Mood, Thinking and Memory Study: Children With/ Without Lupus
What is the purpose of this study?
The purpose of this research study is to find out whether mood, thinking, memory, visual skills and coordination skills of individuals with childhood-onset systemic lupus erythematosus (lupus) are different from individuals without lupus. Lupus is a complex autoimmune, rheumatic disease with symptoms that can range from mild to severe, affect any part of the body, and seriously challenge lupus patients and their families.
Who can participate?
Twenty children and adolescents ages 10 to16 years with lupus, as well as 20 healthy children and adolescents ages 10 to16 years, may be eligible to participate in this research study. Participants will be recruited from Cincinnati Children's Medical Center (Cincinnati Children’s) and Children's Memorial Hospital in Chicago.
What is involved?
This study lasts for 18 months and includes 4 visits for participants with lupus and three visits for healthy participants that will occur about every six months. The following is a list of procedures that will take place during the study:
- Physical exam and medication review
- Questionnaires filled out by the physician describing your disease (lupus participants only)
- Questionnaires filled out by participants that evaluate thinking, memory, mood, visual skills, and coordination skills. These questionnaires include both paper-and-pen and computerized sections.
- Formal neuropsychological testing. This will be a test administered by a trained professional at the Cincinnati Children’ s which will test your thinking, memory, visual skills, and coordination skills.
- An additional collection of blood (15 mL – approximately 3 teaspoons) at the time of regular blood draws at the participant's regularly scheduled clinic visit (lupus participants only).
- Some, but not all participants will be asked to take part in special imaging testing called functional magnetic resonance imaging (fMRI). This test will be used to observe the structure of your brain and how it functions while you’re performing special tasks.
What are the benefits?
Your child may receive no direct benefit from participating in this study. The biggest benefit is that you and your child may be helping other children and adults. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
Will I get all the facts about the study?
Parents will be given a consent form that thoroughly explains all of the details of the study. It includes all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until the parent/guardian or you, the participating study subject, have signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks and discomforts of the study?
There may be some discomfort when answering questions about certain aspects of your life. In addition, having your blood drawn can cause some minor discomfort including pain, bruising and dizziness. If you are eligible for the fMRI portion of the study, you may experience some nervousness in the scanner, but no pain is involved.
Do participants receive pay, compensation or reimbursement?
Participants with lupus can receive up to $200 for completing four visits over an 18 month period and healthy participants can receive up to $175 for completing three visits over an 18 month period.
Who should I contact for more information?
Cincinnati Children’s Hospital Medical Center
Department of Rheumatology, MLC 4010
3333 Burnet Ave., Cincinnati, OH 45229-3039