MRI Brain Studies in Patients With HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
Completed
Conditions studied: Tropical Spastic Paraparesis
In brief
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.
Key facts
- Study ID
- NCT00034723
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 40
- Starts
- 2002-04-01
- Expected to finish
- 2004-03-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- National Institute of Neurological Disorders and Stroke (NINDS) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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