Benign Childhood Epilepsy With Centro-Temporal Spikes Clinical Trial
— FIRSTOfficial title:
Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children
| Verified date | November 2017 |
| Source | Children's Hospital Medical Center, Cincinnati |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | July 2017 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 5 Years to 13 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital Medical Center, Cincinnati | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
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. — View Citation
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 centrot — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Centrotemporal Spikes per minute on EEG | 52 weeks | ||
| Secondary | Composite Score on CELF-4 Core Subtests (Language) | 52 Weeks | ||
| Secondary | fMRI Lateralization indices for three language tasks | 52 Weeks |