Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-27 @ 7:57 PM
Study NCT ID:
NCT05604092
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2022-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in RRMS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The relation of white matter lesion load, location and parameters of cognitive function measured by BICAMS', 'timeFrame': '6 months', 'description': 'correlation of BICAMS subtests scores to different parameters of white matter lesion load, distribution and load (volume and number of lesion) measurements (whole brain atrophy, grey matter and white matter lesion load) to identify best predictors of cognitive impairment'}, {'measure': 'The relation of white matter lesion load, location and Fatigue in patients with relapsing remitting multiple sclerosis', 'timeFrame': '6 months', 'description': 'correlation between fatigue severity, with white matter lesion load, and distribution in order to identify predictors of fatigue'}], 'secondaryOutcomes': [{'measure': 'the relation of white matter lesion load, location and atrophy parameters to physical disability in patients with relapsing remitting multiple sclerosis', 'timeFrame': '6 months', 'description': 'correlation of EDSS scores, with white matter lesion load and distribution'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'In relapsing remitting multiple sclerosis (RRMS) the relationship between cognitive impairment (CI), fatigue and physical disability with white matter lesion load (WM-LL), location among other volumetric measures using automated platforms is still unclear.', 'detailedDescription': 'Cognitive impairment (CI) and fatigue have been recognized as an important feature of MS, affecting up to 70% patients (1), evident since onset and increase in both prevalence and severity as the disease progresses (2). In fact, their effects on patients and even their caregivers are more pronounced than clinical disability, causing unemployment, treatment non-adherence, personality changes as well as several psychosocial dysfunctions (3-5). Therefore, beside evaluating the physical disability, it is essential for health professionals to objectively evaluate either the cognitive function or fatigue at both baseline and during routine follow up visits for early detection and management (6). Through the advances in MRI techniques and availability of a number of automated software, quantitative radiological assessments became more readily available and feasible in daily practice (7) allowing objective longitudinal monitoring of patients (8,9). Although burden and location of lesions in RRMS is thought to be associated with cognitive impairment (CI), fatigue and physical disability, some controversy results were obtained from previous studies. So, by conducting this study, we aimed at exploring the relationship between different parameters of lesion load and location with fatigue, cognitive and physical disability in RRMS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with relapsing remitting multiple sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* : adult patients of both sexes diagnosed with RRMS according to 2017 McDonald diagnostic criteria\n\nExclusion Criteria:\n\n* Patients with relapse or steroid administration in the past 30 days were excluded. Patients who have any medical conditions that may affect cognition, and those on psychoactive pharmacotherapy were also excluded.'}, 'identificationModule': {'nctId': 'NCT05604092', 'briefTitle': 'Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in RRMS', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'White Matter Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in Patients With Relapsing Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'lesion load and distribution'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VolBrain, a fully automated platform to generate the volumetric data (lesion count, volume and location as well as different atrophy measures)', 'type': 'DIAGNOSTIC_TEST', 'description': 'VolBrain, a fully automated platform that uses anonymized compressed NIFTI files to generate the volumetric data. Volbrain is increasingly recognized and compared to other volumetric tools. LesionBrain is a pipeline to automatically segment WM-L from T1 and FLAIR data. Number of lesions, absolute total lesion volume (in cubic cm), normalized lesion volume (percentage of total lesion volume to whole brain volume), lesion burden (percentage of total WM lesion volume to WM volume), and location (Periventricular, Juxtacortical, and Infratentorial) were obtained.'}, {'name': 'Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)', 'type': 'OTHER', 'description': 'It includes the Symbol Digit Modalities Test (SDMT) for evaluating the information processing speed, the California Verbal Learning Test (CVLT-II) for evaluating verbal learning and memory, and the Brief Visual Memory Test (BVMT) for evaluating visual learning and memory. Cut off values were calculated as 1.5 SD below mean according to a group of healthy individuals who are matched in age, sex and education as following: 22 for SDMT, 38 for CVLT, and 10 for BVMTR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11517', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Eman Khedr', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Eman M Khedr, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Eman M. Khedr', 'investigatorAffiliation': 'Assiut University'}}}}