Ask Children Study
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Our study collects information directly from children and adolescents with neurologic devices in order to identify scientific and medical issues that may help develop more efficient strategies for evaluating these devices by FDA and hasten such devices to market. Our study queries patients about their experiences with neurologic devices and targets patients between the ages of 7 and 15 years old (except as noted) with one of the following five neurologic devices:
Our study aims to enroll a total of approximately 100 children and adolescents and participation requires two interviews, approximately 6 months apart, with study investigators. Currently visits can take place at FDA in Maryland, the Cleveland Clinic, and Arkansas Children's Hospital. We also are awaiting IRB approval at the Children's National Medical Center in Washington, DC. The use of questionnaires is part of the study and all participants are requested to complete questionnaires following each visit; questionnaires include questions primarily about quality of life. All patients will receive an FDA T-shirt for study participation and a gift card following return receipt of completed questionnaires following each interview.
The study is also posted on www.clinicaltrials.gov as well as an independent website accessible at http://www.askchildrenstudy.org/welcome.htm.
Carlos Peña, PhD, MS
Senior Science Policy Advisor
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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Last revised 08-Feb-2011 by Steven Leber