Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life
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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 |
- 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 |
Patients with Multiple Sclerosis, no geographic limitations
Inclusion Criteria:
- Diagnosis of Multiple Sclerosis
Exclusion Criteria:
- Excludes CIS (clinically isolated syndrome)
Contacts and Locations| Contact: Diana L Driscoll, O.D. | 817.416.0333 | DrDiana@Prettyill.com |
| Contact: Richard A Driscoll, O.D. | 817.431.4900 | RDriscoll@TotalEyeCare.net |
| 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. | |
| 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 Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013