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 range
5 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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