| NCT ID | NCT00001778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Condition | HTLV-I Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 1998-04-06 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 1998-04-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
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.
Contact & Investigator
Steven Jacobson, Ph.D.
PRINCIPAL INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently Asked Questions
Who can join the NCT00001778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying HTLV-I Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00001778 currently recruiting?
Yes, NCT00001778 is actively recruiting participants. Contact the research team at reichds@ninds.nih.gov for enrollment information.
Where is the NCT00001778 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00001778 clinical trial?
NCT00001778 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). The principal investigator is Steven Jacobson, Ph.D. at National Institute of Neurological Disorders and Stroke (NINDS). The trial plans to enroll 750 participants.