Evaluation of Patients With HAM/TSP
Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
2 other identifiers
observational
750
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 1998
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedMay 7, 2026
December 30, 2025
November 3, 1999
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.
To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.
each study visit
Secondary Outcomes (1)
Change in proviral load
each study visit
Study Arms (3)
healthy volunteers
At least 18 years old and have no history of any medical illness that may confound study results or make participation in this protocol impossible
individuals seropositive for HTLV
Positive HTLV-1 ELISA followed by a positive Western Blot
individuals with indeterminate HTLV sero-status
Positive HTLV ELISA but a Western Blot that only partially fulfills criteria
Eligibility Criteria
Individuals sero-positive for HTLV, individuals with indeterminate HTLV sero-status, and healthy volunteers are eligible to participate in this protocol. Some individuals sero-positive for HTLV may have associated diseases including but not limited to HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) and HTLV associated inflammatory myositis.
You may qualify if:
- Participants that meet one of the following criteria:
- Test positive for HTLV infection (positive HTLV-1 ELISA followed by a positive Western blot)
- Positive HTLV ELISA but a Western Blot that only partially fulfills the above criteria (seroindeterminate)
- Have a family member/significant other who is HTLV positive, and may have been exposed to the virus
- Healthy volunteer AND
- Willingness to participate in the protocol evaluations and procedures.
You may not qualify if:
- 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.
- Patients/healthy volunteers under the age of 18 are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (3)
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. doi: 10.1016/s0140-6736(85)92734-5.
PMID: 2863442BACKGROUNDOsame 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. doi: 10.1002/ana.410210203.
PMID: 2881513BACKGROUNDIwasaki Y. Pathology of chronic myelopathy associated with HTLV-I infection (HAM/TSP). J Neurol Sci. 1990 Apr;96(1):103-23. doi: 10.1016/0022-510x(90)90060-z.
PMID: 2351985BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Jacobson, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
April 6, 1998
Last Updated
May 7, 2026
Record last verified: 2025-12-30