Assess Specific Kinds of Children Challenges for Neurologic Devices Study

Epilepsy Clinical Trial

Official title: Assess Specific Kinds of Children Challenges for Neurologic Devices Study

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Control
• Deafness
• Dystonia
• Dystonic Disorders
• Epilepsy
• Hearing Impaired (Partially)
• Hearing Loss
• Hydrocephalus
• Primary Dystonia

• NCT number: NCT01191307
• Study type: Observational
• Source: Food and Drug Administration (FDA)
• Status: Terminated
• Phase: N/A
• Start date: March 2009
• Completion date: December 2014