Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children
NCT ID: NCT01521130
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
108 participants
INTERVENTIONAL
2012-01-31
2017-07-31
Brief Summary
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Detailed Description
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This study will explore the interactions between CTS, seizures and neuropsychological outcomes using Functional MRI of language in order to decipher changes in neural circuitry that underlie language deficits found in children with BECTS. Using standardized neuropsychological testing and fMRI at the time of diagnosis, this study will first characterize the nature and incidence of language problems in children with BECTS, separating the effects of CTS and seizures. It is expected that children with BECTS will perform below normative standards on tests of language skill, accompanied by aberrations in the neural circuitry supporting language processing as tested with fMRI. These data will also make it possible to characterize which children with BECTS are most at risk for language problems, by taking into account contributing factors such as number of seizures, age of onset, and frequency and lateralization of CTS.
The proposed exploratory clinical trial will also provide key information needed to properly design and conduct a future double blind Phase III randomized clinical trial (RCT) children aimed at improving language outcome through elimination of CTS. Using an open-label dose-ranging design and 1-year follow up, we will determine the best dose of levetiracetam to control seizures, eliminate CTS and be well tolerated. We will also examine the extent of changes in language function and neural circuitry of language with 1-year follow-up neuropsychological testing and fMRI in LEV-treated and untreated BECTS compared to controls (which will document the natural history of neuropsychological function in untreated BECTS children and give additional information about the effect of LEV). The current study will provide crucial information for a future double blind RCT that will the compare the selected dose of levetiracetam to carbamazepine (the current standard of care) in BECTS. This would change clinical practice by demonstrating the need for AED treatment in BECTS to eliminate CTS, in turn improving long term language and cognitive outcome.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Healthy Control
Healthy Control
No interventions assigned to this group
BECTS, no medication
BECTS, no medication
No interventions assigned to this group
Levetiracetam Higher dose
Levetiracetam Higher dose
Levetiracetam
Medication doses are defined on a mg/kg basis. Dosage form, frequency and titration schedule is based on accepted clinical practice.
Interventions
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Levetiracetam
Medication doses are defined on a mg/kg basis. Dosage form, frequency and titration schedule is based on accepted clinical practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
* 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
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.
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
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.
5 Years
13 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Jennifer Vannest, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Countries
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References
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