Rett SyndromeNCT00004773
Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome
An observational study of Rett Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Rett Syndrome
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Aug 1995to Jun 1997
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
- Classical Rett syndrome meeting Rett Syndrome Diagnostic Work Group criteria
- Age-matched girls without neurologic or cardiac problems entered as controls
About this study
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.
Read more
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.
- 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.
Read the 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 electroencephalogram/polygraphic/video monitoring, with respiratory effort assessment, end tidal carbon dioxide and oxygen saturation levels, and a seizure log.
- Conditions
- Rett Syndrome
- Keywords
- Rett syndrome, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Rett Syndrome, Neurologic Manifestations, Mental Disorders, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startAug 1995
- Study completionJun 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rett SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 95 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Baylor College of Medicine
- Investigators
- Daniel G. Glaze, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004773
- Sponsor's protocol ID
- 199/11798
- Other IDs
- BCM-H2465
- Status last verified
- Jan 1997
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Glaze DG. Commentary: the challenge of Rett syndrome. Neuropediatrics. 1995 Apr;26(2):78-80. doi: 10.1055/s-2007-979728. No abstract available.
PubMed 7566458Glaze DG, Schultz RJ. Rett Syndrome: Meeting the Challenge of This Gender-Specific Neurodevelopmental Disorder. Medscape Womens Health. 1997 Jan;2(1):3.
PubMed 9746669Sekul EA, Moak JP, Schultz RJ, Glaze DG, Dunn JK, Percy AK. Electrocardiographic findings in Rett syndrome: an explanation for sudden death? J Pediatr. 1994 Jul;125(1):80-2. doi: 10.1016/s0022-3476(94)70128-8.
PubMed 8021793
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome
- ClinicalTrials.gov ID
- NCT00004773
- Acronym / sponsor ID
- 199/11798
- Conditions
- Rett Syndrome
- Keywords
- Rett syndrome, neurologic and psychiatric disorders, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Baylor College of Medicine
- Study start
- Aug 1995
- Study completion
- Jun 1997
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
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 electroencephalogram/polygraphic/video monitoring, with respiratory effort assessment, end tidal carbon dioxide and oxygen saturation levels, and a seizure log.
Study design
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 7566458Glaze DG. Commentary: the challenge of Rett syndrome. Neuropediatrics. 1995 Apr;26(2):78-80. doi: 10.1055/s-2007-979728. No abstract available.
- Background: PubMed 9746669Glaze DG, Schultz RJ. Rett Syndrome: Meeting the Challenge of This Gender-Specific Neurodevelopmental Disorder. Medscape Womens Health. 1997 Jan;2(1):3.
- Background: PubMed 8021793Sekul EA, Moak JP, Schultz RJ, Glaze DG, Dunn JK, Percy AK. Electrocardiographic findings in Rett syndrome: an explanation for sudden death? J Pediatr. 1994 Jul;125(1):80-2. doi: 10.1016/s0022-3476(94)70128-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel G. Glaze study chair
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Rett Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004773, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.