Study on the Brain Network of Angelman Syndrome

Angelman Syndrome Clinical Trial

Official title:

Study on the Brain Network of Angelman Syndrome Based on Multi-modal Brain Image and Neural-EEG Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358823
• Other study ID #: 2016YFC0904400
• Status: Completed
• Start date: May 20, 2017
• Est. completion date: May 20, 2019

Study information

• Verified date: April 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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）.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Angelman Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. Neuroima — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angelman syndrome databas; Brain Network of Angelman syndrome	Analysis of geneal situation of Chinese Angelman syndrome including phenotype ,genotype, brain image ,EEG data, living quality ,comorbidy evolulation(n=200); Study on the Brain Network of Angelman Syndrome Based on Multi-modal Brain Image and Neural-EEG Data	0-18 years old