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Not yet recruitingNCT05758220Updated Mar 14, 2023

MRI Brain (Volumetry, fMRI & MRS) in Autism

An observational study in Autism Spectrum Disorder, sponsored by Assiut University. Not yet recruiting. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
3 Years to 12 Years
Sex
All
01

Study 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

Read the detailed 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.

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Conditions studied

  • Autism Spectrum Disorder

Keywords

  • MRI brain in ASD
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In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's planned enrollment of 25 is below the median of 102 across 267 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children with Autism Spectrum Disorder

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe forms of ASD.
  • Children with IQ less than 70%.
  • Children with claustrophobia.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • DeviceMRI

    Structural MRI volumetry, resting functional MRI \& MR spectroscopy

06

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. 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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 11427137 ↗
  • Eliez S, Reiss AL. MRI neuroimaging of childhood psychiatric disorders: a selective review. J Child Psychol Psychiatry. 2000 Sep;41(6):679-94. PubMed 11039681 ↗
  • 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. PubMed 21068835 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2023, 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
NCT05758220
Lead sponsor
Assiut University
Responsible party
Mohamed AbuDeif Sayed (Radio-Diagnosis & Interventional Radiology Specialist, Assiut University) — Principal investigator
First posted
Mar 7, 2023
Start date
Apr 1, 2023 (estimated)
Primary completion
Apr 30, 2025 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Mar 14, 2023

Study contacts

Mohamed Ab Sayed, MSc
Contact
dr.abudeif@gmail.com
00201008253457
Mohamed ab AbdelTawab, MD
Contact
dr.m.tawab@gmail.com
01009319309
Mohamed ab AbdelTawab, MD
study chair · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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