Evaluation of Patients With HAM/TSP

Descriptive Information
Brief Title ^†	Evaluation of Patients With HAM/TSP
Official Title ^†	Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
Brief 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 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.
Detailed Description	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.
Study Phase	N/A
Study Type ^†	Observational
Study Design ^†	N/A
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HTLV-I Infection Tropical Spastic Paraparesis
Intervention ^†
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†
Estimated Enrollment ^†	300
Start Date ^†	December 1997
Completion Date
Primary Completion Date
Eligibility Criteria ^†	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.
Gender	Both
Ages	18 Years - N/A
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts ^††	Steven Jacobson, Ph.D., (301) 496-0519, jacobsons@mail.nih.gov , ,
Location Countries ^†	United States,
Administrative Information
NCT ID ^†	NCT00001778
Organization ID	980047
Secondary IDs ^††	98-N-0047
Responsible Party	,
Study Sponsor ^†	National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators ^††
Investigators ^†	Principal Investigator: Steven Jacobson, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS)
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	October 2012
First Received Date ^†	November 3, 1999
Last Updated Date	November 8, 2012

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.