Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT05758220
Status:
UNKNOWN
Last Update Posted:
2023-03-14
First Post:
2023-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MRI Brain (Volumetry, fMRI & MRS) in Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-12', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Structural MRI brain volumetry', 'timeFrame': 'Baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'resting functional MRI & MR spectroscopy', 'timeFrame': 'Baseline', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI brain in ASD'], 'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '11427137', 'type': 'RESULT', 'citation': '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': '11039681', 'type': 'RESULT', 'citation': 'Eliez S, Reiss AL. MRI neuroimaging of childhood psychiatric disorders: a selective review. J Child Psychol Psychiatry. 2000 Sep;41(6):679-94.'}, {'pmid': '21068835', 'type': 'RESULT', '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 Nov 11;468(7321):263-9. doi: 10.1038/nature09582.'}]}, 'descriptionModule': {'briefSummary': 'To reach a feasible method for diagnosing Autism Spectrum Disorder (ASD) outcome measures:\n\n1. Primary (main):\n\n 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.\n\n Detection of other concurrent lesions, e.g. tuberous sclerosis\n2. Secondary (subsidiary):\n\nlevels 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', 'detailedDescription': "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.\n\nMagnetic-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.\n\nFunctional 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\n\nInvestigating brain network activity during the resting state has emerged as a new method that eliminates the caveats of task-based fMRI studies\n\nThe 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.\n\nMRS'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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with Autism Spectrum Disorder', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children clinically diagnosed with Autism Spectrum Disorder.\n* Males and Females.\n* Children with an IQ of more than 70%\n\nExclusion Criteria:\n\n* Severe forms of ASD.\n* Children with IQ less than 70%.\n* Children with claustrophobia.'}, 'identificationModule': {'nctId': 'NCT05758220', 'briefTitle': 'MRI Brain (Volumetry, fMRI & MRS) in Autism', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Magnetic Resonance Imaging of the Brain in Children With Autism Spectrum Disorder (ASD)', 'orgStudyIdInfo': {'id': 'MRI Brain in Autism'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'Structural MRI volumetry, resting functional MRI \\& MR spectroscopy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Ab Sayed, MSc', 'role': 'CONTACT', 'email': 'dr.abudeif@gmail.com', 'phone': '00201008253457'}, {'name': 'Mohamed ab AbdelTawab, MD', 'role': 'CONTACT', 'email': 'dr.m.tawab@gmail.com', 'phone': '01009319309'}], 'overallOfficials': [{'name': 'Mohamed ab AbdelTawab, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radio-Diagnosis & Interventional Radiology Specialist', 'investigatorFullName': 'Mohamed AbuDeif Sayed', 'investigatorAffiliation': 'Assiut University'}}}}