Comparison Between Clinical and MRI Multiple Sclerosis Activity and Expression of Human Endogenous Retrovirus Type W and Herpesvirus

NCT02489877 | Unknown DMC

• 1 other identifier: Fcmscsp-HERV
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multiple sclerosis is the most common autoimmune inflammatory disease of the central nervous system. It is known that your etiology has genetic and environmental causes. Several viruses have been implicated as triggers as well as perpetrators of this disease. Several studies make the correlation between Endogenous Retrovirus Type W (HERV-W) and the family Herpesviridae and activity in the pathogenesis of multiple sclerosis. The most important characteristics of the virus implicated in the pathogenesis of the disease is the fact that they have latency periods of exacerbation and they have, as their main biological environment, the central nervous system. The HERV-W, Epstein-Barr virus (EBV), cytomegalovirus, herpes virus type 6 and type 7 herpesvirus members are the most studied as causes of multiple sclerosis. It was found that these viruses are closely involved in the pathogenesis of MS, but it is believed that aren't the only responsible for its beginning. It is likely that this disease presents numerous triggers and more studies are needed to determine these interactions. In addition, a study comparing the activity of multiple sclerosis with the presence of these viruses was never realized.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; HERV-W virus; Herpesviridae family

Outcome Measures

Primary Outcomes (1)

• Composite: Degree of disease activity

  The degree of disease activity will be a composite of clinical and imaging measures. Clinical measures will be analyzed by annualized rate of relapses and EDSS-scale increase. The imaging measures will be analyzed by increase cranial lesions on MRI. This date will be correlated with quantitative assessment of HERV-W and viruses of the Herpesviridae family.

  1 year

Study Arms (3)

Multiple Sclerosis

Patients diagnosed with Multiple Sclerosis

without Multiple Sclerosis

Healthy individuals without neurological disease associated

with other neurological diseases

Patients diagnosed with the following diseases: Lateral Amniotrofic Sclerosis, Headache , Parkinson's disease, Dementia and Epilepsy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study group will be composed by patients diagnosed with multiple sclerosis and with other neurological diseases ( Lateral AmniotroficSclerosis, Headache, Parkinson's, Dementia and Epilepsy). And the control group will be composed by blood donors who are considered healthy control.

You may qualify if:

• patients diagnosed with multiple sclerosis;
• patients diagnosed with other neurological diseases (Lateral Amniotrofic Sclerosis , Headache, Parkinson's, Dementia and Epilepsy);
• healthy control: blood donors;

You may not qualify if:

• patients diagnosed with other non-neurological diseases;

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead
• University of Sao Paulo: collaborator

Related Publications (26)

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MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: expert - medical residence

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 3, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: July 3, 2015

Record last verified: 2015-07