NCT01132885 Defining the Brain Phenotype of Children With Williams Syndrome
| NCT ID | NCT01132885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Williams Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 415 participants |
| Start Date | 2011-01-23 |
| 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 415 participants in total. It began in 2011-01-23.
⚠ 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
Background: \- Little is known about how the brain changes during childhood and adolescence, how genes affect this process, or how the brains of people with 7q11.23 genetic variation change during this period. Researchers are interested in using magnetic resonance imaging to study how the brain changes in healthy children and children with 7q11.23 genetic variation, including Williams syndrome and 7q11.23 duplication syndrome. Objectives: \- To study developmental changes in the brains of healthy children and children who have been diagnosed with Williams syndrome,7q11.23 duplication syndrome, or other 7q11.23 genetic variation. Eligibility: * Healthy children and adolescents between 5 and 17 years of age. * Children and adolescents between 5 and 17 years of age who have been diagnosed with Williams syndrome, 7q11.23 duplication syndrome, or have other 7q11.23 genetic variation. Design: * Participants will have a brief physical examination and tests of memory, attention, concentration, and thinking. Parents will be asked about their child s personality, behavior characteristics, and social interaction and communication skills. * Both participants and their parents may be asked to complete additional questionnaires or take various tests as required for the study. * Participants will have approximately 10 hours of magnetic resonance imaging (MRI) scanning, usually over 4 to 5 days, within a one month period. Some of these tests will require the participants to do specific tasks while inside the MRI scanner. * Participants will be asked to return to the National Institutes of Health clinical center to repeat these procedures every 2 years thereafter until age 18.
Eligibility Criteria
* INCLUSION CRITERIA: For all participants, the following inclusion criteria will apply: 1. Greater than 5 years old. 2. Able to provide assent if below the age of 18, or consent if 18 years of age or older. Parents will provide consent for participants below the age of 18. For patients who do not have the capacity to provide informed consent, consent may be obtained from a guardian or the holder of the DPA. Additionally, 7q11.23 CNV participants must have a typical, 7q11.23 CNV or other genetic abnormality in the Williams syndrome critical region of chromosome 7q11.23, and control participants must have normal intelligence. EXCLUSION CRITERIA: For all participants who will participate in MRI scanning, the following exclusion criteria will apply: 1. Any chronic or acute medical condition severe enough to interfere with task performance or interpretation of MRI data. 2. Any medication that might interfere with task performance or interpretation of MRI data. 3. Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye or other body part, dental braces). 4. Pregnancy (a urine pregnancy test will be performed prior to all MRI procedures for all females of child-bearing potential. 5. NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy. For parents who will undergo blood draws only, they will not be able to participate if they have a condition that would make collecting blood unsafe.
Contact & Investigator
Karen F Berman, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT01132885 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Williams Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01132885 currently recruiting?
Yes, NCT01132885 is actively recruiting participants. Contact the research team at tiffany.nash@nih.gov for enrollment information.
Where is the NCT01132885 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT01132885 clinical trial?
NCT01132885 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Karen F Berman, M.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 415 participants.