Evaluation of Patients With HAM/TSP
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 pa
| Condition(s) | HTLV-I Infection, Tropical Spastic Paraparesis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 immunologica |
| Who can participate | * 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 t |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Locations | Bethesda, Maryland, United States |
| Start date | 1998-04-06 |
| NCT ID | NCT00001778 |
| Official listing | https://clinicaltrials.gov/study/NCT00001778 |