Assess Specific Kinds of Children Challenges for Neurologic Devices Study

Terminated

• Conditions: Primary Dystonia; Epilepsy; Hearing Impaired (Partially); Hydrocephalus; Bladder Control

• Registration Number: NCT01191307
• Lead Sponsor: Carlos Pena, PhD, MS

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-30
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified