Study:
Assess Specific Kinds of Children Challenges for Neurologic Devices Study
Rationale:
n/a
Purpose:
The ASK CHILDREN study is intended to aid in future development of various neurologic
devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information
obtained to identify more efficient strategies in the evaluation and review of
neuroprostheses regulated by the Agency. Specific aims of the clinical study include: (1)
Collecting qualitative and quantitative self-report clinical data (through interviews) from
children undergoing treatment related to human factors, safety, usability, and adverse
events in patients ages 7 to 15 years old implanted with a neuroprosthesis targeting the
brain or spinal cord (at two 6 month intervals); and (2) Establish a science-based framework
of recommendations based upon the data collected in the ASK CHILDREN Study to help develop
more efficient strategies in evaluating pediatric neuroprostheses regulated by the Agency.
Study Status: Recruiting
Recruiting:
Neil Friedman, MBchB 216-444-6773 friedmn@ccf.org
| Condition |
Intervention |
Phase |
Primary Dystonia
Epilepsy
Hydrocephalus
Bladder Control
Deaf or Hearing Impaired |
n/a |
N/A |
Verified by
Food and Drug Administration (FDA)
August, 2010
Sponsored by: Food and Drug Administration (FDA)
Information provided by: Food and Drug Administration (FDA)
ClinicalTrials.gov identifier: NCT01191307
Study Type: Interventional
Study Design: Time Perspective: Prospective
Cleveland Clinic
Cleveland, Ohio 44106
United States
n/a