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Observational Study of HTLV-I Infection and Tropical Spastic Paraparesis

This is an observational study for people with HTLV-I infection or Tropical Spastic Paraparesis (HAM/TSP), a rare nerve disorder. Researchers are not testing a new treatment, but rather observing the natural course of the disease. They want to understand how HAM/TSP progresses over time and to identify changes in the virus and the body's immune system. You may be eligible if you have tested positive for HTLV infection, have a family member with HTLV, or are a healthy individual. The study aims to characterize your clinical features, imaging results, immune markers, and viral studies at each visit. The study is currently unclear on its status and plans to enroll about 750 participants.

Study design
This is an observational study with no specified phase, aiming to enroll 750 participants. It is designed to monitor the natural history of HTLV infection and HAM/TSP.
What's involved
Participants will have their clinical features, imaging studies, immunological markers, and viral studies measured at each study visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed longitudinally, with primary endpoints measured at each study visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00001778

Evaluation of Patients With HAM/TSP

Recruiting
Not specifiedAges 18+Observational
National Institute of Neurological Disorders and Stroke (NINDS)
~750 participants
Updated 2026-08-27 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.
Measured over each study visit

Conditions

HTLV-I Infection
Tropical Spastic Paraparesis

Explore related trials

HTLV-1 Associated Myelopathy/Tropical Spastic ParaparesisHTLV-1 InfectionHTLV-1 Infection

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Steven Jacobson, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)

Who to contact

Daniel S Reich, M.D.
[email protected]
(301) 496-1801
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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

    To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.