Study Stopped
No participants
Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life
1 other identifier
observational
N/A
1 country
1
Brief Summary
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. Many 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. Because 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. To 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 19, 2011
CompletedFirst Posted
Study publicly available on registry
June 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFebruary 14, 2024
April 1, 2015
5 months
June 19, 2011
February 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of Head Circumference in Multiple Sclerosis patients (retrospectively)
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.
Retrospectively, between patient's birth to 15 months of age
Study Arms (1)
Multiple Sclerosis patients
Multiple sclerosis patients
Eligibility Criteria
Patients with Multiple Sclerosis, no geographic limitations
You may qualify if:
- Diagnosis of Multiple Sclerosis
You may not qualify if:
- Excludes CIS (clinically isolated syndrome)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
POTS Care
Colleyville, Texas, 76034, United States
Related Publications (2)
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: 7712624BACKGROUNDVilisaar 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.
PMID: 18208891BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana L Driscoll, O.D.
Genetic Disease Investigators
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2011
First Posted
June 21, 2011
Study Start
June 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
February 14, 2024
Record last verified: 2015-04