Evaluating patients with HTLV-I infection and tropical spastic paraparesis
Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
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 type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00001778 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with HAM/TSP, asymptomatic seropositive individuals, and those with indeterminate HTLV-1 serology.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- 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: Daniel S Reich, M.D.
- Email: reichds@ninds.nih.gov
- Phone: (301) 496-1801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.