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CompletedNCT03358823Updated Apr 26, 2021

Study on the Brain Network of Angelman Syndrome

An observational study in Angelman Syndrome, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-26.

Sponsored by Fudan University · Observational

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Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
Up to 18 Years
Sex
All
01

Study summary

The aims of study on Angelman syndrome:

  1. Establish the Angelman syndrome database
  2. Explore the brain Network of Angelman Syndrome Based on Multi-modal Brain Image and Neural-EEG Data
Read the detailed description
  1. The participants recruitment: from Chinese Angelman Syndrome Patients group (Angelhome : angelman225@126.com) and Children's Hospital of Fudan University.
  2. Fistly all participants had clinically and molecularly confirmed as Angelman syndrome . All participants should entry the online questionnaries and carified by telephone or on site . All the information will be recorded in the Angelman syndrome database. Investigators will analyze and summarize the relationship of phenotype and genotype(n=200).
  3. Participants who assigned the informed consent and will undergo the brain MRI inspection and Neural-EEG recording in the Children's Hospital of Fudan University. The healthy age- and sex-matched control participants will enrolled in the same hospital. The Investigators will explore the brain morphology and electrophysiological alterations and for Angelman syndrome (AS) children among the different genotypes（n=200）.
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Conditions studied

  • Angelman Syndrome

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Keywords

  • AS database
  • MRI
  • EEG
03

In context

Angelman Syndrome

52 studies on the registry are indexed under Angelman Syndrome; 16 are open to participants now.

This study's enrollment of 150 is above the median of 120 across 21 observational studies indexed under Angelman Syndrome.

Browse Angelman Syndrome studies →

Lead sponsor

Fudan University is the lead sponsor of 1,316 studies on the registry; 644 are open to participants now.

Browse Fudan University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The patients of Angelman syndrome meet the clinical and genetic diagnosis criteria

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical and molecular diagnosis of Angelman syndrome.
  • Agreed and completed the MRI scan and EEG-recording by using oral chloral hydrate.

Exclusion criteria

Exclusion Criteria:

  • Reject MRI scan and EEG-recording by using oral chloral hydrate or unable to complete the scan.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Angelman syndrome

    Cases were children with the diagnosis meet the all 4 major criteria developmental delay, speech impairment, movement or balance disorder, and behavioral characteristics, as well as the presence of 3 of 6 minor criteria, including postnatal deceleration of head growth, seizures, abnormal EEG, sleep disturbance, attraction to or fascination with water, and drooling (summary by Tan et al., 2011). all patients meet the 4 known genetic mechanisms can cause Angelman syndrome (AS).,including maternal deletions involving chromosome 15q11.2-q13;paternal uniparental disomy of 15q11.2-q13;imprinting defectsand mutations in the gene encoding the ubiquitin-protein ligase E3A gene (UBE3A; 601623)

06

What researchers measure

Primary outcomes

  1. Angelman syndrome databas; Brain Network of Angelman syndrome

    1. Analysis of geneal situation of Chinese Angelman syndrome including phenotype ,genotype, brain image ,EEG data, living quality ,comorbidy evolulation(n=200) 2. Study on the Brain Network of Angelman Syndrome Based on Multi-modal Brain Image and Neural-EEG Data

    Time frame: 0-18 years old

07

Study locations

1 site
  • Children's Hospital of Fudan University
    Shanghai, Shanghai 200232, China
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References and documents

Publications

  • Aghakhanyan G, Bonanni P, Randazzo G, Nappi S, Tessarotto F, De Martin L, Frijia F, De Marchi D, De Masi F, Kuppers B, Lombardo F, Caramella D, Montanaro D. From Cortical and Subcortical Grey Matter Abnormalities to Neurobehavioral Phenotype of Angelman Syndrome: A Voxel-Based Morphometry Study. PLoS One. 2016 Sep 14;11(9):e0162817. doi: 10.1371/journal.pone.0162817. eCollection 2016. PubMed 27626634 ↗
  • Tiwari VN, Jeong JW, Wilson BJ, Behen ME, Chugani HT, Sundaram SK. Relationship between aberrant brain connectivity and clinical features in Angelman Syndrome: a new method using tract based spatial statistics of DTI color-coded orientation maps. Neuroimage. 2012 Jan 2;59(1):349-55. doi: 10.1016/j.neuroimage.2011.07.067. Epub 2011 Jul 30. PubMed 21827860 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in May 2019, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2017
First posted
Dec 2, 2017
StartActual
May 20, 2017
Primary completionActual
May 20, 2019
CompletionActual
May 20, 2019
Last update
Apr 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03358823
Lead sponsor
Fudan University
Responsible party
Yi Wang (Vice Prsident Chlidren's Hospital of Fudan University, Fudan University) — Principal investigator
First posted
Dec 2, 2017
Start date
May 20, 2017
Primary completion
May 20, 2019
Completion
May 20, 2019
Last update
Apr 26, 2021

Study contacts

Yi Wang, Dr.
principal investigator · Children's Hospital of Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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