Evaluation of Patients With HAM/TSP

Conditions

• HTLV-I Infection
• Tropical Spastic Paraparesis

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Accepted

Study Details

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. ...

Key Dates

Start date

Apr 6, 1998

Status verified

Jun 2026

Study Design

Enrollment

750 participants (estimated)

Arms

• Arm: healthy volunteers
  At least 18 years old and have no history of any medical illness that may confound study results or make participation in this protocol impossible
• Arm: individuals seropositive for HTLV
  Positive HTLV-1 ELISA followed by a positive Western Blot
• Arm: individuals with indeterminate HTLV sero-status
  Positive HTLV ELISA but a Western Blot that only partially fulfills criteria

Primary Outcome Measure

To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies. [ Time Frame: each study visit ]

Central Contacts

• Daniel S Reich, M.D.
  (301) 496-1801
  [email protected]
• Steven Jacobson, Ph.D.
  (301) 496-0519
  [email protected]

Locations (1)

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