Actively Recruiting
Evaluation of Patients With HAM/TSP
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-07
750
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Patients With HAM/TSP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Willingness to participate in the protocol evaluations and procedures.
You will not qualify if you...
- Unwillingness or inability to participate in the protocol evaluations and procedures
- Presence of any medical, social, or psychiatric conditions that may affect patient safety or compliance with the protocol
- Patients or healthy volunteers under the age of 18
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
Daniel S Reich, M.D.
CONTACT
S
Steven Jacobson, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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