepine, e.g., ED treatment).
• Children taking any psychoactive agent other than psychostimulants for ADD/ADHD.
• Children taking a psychostimulant for ADD/ADHD and not on a stable dose for at least 2 weeks at time of study enrollment.
• MRI

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

• Tenney JR, Glauser T, Altaye M, Szaflarski JP, Spencer C, Morita D, Vannest J. Longitudinal stability of interictal spikes in benign epilepsy with centrotemporal spikes. Epilepsia. 2016 May;57(5):805-11. doi: 10.1111/epi.13367. Epub 2016 Mar 25.

  PMID: 27012680 RESULT

• Vannest J, Tenney JR, Altaye M, Byars AW, Spencer C, Maloney TC, Szaflarski JP, Morita D, Glauser TA. Impact of frequency and lateralization of interictal discharges on neuropsychological and fine motor status in children with benign epilepsy with centrotemporal spikes. Epilepsia. 2016 Aug;57(8):e161-7. doi: 10.1111/epi.13445. Epub 2016 Jun 28.

  PMID: 27350662 RESULT

MeSH Terms

Conditions

Epilepsy, Rolandic

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jennifer Vannest, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

US (1)