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Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome



Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome

For Condition: Rett Syndrome
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , Baylor College of Medicine
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Observational, Screening
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: - Classical Rett syndrome meeting Rett Syndrome Diagnostic Work Group criteria - Age-matched girls without neurologic or cardiac problems entered as controls
Total Enrollment: 95

Location and Contact Information:

Overall Study Official:
DanielGlaze,  Study Chair,  Baylor College of Medicine


Additional Information:
Study ID Numbers:  199/11798;  BCM-H2465
Study Start Date: August 1995
Record last reviewed: January 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004773

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