An observational study in Rett Syndrome, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed. Open to female participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational
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.
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.
98 studies on the registry are indexed under Rett Syndrome; 20 are open to participants now.
This study's enrollment of 95 is close to the median of 98 across 32 observational studies indexed under Rett Syndrome.
Browse Rett Syndrome studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
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This study is completed, as verified in Jan 1997. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)