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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05758220
Other study ID # MRI Brain in Autism
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date May 30, 2025

Study information

Verified date March 2023
Source Assiut University
Contact Mohamed Ab Sayed, MSc
Phone 00201008253457
Email dr.abudeif@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To reach a feasible method for diagnosing Autism Spectrum Disorder (ASD) outcome measures: 1. Primary (main): Measurement of various brain structures, including the total brain volume, the volumes of specific brain regions (such as the amygdala, hippocampus, and cerebellum), and the thickness of the cortex. Detection of other concurrent lesions, e.g. tuberous sclerosis 2. Secondary (subsidiary): levels of various neurotransmitters, such as glutamate and GABA, and other metabolites, such as N-acetyl aspartate (NAA), in specific regions of the brain Assessing neural activity and connectivity in the brain in the resting state


Description:

Autism spectrum disorder (ASD) is a heterogeneous disorder (or collection of related disorders) of multifactorial etiology, and with a great range in severity of symptoms. ASD affects approximately 1 in 166 children and is four times more prevalent in boys than in girls. Core features of individuals with autism include 1) impairment in reciprocal social interactions; 2) verbal and nonverbal communication deficits; 3) repetitive and ritualized behaviors; and 4) a narrow range of interests. Approximately 30% of individuals with ASD manifest some degree of mental retardation. Magnetic-resonance (MR) examination allows researchers and clinicians to noninvasively examine brain anatomy in vivo. Structural MR examination is widely used to investigate brain morphology because of its high contrast sensitivity and spatial resolution, and because it entails no radiation exposure; the last feature is particularly important for children and adolescents. Functional magnetic resonance imaging (fMRI) has proven to be a useful tool to investigate aberrant neurobiological function in ASDs because of its excellent contrast properties, spatial resolution, and temporal resolution. fMRI uses specialized pulse sequences to localize metabolic correlates of neural activity linked to relevant neurocognitive processes Investigating brain network activity during the resting state has emerged as a new method that eliminates the caveats of task-based fMRI studies The fMRI signal is measured during the resting state and the data is analyzed based on a connectivity approach between subdivisions. To date, brain network activity during the resting state has been investigated in subjects with ASD and typical development in numerous studies. Overall, intrinsic connectivity between subdivisions of the brain is altered in patients with ASD compared to controls. MRS's finding is that gamma oscillations are reduced in ASD patients. Gamma oscillations are generated by GABAergic neurons and are involved in sensory binding and higher cognitive functions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date May 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria: - Children clinically diagnosed with Autism Spectrum Disorder. - Males and Females. - Children with an IQ of more than 70% Exclusion Criteria: - Severe forms of ASD. - Children with IQ less than 70%. - Children with claustrophobia.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MRI
Structural MRI volumetry, resting functional MRI & MR spectroscopy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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. — View Citation

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 — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 resting functional MRI & MR spectroscopy levels of various neurotransmitters, such as glutamate and GABA, and other metabolites, such as N-acetyl aspartate (NAA), in specific regions of the brain Assessing neural activity and connectivity in the brain in the resting state Baseline
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