Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004773
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1997-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Evaluate electrocardiographic parameters including QT and PR intervals and QRS morphologyduration 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 andor an epileptic 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 andor an epileptic syndrome
Detailed Description:
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 electroencephalogrampolygraphicvideo monitoring with respiratory effort assessment end tidal carbon dioxide and oxygen saturation levels and a seizure log
A group of patients with more than 1 seizure or possible seizure every 5 days undergo 5-day continuous electroencephalogrampolygraphicvideo monitoring with respiratory effort assessment end tidal carbon dioxide and oxygen saturation levels and a seizure log
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCM-H2465 | None | None | None |