Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05260502
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2022-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Relationship Between Brain Volume and Sensory Integration in Autistic and Attention Deficit Hyperactivity Disorder.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensory disintegration in neurodevelopmental disorders', 'timeFrame': '2 years', 'description': 'Estimate the prevalence of sensory disintegration problems among study groups and differentiate the pattern of sensory disintegration problems among study groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sensory disintegration'], 'conditions': ['Sensory Integration Dysfunction']}, 'referencesModule': {'references': [{'pmid': '24443636', 'type': 'BACKGROUND', 'citation': 'Gourley L, Wind C, Henninger EM, Chinitz S. Sensory Processing Difficulties, Behavioral Problems, and Parental Stress in a Clinical Population of Young Children. J Child Fam Stud. 2013 Oct 1;22(7):912-921. doi: 10.1007/s10826-012-9650-9.'}, {'pmid': '26157208', 'type': 'BACKGROUND', 'citation': 'Al-Heizan MO, AlAbdulwahab SS, Kachanathu SJ, Natho M. Sensory processing dysfunction among Saudi children with and without autism. J Phys Ther Sci. 2015 May;27(5):1313-6. doi: 10.1589/jpts.27.1313. Epub 2015 May 26.'}, {'pmid': '25374136', 'type': 'BACKGROUND', 'citation': 'Schaaf RC, Lane AE. Toward a Best-Practice Protocol for Assessment of Sensory Features in ASD. J Autism Dev Disord. 2015 May;45(5):1380-95. doi: 10.1007/s10803-014-2299-z.'}]}, 'descriptionModule': {'briefSummary': 'The relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study', 'detailedDescription': 'Detect pattern of sensory disintegration in autistic and attention deficit hyperactivity disorder children and adolescence. Also detect relationship between changes in brain and sensory disintegration in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Both males and females were included. Age ranges from 6- 18 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria .Diagnosis of Autism spectrum disorders /ADHD verified and confirmed on a clinical basis.\n\n. Willing of the parents or the caregivers to participate in the study.\n\nExclusion Criteria:\n\n.Children with intelligence quotient below 70. .Children with history or current substance use. .Children with medical or other neurological conditions. .Children with history of preterm labour (as brain volume lower than term delivery).\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05260502', 'briefTitle': 'The Relationship Between Brain Volume and Sensory Integration in Autistic and Attention Deficit Hyperactivity Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Relationship Between Brain Volume and Sensory Integration in Children and Adolescence With Attention Deficit Hyperactivity Disorder and Autistic Spectrum Disorder.', 'orgStudyIdInfo': {'id': 'Trbbvas'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autistic children', 'description': 'magnetic resonance imaging brain for autistic children'}, {'label': 'attention deficit hyperactivity disorder children', 'description': 'magnetic resonance imaging brain for attention deficit hyperactivity disorder children'}, {'label': 'Normal children', 'description': 'magnetic resonance imaging brain for Normal children'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amira Mohammed Moheb, assistant lecturer', 'role': 'CONTACT', 'email': 'amiramoheb1992@yahoo.com', 'phone': '01064093337'}, {'name': 'Alaa El-Dien Mohamed Darwish, professor', 'role': 'CONTACT', 'email': 'Assiutbird25@yahoo.com', 'phone': '01005279326'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Amira Moheb', 'investigatorAffiliation': 'Assiut University'}}}}