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Evaluation of Patients With HAM/TSP

National Institute of Neurological Disorders and Stroke (NINDS) · NCT00001778

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–120 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
750
US sites recruiting
1
Study start
April 6, 1998
Record last updated
September 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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: HTLV-I Infection; Tropical Spastic Paraparesis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

Study contacts (from the official record)

  • Daniel S Reich, M.D. · (301) 496-1801 · reichds@ninds.nih.gov
  • Steven Jacobson, Ph.D. · (301) 496-0519 · jacobsons@ninds.nih.gov
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Evaluation of Patients With HAM/TSP (NCT00001778) | Bored Studies