Evaluation of Patients With HAM/TSP

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

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 with emphasis on defining its virological and immunological changes with respect to clinical progression.

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 serodeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes will be obtained from participants. Lumbar punctures may be performed on individuals with HAM/TSP. 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.

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 with emphasis on defining its virological and immunological changes with respect to clinical progression.

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 serodeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes will be obtained from participants. Lumbar punctures may be performed on individuals with HAM/TSP. 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.

N/A
Observational
N/A
  • HTLV-I Infection
  • Tropical Spastic Paraparesis
    * Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
    300
    December 1997
    • INCLUSION CRITERIA:

    • Positive HTLV-I EIA or Western blot positive for HTLV-I bands.

    • Willingness to participate in the protocol evaluations and procedures.

      EXCLUSION CRITERIA:

    • Unwillingness or inability to participate in the protocol evaluations and procedures.

    • The presence of any medical, social, or psychiatric conditions that in the opinion of the investigator may affect the safety of the patients or compliance with the protocol.

    • Children under the age of 18 are excluded.

    Both
    18 Years - N/A
    Accepts Healthy Volunteers
    • Steven Jacobson, Ph.D., (301) 496-0519, jacobsons@mail.nih.gov
    • , ,
    United States,
    NCT00001778
    980047
    98-N-0047
    ,
    National Institute of Neurological Disorders and Stroke (NINDS)
      Principal Investigator: Steven Jacobson, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS)
      National Institutes of Health Clinical Center (CC)
      August 2013
      November 3, 1999
      March 14, 2014
      Required WHO trial registration data element.
      †† WHO trial registration data element that is required only if it exists.