Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT03594357
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2018-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Functions in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive function', 'timeFrame': 'baseline', 'description': 'The Brief Repeatable Battery of Neuropsychological Tests will be used. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) consists of the selective reminding, 10/36 spatial recall, symbol digit modalities, paced auditory serial addition (PASAT) and word list generation tests.'}], 'secondaryOutcomes': [{'measure': 'Balance', 'timeFrame': 'baseline', 'description': 'The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural sway and sensory interaction. The participants will be asked to stand on both feet for 30 seconds under altered sensory conditions. The four conditions are as follows: 1. Eyes open-firm surface, 2. Eyes closed-firm surface; 3. Eyes open-foam surface, 4. Eyes closed-foam surface. Each test was repeated 3 times and the overall score was recorded.'}, {'measure': 'Functional exercise capacity.', 'timeFrame': 'baseline', 'description': 'The Six-Minute Walking Test (6-MWT) will be performed to determine the functional exercise capacity. The heart rate, blood pressure and fatigue severity of the participants are recorded before and after the test. The heart rate is assessed by a heart rate monitor and fatigue severity is assessed by the Modified Borg Scale. The participants are asked to walk as far as possible for 6 minutes in a 30-meter corridor. Finally, the walking distance will be recorded in meters.'}, {'measure': 'Fatigue', 'timeFrame': 'baseline', 'description': 'Fatigue impact scale will be used to assess fatigue. There are 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160. It is composed of three subscales that describe how fatigue impacts upon cognitive (10 items), physical (10 items) and psychosocial functioning (10 items). Cognitive functioning concerns concentration, memory, thinking and organization of thoughts. Physical functioning reflects motivation, effort, stamina and coordination. Psychosocial functioning describes the impact of fatigue upon isolation, emotions, workload and coping.A higher score indicates a higher fatigue impact.'}, {'measure': 'Mood', 'timeFrame': 'baseline', 'description': "Beck's Depression Inventory will be used to assess mood. The 21-item self-administered survey is scored on a scale of 0-3 in a list of four statements arranged in increasing severity about a particular symptom of depression. The highest possible total for the whole test would be sixty-three. A higher score indicates a higher depression."}, {'measure': 'Sleep Quality', 'timeFrame': 'baseline', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of "5" or greater is indicative of poor sleep quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Balance', 'Cognition', 'Functional exercise capacity', 'Fatigue', 'Sleep quality'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '2027484', 'type': 'BACKGROUND', 'citation': 'Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.'}, {'type': 'BACKGROUND', 'citation': 'Rao SM, Grafman J, DiGuilio D, et al. Memory dysfunction in multiple sclerosis: its relation toworking memory, semantic encoding and implicit learning.Neuropsychology 1993; 7:364-374'}, {'pmid': '16643953', 'type': 'BACKGROUND', 'citation': 'Amato MP, Zipoli V, Portaccio E. Multiple sclerosis-related cognitive changes: a review of cross-sectional and longitudinal studies. J Neurol Sci. 2006 Jun 15;245(1-2):41-6. doi: 10.1016/j.jns.2005.08.019. Epub 2006 Apr 27.'}, {'pmid': '16042232', 'type': 'BACKGROUND', 'citation': 'Lynch SG, Parmenter BA, Denney DR. The association between cognitive impairment and physical disability in multiple sclerosis. Mult Scler. 2005 Aug;11(4):469-76. doi: 10.1191/1352458505ms1182oa.'}, {'pmid': '25009224', 'type': 'BACKGROUND', 'citation': 'Sandroff BM, Pilutti LA, Benedict RH, Motl RW. Association between physical fitness and cognitive function in multiple sclerosis: does disability status matter? Neurorehabil Neural Repair. 2015 Mar-Apr;29(3):214-23. doi: 10.1177/1545968314541331. Epub 2014 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their cognitive function. Long-term memory is one of the most frequently affected functions in MS patients. Many factors play a role in the deterioration of cognitive functions because of many symptoms of MS.\n\nThe aim of this study is to investigate the relationship of cognitive function with physical factors such as balance, functional exercise capacity and personal factors such as fatigue level, mood, sleep quality in patients with MS.', 'detailedDescription': 'Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The cognitive function, balance, functional exercise capacity, fatigue, mood, sleep quality will be evaluated once.\n\nInvestigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p\\<0,05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'MS patients who apply to the Neurological Rehabilitation Unit of Gazi University Faculty of Health Sciences will be invited to this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who 18-65 years of age\n* MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.\n\nExclusion Criteria:\n\n* Participants who have orthopedic, vision, hearing, or perception problems'}, 'identificationModule': {'nctId': 'NCT03594357', 'briefTitle': 'Cognitive Functions in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Relationship of Cognitive Functions to Physical and Personal Factors in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '437'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple sclerosis', 'description': 'MS patients (EDSS: 0-5,5)'}, {'label': 'Control', 'description': 'Healthy individuals without chronic disease'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Cagla Ozkul', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'research assistant', 'investigatorFullName': 'Cagla Ozkul', 'investigatorAffiliation': 'Gazi University'}}}}