Clinical trial Recruiting at 1 site Observational Ages 18 to 120

Evaluating patients with HTLV-I infection and tropical spastic paraparesis

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

Run by National Institutes of Health Clinical Center (CC) · NCT00001778 · Data updated 2026-11-12

This study is trying to understand how HTLV-I infection affects people with tropical spastic paraparesis over time by tracking their symptoms and health changes.

Quick facts

Study typeObservational
Ages18 Years to 120 Years
SexAll
Enrollment750 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedApril 6, 1998
Registry record updatedNovember 9, 2026
Trial IDNCT00001778 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with HAM/TSP, asymptomatic seropositive individuals, and those with indeterminate HTLV-1 serology.

Probably not a fit

Patients under the age of 18 or those with medical conditions that may affect their safety or compliance with the study will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the natural history of human T-lymphotropic virus type-I-associated myelopathy/tropical spastic paraparesis (HAM/TSP) by conducting longitudinal assessments of patients diagnosed with the condition. It will monitor clinical progression and analyze virological and immunological changes over time. Eligible participants include those with confirmed HTLV-I infection, seroindeterminate individuals, and healthy volunteers. The study will involve periodic testing and evaluations to gather comprehensive data on the disease's progression.

Why it matters

Potential benefit: If successful, this study could enhance understanding of HAM/TSP and lead to improved management strategies for affected patients.

How similar studies have gone: While there is existing literature on HTLV-1, this study's longitudinal approach to understanding HAM/TSP is relatively novel and may provide new insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:

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.

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.
* Patients/healthy volunteers under the age of 18 are excluded.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Steven Jacobson, Ph.D. — National Institute of Neurological Disorders and Stroke (NINDS)
  • Study coordinator: Christopher Y Itoh, M.D.
  • Email: christopher.itoh@nih.gov
  • Phone: (301) 496-3825

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.