Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children (NCT01521130) | Clinical Trial Compass
CompletedPhase 1
Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children
United States108 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range5 Years – 13 Years
SexALL
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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 Be…
What they're measuring
1
Number of Centrotemporal Spikes per minute on EEG
Timeframe: 52 weeks
Trial details
NCT IDNCT01521130
SponsorChildren's Hospital Medical Center, Cincinnati