Status:
COMPLETED
Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Benign Childhood Epilepsy With Centro-Temporal Spikes
Eligibility:
All Genders
5-13 years
Phase:
PHASE1
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 childho...
Detailed Description
Benign Childhood Epilepsy with Centro-Temporal Spikes (BECTS), an extremely common type of childhood epilepsy, is traditionally assumed to have a benign course, but recent studies have shown that cogn...
Eligibility Criteria
Inclusion
- Inclusion Criteria for BECTS participants
- 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.
- Exclusion Criteria for BECTS participants
- 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
- • Standard MRI exclusion criteria, e.g. orthodontic braces, cochlear implant or other metallic implants which obscure or interfere with the MRI.
- Special Education: Children with a special education placement based on ability or behavior.
- Informed Consent: Inability or unwillingness of child or legal guardian/representative to give written informed consent.
- Child not fluent in English.
- Inclusion Criteria for Healthy Controls
- 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.
- Parents/Guardians:
- 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 5 and \< 14 years old at the time of enrollment. Children of both sexes will be enrolled and no child will be excluded on the basis of race/ethnicity.
- Exclusion Criteria for Healthy Controls
- Clinical Contraindications
- Children with a diagnosis of a chronic neurological disorder.
- 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, 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 and MRI/EEG Abnormality
- • Standard MRI exclusion criteria, e.g. orthodontic braces, cochlear implant or other metallic implants which obscure or interfere with the MRI.
- Special Education: Children with a special education placement based on ability or behavior.
- Informed Consent: Inability or unwillingness of child or legal guardian/representative to give written informed consent.
- Child not fluent in English.
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01521130
Start Date
January 1 2012
End Date
July 1 2017
Last Update
November 14 2017
Active Locations (1)
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1
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229