Prospective multicenter clinical study on outcome measures for HTLV-1-associated myelopathy (HAM)

Prospective multicenter clinical study on outcome measures for HTLV-1-associated myelopathy (HAM) - HAM-OM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000012874

Enrollment

150

Registered

2014-01-16

Start date

2014-01-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with HAM according to the WHO guidelines (Kagoshima Science Council 1988) 2.The patient truly consents to participate in the study of his or her own free will (in the case of minors, requires consent of the legal guardian)

Exclusion criteria

Exclusion criteria: 1. Patients with spinal cord compression lesion complications such as from cervical spine disease,intervertebral disc herniation, or yellow ligament ossification that affect gait assessment 2. Patients with knee or hip osteoarthritis, rheumatoid arthritis, or another musculoskeletal disease that affects gait assessment 3. Patients with Parkinsons disease or the aftereffects of stroke, cerebral hemorrhage, subarachnoid hemorrhage or other neurological disturbance affecting gait assessment 4. Serious complications that affect gait assessment (heart failure, respiratory dysfunction, renal failure, liver failure, etc.) 5. Patients with mental disorders such as dementia or neuropsychiatric diseases that affect ability to answer interview questions 6. Patients with any disease other than HAM for which they might be prescribed steroids (excluding topic medicines), interferon, or anti-cancer drugs 7. Patients with both severe anemia (hemoglobin less than 9.0 g/dl) and intracranial hypotension syndrome from whom it is deemed unwise with regard to the subjects safety to collect blood or CSF samples 8. Patients who have been deemed unfit for the study by a study investigator or physician.

Design outcomes

Primary

Measure	Time frame
Motor impairment severity, time for 10 meter walk, distance walked in 2 minutes 1) Blood and CSF<Blood>Serum concentrations of sIL-2R, CXCL10, and CXCL9; HTLV-1 proviral load in PBMCs <CSF>Cell count, anti-HTLV-1 antibody titer, neopterin, CXCL9, CXCL10, CXCL13, HTLV-1 proviral load in cells in the CSF 2) Proteomic analysis of the plasma and CSF 3) Whole genomic analysis of PBMC-derived DNA, copy number variation analysis, peripheral blood RNA expression analysis	—

Measure

Time frame

Motor impairment severity, time for 10 meter walk, distance walked in 2 minutes 1) Blood and CSF<Blood>Serum concentrations of sIL-2R, CXCL10, and CXCL9; HTLV-1 proviral load in PBMCs <CSF>Cell count, anti-HTLV-1 antibody titer, neopterin, CXCL9, CXCL10, CXCL13, HTLV-1 proviral load in cells in the CSF 2) Proteomic analysis of the plasma and CSF 3) Whole genomic analysis of PBMC-derived DNA, copy number variation analysis, peripheral blood RNA expression analysis

—

Secondary

Measure	Time frame
4) Treatment contents 5) QOL indicators	—

Countries

Japan

Contacts

Public ContactYoshihisa Yamano

St. Marianna University School of Medicine Division of Neurology, Department of Internal Medicine

yyamano@marianna-u.ac.jp044-977-8111

Outcome results