Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT01377805
Status:
WITHDRAWN
Last Update Posted:
2024-02-14
First Post:
2011-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2011-06-19', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Head Circumference in Multiple Sclerosis patients (retrospectively)', 'timeFrame': "Retrospectively, between patient's birth to 15 months of age", 'description': 'Measurement of head circumferences, weight and length of children (retrospectively), will be compared to "normals" as established by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), 2008.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis hydrocephalus'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '7712624', 'type': 'BACKGROUND', 'citation': "O'Brien T, Paine M, Matotek K, Byrne E. Apparent hydrocephalus and chronic multiple sclerosis: a report of two cases. Clin Exp Neurol. 1993;30:137-43."}, {'pmid': '18208891', 'type': 'BACKGROUND', 'citation': 'Vilisaar J, Harikrishnan S, Suri M, Constantinescu CS. Ehlers-Danlos syndrome and multiple sclerosis: a possible association. Mult Scler. 2008 May;14(4):567-70. doi: 10.1177/1352458507083187. Epub 2008 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis patients commonly develop generalized ventricular dilation with or without cerebral atrophy over time. Case studies in the literature have noted some multiple sclerosis patients develop the typical "normal pressure hydrocephalus" triad of dementia, gait disturbance and incontinence which were responsive to shunts.\n\nMany patients with connective tissue disorders (Ehlers-Danlos Syndrome) develop Multiple Sclerosis and studies indicate that in the Multiple Sclerosis population, there exists over 10% more Ehlers-Danlos patients than in the normal population.\n\nBecause studies are indicating a form of external communicating hydrocephalus in the Ehlers-Danlos population, the author hypothesizes the same type of hydrocephalus may occur in the Multiple Sclerosis population.\n\nTo evaluate this hypothesis, investigators will retroactively evaluate the head circumference of Multiple Sclerosis patients between birth and 15 months (before the skull sutures have closed).', 'detailedDescription': 'Multiple sclerosis patients commonly develop generalized ventricular dilation with or without cerebral atrophy over time. Case studies in the literature have noted some multiple sclerosis patients develop the typical "normal pressure hydrocephalus" triad of dementia, gait disturbance and incontinence which were responsive to shunts.\n\nMany patients with connective tissue disorders (Ehlers-Danlos Syndrome) develop Multiple Sclerosis and studies indicate that in the Multiple Sclerosis population, there exists over 10% more Ehlers-Danlos patients than in the normal population.\n\nBecause studies are indicating a form of external communicating hydrocephalus in the Ehlers-Danlos population, the author hypothesizes the same type of hydrocephalus may occur in the Multiple Sclerosis population.\n\nTo evaluate this hypothesis, investigators will retroactively evaluate the head circumference of Multiple Sclerosis patients between birth and 15 months (before the skull sutures have closed).\n\nHigh pressure on the brain (even if subtle) could be evidence of congenital CCSVI (cerebrospinal venous insufficiency), increased cerebrospinal fluid (CSF) production, the poor drainage of cerebral spinal fluid, or a combination of all. Retrospective examination of skull expansion is a necessary step to ascertain these possibilities, allowing for early treatment and the hope of avoidance of the neurological symptoms, and often disabling effects. It is the author\'s belief that "Benign External Hydrocephalus" is not a benign condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Multiple Sclerosis, no geographic limitations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Multiple Sclerosis\n\nExclusion Criteria:\n\n* Excludes CIS (clinically isolated syndrome)'}, 'identificationModule': {'nctId': 'NCT01377805', 'briefTitle': 'Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life', 'organization': {'class': 'OTHER', 'fullName': 'Genetic Disease Investigators'}, 'officialTitle': 'Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life -- a Retrospective Analysis', 'orgStudyIdInfo': {'id': '61/3529'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Sclerosis patients', 'description': 'Multiple sclerosis patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76034', 'city': 'Colleyville', 'state': 'Texas', 'country': 'United States', 'facility': 'POTS Care', 'geoPoint': {'lat': 32.88096, 'lon': -97.15501}}], 'overallOfficials': [{'name': 'Diana L Driscoll, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Genetic Disease Investigators'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genetic Disease Investigators', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}