Vascular Fundus Changes in Patients With High Probability of Chronic Cerebrospinal Venous Insufficiency (CCSVI)

NCT ID: NCT01356134

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-04-30

Brief Summary

The investigators propose that evidence of chronic cerebrospinal venous insufficiency (CCSVI) may be evident in the vasculature of the fundus. The investigators will be examining fundi of multiple sclerosis patients and Ehlers-Danlos patients to see if evidence of CCSVI can be found in these patients having high risk for CCSVI. The investigators will read the fundus photos, compared to age-matched normals in a "blind" fashion.

Detailed Description

Chronic Cerebrospinal Venous Insufficiency (CCSVI) has been proposed as the cause of numerous neurodegenerative diseases of the brain. CCSVI is the result of poor drainage of blood (and cerebral spinal fluid to some degree) from weakened or stenosed veins usually located in the cervical area (most notably the internal jugular veins). Although current focus and treatment of CCSVI is on multiple sclerosis, CCSVI has also been implicated as a potential cause of Alzheimer's disease and Parkinson's Disease. Additionally, patients with Ehlers-Danlos Syndrome (EDS) -- a disorder of connective tissue -- are more prone to developing multiple sclerosis than the general population. Many EDS patients are known to have weakened and abnormal blood vessels and 40 - 70% of EDS patients develop autonomic dysfunction in addition to numerous other symptoms found in patients with CCSVI. In the small subset of EDS and multiple sclerosis patients seen at Total Eye Care, the investigators have noticed a vascular irregularity (using the optomap® and examining the results under high magnification) which offers credence to the theory of CCSVI. Such objective data has been elusive, excepting for fMRI, ultrasound (to a limited degree) and venous angioplasty results. Current treatment of CCSVI involves the ballooning and sometimes stenting, of abnormally stenosed veins. The treatment of CCSVI offers hope to many patients suffering from multiple sclerosis. Although CCSVI research is in its infancy, many doctors believe that CCSVI is a significant portion of the solution to patients with neurodegenerative diseases of the brain. Because CCSVI is a vascular disorder, the investigators hypothesize that the investigators are able to screen candidates for CCSVI via the optomap®.

Conditions

Ehlers-Danlos Syndrome; Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Multiple sclerosis and or Ehlers-Danlos

Patients with suspected or confirmed cases of Ehlers Danlos Syndrome and or Multiple Sclerosis

No interventions assigned to this group

Age matched normals

Age matched normals

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• age matched normals
• patients with diagnosed or suspected Ehlers-Danlos Syndrome and/or diagnosed or suspected Multiple Sclerosis ("CIS")

Exclusion Criteria

• diabetics and patients unable to sit in position for testing are excluded

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Optos, PLC

INDUSTRY

Sponsor Role: collaborator

Genetic Disease Investigators

OTHER

Sponsor Role: lead

Responsible Party

Diana Driscoll, O.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana L Driscoll, O.D.

Role: STUDY_DIRECTOR

Genetic Disease Investigators

Richard A Driscoll, O.D.

Role: PRINCIPAL_INVESTIGATOR

Genetic Disease Investigators

Clair A Francomano, M.D.

Role: STUDY_CHAIR

Harvey Institute for Human Genetics

Locations

Total Eye Care

Colleyville, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18208891 (View on PubMed)

Singh AV, Zamboni P. Anomalous venous blood flow and iron deposition in multiple sclerosis. J Cereb Blood Flow Metab. 2009 Dec;29(12):1867-78. doi: 10.1038/jcbfm.2009.180. Epub 2009 Sep 2.

Reference Type: BACKGROUND

PMID: 19724286 (View on PubMed)

Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Tacconi G, Dall'Ara S, Bartolomei I, Salvi F. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):392-9. doi: 10.1136/jnnp.2008.157164. Epub 2008 Dec 5.

Reference Type: BACKGROUND

PMID: 19060024 (View on PubMed)

Other Identifiers

61/3527

Identifier Type: -

Identifier Source: org_study_id