RecruitingNCT00001778

Evaluation of Patients With HAM/TSP

Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)


Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Enrollment

750 participants

Start Date

Apr 6, 1998

Study Type

OBSERVATIONAL

Conditions

Summary

Objective: Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by monitoring clinical progression of patients longitudinally. Additionally, we will attempt to define the virological and immunological changes of HAM/TSP. Study Population: Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate. Design and Outcome Measures: A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with seroindeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes may be obtained from participants. Lumbar punctures may be performed on all participants. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response, and the genetic makeup. ...


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating people infected with HTLV-1 — a virus that can affect the nervous system — to understand the disease HAM/TSP (a progressive spinal cord condition caused by the virus). **You may be eligible if...** - You have tested positive for HTLV-1 infection - You have an unclear or borderline HTLV blood test result - You are a family member or close contact of someone with HTLV-1 who may have been exposed - You are a healthy volunteer - You are 18 years of age or older **You may NOT be eligible if...** - You are under 18 years of age - You have a medical, social, or psychiatric condition that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT00001778