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Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life

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ClinicalTrials.gov Identifier: NCT01377805
Recruitment Status : Withdrawn (No participants)
First Posted : June 21, 2011
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Genetic Disease Investigators

Study Description
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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).


Condition or disease
Multiple Sclerosis

Detailed Description:

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).

High 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.

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life -- a Retrospective Analysis
Study Start Date : June 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

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Groups and Cohorts
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Group/Cohort
Multiple Sclerosis patients
Multiple sclerosis patients


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of Head Circumference in Multiple Sclerosis patients (retrospectively) [ Time Frame: Retrospectively, between patient's birth to 15 months of age ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Multiple Sclerosis, no geographic limitations
Criteria

Inclusion Criteria:

  • Diagnosis of Multiple Sclerosis

Exclusion Criteria:

  • Excludes CIS (clinically isolated syndrome)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377805


Locations
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United States, Texas
Total Eye Care
Colleyville, Texas, United States, 76034
Sponsors and Collaborators
Genetic Disease Investigators
Investigators
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Principal Investigator: Diana L Driscoll, O.D. Genetic Disease Investigators
Study Chair: Richard A Driscoll, O.D. Genetic Disease Investigators
More Information
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Publications:

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Responsible Party: Genetic Disease Investigators
ClinicalTrials.gov Identifier: NCT01377805    
Other Study ID Numbers: 61/3529
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Keywords provided by Genetic Disease Investigators:
Multiple Sclerosis hydrocephalus
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases