Completed

Assessment of Cardiac and Paroxysmal Abnormalities in Rett Syndrome Patients

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What is being collected

Data Collection

Who is being recruted

Intellectual Disability+13

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

+ Nervous System Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: August 1995
See protocol details

Summary

Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00004773
Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

95 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Intellectual DisabilityCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsHeredodegenerative Disorders, Nervous SystemDisease AttributesGenetic Diseases, InbornX-Linked Intellectual DisabilityGenetic Diseases, X-LinkedMental DisordersNeurologic ManifestationsRett SyndromeRare Diseases

Criteria

Classical Rett syndrome meeting Rett Syndrome Diagnostic Work Group criteria Age-matched girls without neurologic or cardiac problems entered as controls

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers