Institutional Review Board, Hospital for Special Surgery
May 05, 2008
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
This study will enroll 40 lupus or antiphospholipid antibody positive patients for the administration of tests to examine general mental function and pictures of the brain (MRI). The purpose of the study is to measure mental abilities such as ability to concentrate and to remember things, and to examine any potential abnormalities in brain MRI pictures.
Selected Inclusion Criteria:
• Ages of 18 and 50
• Diagnosis of lupus
• Positive antiphospholipid antibody tests (i.e., lupus anticoagulant test, anticardiolipin antibody test, and/or anti-β2-glycoprotein-I antibody test)
Selected Exclusion Criteria:
• Non-English speaking patients,
• History of other systemic autoimmune disorder (such as rheumatoid arthritis or scleroderma),
• History of stroke
• History of other psychiatric or neurological disorder (such as epilepsy, multiple sclerosis, prior traumatic brain injury or brain tumor),
• Substance abuse, active illegal drug use or use,
• Prior neuropsychological testing within the past year, or
• Metal implants that interfere with safety for MIR procedures.
Subjects will be paid $100.00 at the completion of the study