NCT05758220

Brief Summary

To reach a feasible method for diagnosing Autism Spectrum Disorder (ASD) outcome measures:

  1. 1.Primary (main):
  2. 2.Secondary (subsidiary):

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

February 24, 2023

Last Update Submit

March 12, 2023

Conditions

Autism Spectrum Disorder

Keywords

MRI brain in ASD

Outcome Measures

Primary Outcomes (1)

  • Structural MRI brain volumetry

    Measurement of various brain structures, including the total brain volume, the volumes of specific brain regions (such as the amygdala, hippocampus, and the cerebellum), and the thickness of the cortex.

    Baseline

Secondary Outcomes (1)

  • resting functional MRI & MR spectroscopy

    Baseline

Interventions

MRIDEVICE

Structural MRI volumetry, resting functional MRI \& MR spectroscopy

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with Autism Spectrum Disorder

You may qualify if:

  • Children clinically diagnosed with Autism Spectrum Disorder.
  • Males and Females.
  • Children with an IQ of more than 70%

You may not qualify if:

  • Severe forms of ASD.
  • Children with IQ less than 70%.
  • Children with claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Chakrabarti S, Fombonne E. Pervasive developmental disorders in preschool children. JAMA. 2001 Jun 27;285(24):3093-9. doi: 10.1001/jama.285.24.3093.

    PMID: 11427137RESULT

  • Eliez S, Reiss AL. MRI neuroimaging of childhood psychiatric disorders: a selective review. J Child Psychol Psychiatry. 2000 Sep;41(6):679-94.

    PMID: 11039681RESULT

  • Chao HT, Chen H, Samaco RC, Xue M, Chahrour M, Yoo J, Neul JL, Gong S, Lu HC, Heintz N, Ekker M, Rubenstein JL, Noebels JL, Rosenmund C, Zoghbi HY. Dysfunction in GABA signalling mediates autism-like stereotypies and Rett syndrome phenotypes. Nature. 2010 Nov 11;468(7321):263-9. doi: 10.1038/nature09582.

    PMID: 21068835RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mohamed ab AbdelTawab, MD

    Assiut University

    STUDY CHAIR

Central Study Contacts

Mohamed Ab Sayed, MSc

CONTACT

00201008253457dr.abudeif@gmail.com

Mohamed ab AbdelTawab, MD

CONTACT

01009319309dr.m.tawab@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radio-Diagnosis & Interventional Radiology Specialist

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

April 1, 2023

Primary Completion

April 30, 2025

Study Completion

May 30, 2025

Last Updated

March 14, 2023

Record last verified: 2023-03