Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes - NCT00879515-95817(Clinical Trial 283534)
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Sacramento |
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State:
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CA |
| Zip Code: |
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95817 |
| Conditions: |
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Anxiety Disorders - Child Developmental Disorders, Pervasive |
| Purpose: |
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By testing physiological responses to anxiety in people with nervous system developmental
disorders, this study will identify specific physiological characteristics associated with
response to anxiety treatments.
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| Study summary: |
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Anxiety is a common and significant problem for people suffering from disorders of nervous
system development, including fragile X syndrome. There are few validated treatments for
anxiety in people with these disorders, in part because the biological basis of anxiety in
neurodevelopmental disorders has not been clearly described. This study will evaluate the
physiological responses of people with fragile X syndrome, Down syndrome, and the fragile X
premutation (a mild version of the genes that cause fragile X syndrome) to a variety of
sensory, emotional, and social stimuli. By analyzing the data collected for this study,
researchers aim to identify physiological characteristics linked to subgroups within the
disorders, demonstrate links between physiological responses and behavioral or psychiatric
symptoms, and measure physiological changes in people receiving treatment for their
disorders.
Participation in this study will include one testing session, which will take between 3 and
3.5 hours. Participants who receive treatment for their anxiety may be asked to complete
this testing a second time, after their treatment. During the testing session, sensors will
be placed on participants' skin in several locations to measure heart rate, sweat response,
and eye-blinks. Participants will then be asked to respond to multiple stimuli: sounds,
lights, smells, pictures that elicit different types of emotions, an interaction with an
unfamiliar person, and specialized toys. In addition, participants will undergo blood
testing and have several samples of their saliva collected on the day of the testing
session. Participants will also be asked to collect additional saliva samples at home three
times a day on 4 different days. Child participants and their parents may also be asked to
complete questionnaires and interviews about behavioral and emotional problems. |
| Criteria: |
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Inclusion Criteria:
- Fragile X premutation or fragile X syndrome, measured by DNA testing; Down syndrome,
confirmed by chromosomal analysis; or normally developing control
- Normal hearing |
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| Study is available at: |
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M.I.N.D. Institute, University of California, Davis
Sacramento, CA 95817
United States
Primary Contact:
Lisa Cordeiro
Email: lisa.cordeiro@ucdmc.ucdavis.edu
Phone: 916-703-0353
Secondary Contact:
Lisa Cordeiro, BA
Email: lisa.cordeiro@ucdmc.ucdavis.edu
Phone: 916-703-0353 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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