NCT00034723

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2004

First QC Date

May 1, 2002

Last Update Submit

March 3, 2008

Conditions

Tropical Spastic Paraparesis

Keywords

DTIMRSIMTRNAWNFiber-TractNormal ControlHealthy VolunteerHVHTLV-1 Associated MyelopathyTropical Spastic ParaparesisHAM/TSP

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • McDonald WI, Compston A, Edan G, Goodkin D, Hartung HP, Lublin FD, McFarland HF, Paty DW, Polman CH, Reingold SC, Sandberg-Wollheim M, Sibley W, Thompson A, van den Noort S, Weinshenker BY, Wolinsky JS. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001 Jul;50(1):121-7. doi: 10.1002/ana.1032.

    PMID: 11456302BACKGROUND

  • Frank JA, McFarland HF. How to participate in a multiple sclerosis clinical trial. Neuroimaging Clin N Am. 2000 Nov;10(4):817-30 ,x.

    PMID: 11359727BACKGROUND

  • Gessain A, Gout O. Chronic myelopathy associated with human T-lymphotropic virus type I (HTLV-I). Ann Intern Med. 1992 Dec 1;117(11):933-46. doi: 10.7326/0003-4819-117-11-933.

    PMID: 1443956BACKGROUND

MeSH Terms

Conditions

Paraparesis, Tropical Spastic

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsHTLV-I InfectionsDeltaretrovirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 1, 2002

First Posted

May 2, 2002

Study Start

April 1, 2002

Study Completion

March 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-03

Locations

US(1)