Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children (FIRST)
Benign Childhood Epilepsy With Centro-Temporal Spikes
About this trial
This is an interventional treatment trial for Benign Childhood Epilepsy With Centro-Temporal Spikes focused on measuring Benign Childhood Epilepsy With Centrotemporal Spikes, Benign Rolandic Epilepsy
Eligibility Criteria
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.
Sites / Locations
- Cincinnati Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
No Intervention
Experimental
Healthy Control
BECTS, no medication
Levetiracetam Higher dose
Healthy Control
BECTS, no medication
Levetiracetam Higher dose