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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Baylor College of Medicine |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004773 |
OBJECTIVES: I. Evaluate electrocardiographic parameters, including QT and PR intervals and QRS morphology/duration, across clinical stages in patients with Rett syndrome. II. Characterize abnormalities of cardiac conduction and repolarization. III. Assess arrhythmias, heart rate variability, and autonomic nervous system function in these patients using 24-hour Holter monitoring.
IV. Record events believed to represent seizures with video, electroencephalogram (EEG), and polygraph monitoring in patients who have more than 1 clinical seizure every 5 days. V. Characterize these events with respect to clinical manifestations, EEG correlates, and other physiologic data.
VI. Determine the frequency of seizures vs. events without electrographic correlates in these patients.
VII. Determine whether Rett syndrome patients have characteristic or unique types of seizures and/or an epileptic syndrome.
Condition |
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Rett Syndrome |
Study Type: | Observational |
Study Design: | Screening |
Estimated Enrollment: | 95 |
Study Start Date: | August 1995 |
Estimated Study Completion Date: | June 1997 |
PROTOCOL OUTLINE: Patients receive an electrocardiogram at baseline and every 6 months for 3 years. Clinical stage II patients undergo 24-hour Holter monitoring on the same schedule; age-matched controls are tested once. A group of patients with more than 1 seizure or possible seizure every 5 days undergo 5-day continuous electroencephalogram/polygraphic/video monitoring, with respiratory effort assessment, end tidal carbon dioxide and oxygen saturation levels, and a seizure log.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 199/11798, BCM-H2465 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004773 History of Changes |
Health Authority: | United States: Federal Government |
Rett syndrome neurologic and psychiatric disorders rare disease |
Developmental Disabilities Rare Diseases Neurodegenerative Diseases Mental Retardation Child Development Disorders, Pervasive Rett Syndrome Heredodegenerative Disorders, Nervous System |
Genetic Diseases, Inborn Mental Disorders Mental Disorders Diagnosed in Childhood Genetic Diseases, X-Linked Neurologic Manifestations Congenital Abnormalities Neurobehavioral Manifestations |
Disease Nervous System Diseases Neurodegenerative Diseases Mental Retardation Child Development Disorders, Pervasive Rett Syndrome Pathologic Processes Heredodegenerative Disorders, Nervous System |
Genetic Diseases, Inborn Mental Disorders Syndrome Mental Disorders Diagnosed in Childhood Genetic Diseases, X-Linked Neurologic Manifestations Mental Retardation, X-Linked Neurobehavioral Manifestations |