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Evaluation of Patients With HAM/TSP

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people over time to learn how HAM/TSP, a rare nerve disorder linked to the HTLV-1 virus, changes. It also studies the virus and the body's defenses against infection. Adults with HAM/TSP, positive or unclear HTLV test results, possible exposure to HTLV, or no health problems may take part.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must fit at least one of these groups: have positive HTLV tests; have unclear HTLV test results; have a family member or partner with HTLV and possible exposure to the virus; or be a healthy volunteer.
  • You must be willing to take part in the study's tests and procedures.

Who can't join

  • You are under age 18.
  • You are unwilling or unable to take part in the study's tests and procedures.
  • The study doctor believes a health, mental health, or social issue could make participation unsafe or keep you from following study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MD