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Assess Specific Kinds of Children Challenges for Neurologic Devices Study

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
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