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

Multiple Sclerosis Clinical Trial

Official title:

Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life -- a Retrospective Analysis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01377805
• Other study ID #: 61/3529
• Status: Withdrawn
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2015
• Source: Genetic Disease Investigators
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of Multiple Sclerosis

Exclusion Criteria:

• Excludes CIS (clinically isolated syndrome)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	POTS Care	Colleyville	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genetic Disease Investigators

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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