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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Genetic Disease Investigators.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Genetic Disease Investigators
ClinicalTrials.gov Identifier:
NCT01377805
First received: June 19, 2011
Last updated: June 20, 2011
Last verified: June 2011
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life -- a Retrospective Analysis

Resource links provided by NLM:


Further study details as provided by Genetic Disease Investigators:

Primary Outcome Measures:
  • Measurement of Head Circumference in Multiple Sclerosis patients (retrospectively) [ Time Frame: Retrospectively, between patient's birth to 15 months of age ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 25
Study Start Date: June 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Multiple Sclerosis patients

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377805

Contacts
Contact: Diana L Driscoll, O.D. 817.416.0333 DrDiana@Prettyill.com
Contact: Richard A Driscoll, O.D. 817.431.4900 RDriscoll@TotalEyeCare.net

Locations
United States, Texas
Total Eye Care Recruiting
Colleyville, Texas, United States, 76034
Contact: Richard A Driscoll, O.D.    817-416-0333    RDriscoll@TotalEyeCare.net   
Contact: Diana L Driscoll, O.D.    817.416.0333    DrDiana@Prettyill.com   
Sub-Investigator: Richard A Driscoll, O.D.         
Principal Investigator: Diana L Driscoll, O.D.         
Sponsors and Collaborators
Genetic Disease Investigators
Investigators
Principal Investigator: Diana L Driscoll, O.D. Genetic Disease Investigators
Study Chair: Richard A Driscoll, O.D. Genetic Disease Investigators
  More Information

Additional Information:
Publications:
Responsible Party: Diana Driscoll, O.D., Study Director, Genetic Disease Investigators
ClinicalTrials.gov Identifier: NCT01377805     History of Changes
Other Study ID Numbers: 61/3529
Study First Received: June 19, 2011
Last Updated: June 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Genetic Disease Investigators:
Multiple Sclerosis hydrocephalus

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014