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Evaluation of Patients With HAM/TSP
This study is currently recruiting participants.
Verified November 2011 by National Institutes of Health Clinical Center (CC)

First Received on November 3, 1999.   Last Updated on December 22, 2011   History of Changes
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001778
  Purpose

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.


Condition
HTLV-I Infection
Tropical Spastic Paraparesis

Study Type: Observational
Official Title: Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency
MedlinePlus related topics: Bone Marrow Diseases Neurologic Diseases
U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 300
Study Start Date: December 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001778

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact            
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Gessain A, Barin F, Vernant JC, Gout O, Maurs L, Calender A, de The G. Antibodies to human T-lymphotropic virus type-I in patients with tropical spastic paraparesis. Lancet. 1985 Aug 24; 2(8452): 407-10.
Osame M, Matsumoto M, Usuku K, Izumo S, Ijichi N, Amitani H, Tara M, Igata A. Chronic progressive myelopathy associated with elevated antibodies to human T-lymphotropic virus type I and adult T-cell leukemialike cells. Ann Neurol. 1987 Feb; 21(2): 117-22.
Iwasaki Y. Pathology of chronic myelopathy associated with HTLV-I infection (HAM/TSP). J Neurol Sci. 1990 Apr; 96(1): 103-23.

ClinicalTrials.gov Identifier: NCT00001778     History of Changes
Other Study ID Numbers: 980047, 98-N-0047
Study First Received: November 3, 1999
Last Updated: December 22, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immune Response
Sero-Indeterminant
Transmission
Tropical Spastic Paraparesis
 Viral Load
HTLV-I
HAM/TSP

Additional relevant MeSH terms:
HTLV-I Infections
Paraparesis, Tropical Spastic
Paraparesis, Spastic
Paraparesis
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Paresis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012



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