NCT01377805

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 14, 2024

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

June 19, 2011

Last Update Submit

February 13, 2024

Conditions

Keywords

Multiple Sclerosis hydrocephalus

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 7712624BACKGROUND
  • 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.

    PMID: 18208891BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Diana L Driscoll, O.D.

    Genetic Disease Investigators

    PRINCIPAL INVESTIGATOR
0

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

Locations