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NCT03077308 · ClinicalTrials.gov registry record
Rare Diseases Clinical Research Network: Neurophysiological Correlates
A clinical trial of Rett Syndrome, Preserved Speech Variant and Mecp2 Duplication Syndrome, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 185
- Enrollment target
- 5
- Study locations
NCT03077308: Completed study of Rett Syndrome, Preserved Speech Variant and Mecp2 Duplication Syndrome, sponsored by University of Alabama at Birmingham.
NCT03077308 is a study of Rett Syndrome, Preserved Speech Variant and Mecp2 Duplication Syndrome that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 185 participants. The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03077308, a study of Rett Syndrome, Preserved Speech Variant and Mecp2 Duplication Syndrome, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 185 participants
- Enrollment target
- 5
- Study locations
Study Summary
The overall purpose of this project is to advance understanding of the neurophysiological features of Rett syndrome (RTT), MECP2 Duplication (MECP2 Dup) and RTT-related disorders (CDKL5, FOXG1) to gain insight into disease pathogenesis, with an emphasis on identifying biomarkers of disease evolution and severity. This specific study is intertwined to the core study Natural History of Rett Syndrome and Related Disorders (RTT5211), which characterizes range of clinical involvement and genotype-phenotype correlations and will provide phenotypical data for determining the clinical relevance of the neurophysiologic parameters; study subjects here are co- and primarily enrolled in RTT5211. The proposed studies will serve as basis of future translational investigations, including further refinement of biomarkers, development of outcome measures, and clinical trials per se.
Primary Outcome
EEG will be filtered between 0.5 and 400Hz. The EEG will be segmented around each stimulus presentation. 200msec prior to 1000msec post each stimulus will be collected and averaged for each trial for each electrode. The electrodes with highest averaged N1 waveforms, predicted to be posterior temporal (T5/P3/T3) electrodes, will be used for subsequent analysis. The averaged waveforms will be analyzed for latency to N1 and P1 peak frm which the auditory event related potentials will be the main pa
Conditions Studied
Interventions
- PROCEDURE Auditory and Visual Event-related Potentials and EEG
Study Locations (5)
Colorado
- University of Colorado Denver - Denver
Massachusetts
- Boston Children's Hospital - Boston
Ohio
- Cincinnati Children's Hospital - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Tennessee
- Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2017-01-02 |
| Est. Completion | 2021-07-31 |
What the finished NCT03077308 record still lists
NCT03077308 is an observational study that tracks outcomes without assigning an intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap.
The record links to 3 conditions, with Rett Syndrome, Preserved Speech Variant appearing as the primary indexed condition, and to 1 intervention - of which Auditory and Visual Event-related Potentials and EEG is the first listed.
NCT03077308 lists 5 locations in 5 states (Colorado, Massachusetts, Ohio).
Frequently Asked Questions
What is clinical trial NCT03077308 about?
NCT03077308 is a clinical study titled "Rare Diseases Clinical Research Network: Neurophysiological Correlates". The overall purpose of this project is to advance understanding of the neurophysiological features of Rett syndrome (RTT), MECP2 Duplication (MECP2 Dup) and RTT-related disorders (CDKL5, FOXG1) to gain insight into disease pathogenesis, with an emphasis on identifying biomarkers of disease evolution...
What is the current status of trial NCT03077308?
This trial is currently completed. The enrollment target is 185 participants. The study started on 2017-01-02. Estimated completion is 2021-07-31.
What conditions does trial NCT03077308 study?
This clinical trial studies the following conditions: Rett Syndrome, Preserved Speech Variant, Mecp2 Duplication Syndrome, Rett-related Disorders.
What interventions are being tested in trial NCT03077308?
The interventions under investigation include: Auditory and Visual Event-related Potentials and EEG (PROCEDURE).
Who is sponsoring clinical trial NCT03077308?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03077308 being conducted?
This trial has 5 study locations across Colorado, Massachusetts, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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