MRI Brain Studies in Patients With HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

Brief Title

MRI Brain Studies in Patients With HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

Official Title

MRI Investigation Of The CNS In HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP)

Brief Summary

      This study will use three different magnetic resonance imaging (MRI) techniques to study
      HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/STP)-a disease of slowly
      progressive weakness in the legs. It is not known how the HTLV-1 virus causes this disease,
      but it is thought that as the body's immune system tries to destroy the virus, parts of the
      nervous system-primarily the spinal cord-are damaged.

      Patients 18 years of age and older with HAM/TSP and healthy normal volunteers may be eligible
      for this study.

      Participants will undergo diffusion tensor MRI, MR-spectroscopy, and magnetization transfer
      imaging to look at different compositional, architectural, and microscopic properties of the
      brain. All of these techniques are similar to conventional MRI, and like the conventional
      method they use a strong magnetic field and radio waves to measure structural and chemical
      changes in brain tissue. Each of the three scans will be done on separate days, each lasting
      about 1 hour. For the procedures, the patient or volunteer lies on a stretcher in a narrow
      metal cylinder (the scanner) and is asked to remain still for 15 to 30 minutes at a time. A
      special lightweight coil may be placed on the head to enhance the brain images. The subject
      can communicate with the person doing the scan at all times.
    

Detailed Description

      Magnetic Resonance Imaging (MRI) has become an important tool in the diagnosis of
      inflammatory CNS diseases such as Multiple Sclerosis (MS) and HTLV-1 Associated
      Myelopathy/Tropical Spastic Paraparesis (HAM-TSP). It is widely used as a marker for disease
      activity and progression. However, conventional MRI methods are only suitable to study gross
      anatomical features, such as size and shape of a particular area of the brain; questions
      regarding intrinsic microstructure and morphologic specificity cannot be addressed. But
      axonal damage or structural abnormalities even in normal appearing brain tissue may play an
      important role in the development of irreversible disability. Magnetization Transfer Imaging,
      Magnetic Resonance Spectroscopy and Diffusion Tensor MRI are imaging techniques described to
      be capable of the detection of such changes. Spectroscopy can detect molecular components in
      tissue, whereas the Magnetization Transfer Ratio (MTR) allows the measurement of
      water-macromolecule interactions. Diffusion Tensor MRI (DT-MRI) is an imaging modality that
      combines features of in vivo anatomical MRI and histopathology: it is an in vivo MRI method
      that provides information about tissue composition, microstructure, organization and
      architecture. This is possible because water diffusion properties in tissues, as measured by
      DT-MRI, are affected by tissue constituents, such as macromolecules, membranes, organelles,
      as well as by tissue microstructure, architecture and organization. A study comprising
      Magnetization Transfer-, Spectroscopy- and DT-MRI furnishes important information that cannot
      be obtained using conventional MRI methods.
    


Study Type

Observational




Condition

Tropical Spastic Paraparesis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

40

Start Date

April 2002

Completion Date

March 2004


Eligibility Criteria

        INCLUSION CRITERIA:

        Patients:

        A. Established Diagnosis of HAM/TSP as defined by Osame, Igata, and Matsumoto and
        subsequently confirmed by Gessain and Gout and the WHO.

        B. Age 18 or older

        C. An initial cohort of 5 HAM/TSP patients with established disease with EDSS levels of 6.0
        or greater and duration of disease of 2 years or more will be investigated. If MRI
        abnormalities can be demonstrated, the group will be expanded to 20. Of this 20, at least 5
        patients have been identified that will be HLA A201.

        Healthy Controls:

        A. No history of disease of the nervous system or autoimmune disease

        B. Age 18 or older

        C. Subjects shall be sex- and age-matched to our patients

        EXCLUSION CRITERIA:

        A subject will be excluded if he/she has a contraindication to MRI scanning such as the
        following: Aneurysm clip; Implanted neural stimulator; Implanted cardiac pacemaker or
        autodefibrillator; Cochlear implant; Ocular foreign body or implant (e.g. metal savings,
        retinal clips); breast implants; or Insulin pumps. Subjects will be excluded if they have
        claustrophobia. A pregnancy test will be administered to women of childbearing age.
        Pregnant women will be excluded from the studies.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00034723

Organization ID

020180

Secondary IDs

02-N-0180


Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)


Study Sponsor

, , 


Verification Date

March 2004