Tropical Spastic Paraparesis Clinical Trial
Official title:
MRI Investigation Of The CNS In HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP)
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Frank JA, McFarland HF. How to participate in a multiple sclerosis clinical trial. Neuroimaging Clin N Am. 2000 Nov;10(4):817-30 ,x. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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