Sickle Cell Adult Neurological Dysfunction (SCAN) Study
What is the purpose of this study?
The Sickle Cell Adult Neurological Dysfunction (SCAN) research study examines brain structure and memory and attention function in adults with sickle cell disease. The study will use magnetic resonance imaging (MRI) to examine the brain structure and neuropsychological testing to examine brain function of adults with sickle cell disease in order to find possible links to memory and attention problems. The MRI and testing results will be compared with MRI and testing results of adults with similar backgrounds who do not have sickle cell disease. Study researchers will also attempt to find out if certain treatments, such as blood transfusions, can improve memory and attention problems.
Who will be included in this study?
Participants should be 21 to 55 years old and have been diagnosed with sickle cell disease. Adults ages 21 to 55 who have not been diagnosed with sickle cell disease will also participate in the study. People who have had a stroke, are pregnant, or may become pregnant should not participate in this research study.
What is involved?
This study lasts about one month and requires four visits to Cincinnati Children's Hospital Medical Center. During Visit 1, a research team member will ask the participant several questions to determine eligibility. Several forms will be completed by the participant, and a small quantity of blood, about a teaspoonful, will be drawn. During Visits 2 and 3, the participant will meet with a specially trained psychologist who will perform neuropsychological testing. The testing lasts four to six hours. An MRI will be performed at Cincinnati Children's Hospital Medical Center. Visit 4 is a follow-up visit. Participants will receive a summary of the test results and have an opportunity to meet with a medical professional to go over the results and to ask questions. If the test results indicate potential problems, participants will be given specific recommendations about what should be done.
What are the benefits?
There may not be any direct benefit to participants who take part in this study. This study may add to research team's knowledge about memory and attention in adults with sickle cell disease and may lead to better understanding of sickle cell disease and better treatment for sickle cell disease patients. A potential benefit to participants in the study is that formerly unknown abnormalities in brain structure or function may be identified. This information may be useful to the participant and the participant's doctor in planning medical care.
Will I get all the facts about the study?
Adults interested in participating will be scheduled with a member of the research team who will thoroughly explain all of the details of the study. They will review the consent form with the potential participant and will be sure that all questions are answered. The consent form goes over all of the procedures, risks, benefits, compensation, who to contact with questions or concerns and more. Study procedures will not begin until the adult has signed this form.
What are the risks?
Having blood drawn for laboratory tests will cause brief pain and possibly bruising from the needle stick.There are no known risks associated with filling out questionnaires or completing the neuropsychological testing. These activities may be tiring or stressful. There are no known risks from MRI studies, which use far less energy than a single x-ray. Although MRI scans are painless, participants may feel some discomfort from loud noises, the feeling of being closed in while inside the scanner or from sensations on the skin that resemble gentle taps. Because the MRI scanner attracts some metals, it is important for the participant to let the MRI technician know if any metal objects are in his/her body, including a pacemaker or hardware from surgery. MRI scans can affect unborn children, so it is important to inform the research team of pregnancy during the research study.
What is the compensation?
For participating in the study, you will receive a total of $240 for your time and $60 for transportation. If you do not complete the study, you will receive pro-rated compensation for the visits you do complete.
Who should I contact for more information?
Grace McIntyre-Patton, RN
Cincinnati Children's Hospital Medical Center
Division of Hematology / Oncology
3333 Burnet Ave.
Cincinnati, OH 45229-3039
513-636-1362
sicklecell@cchmc.org
