Assess Specific Kinds of Children Challenges for Neurologic Devices Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assess Specific Kinds of Children Challenges for Neurologic Devices Study

Conditions
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Primary Dystonia, Epilepsy, Hydrocephalus, Bladder Control, Hearing Impaired (Partially)

Participation Criteria
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Eligibility Criteria
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Primary Dystonia Inclusion Criteria Between ages 7 and 15 years of age; Implanted Medtronic Activa® Dystonia Therapy (approved or cleared by FDA for pediatric use). Neurologic device implanted within the past 12 months; Signed assent form document from the child Signed permission form from the parent/guardian); and Exclusion Criteria Participation in another clinical investigation that could be jeopardized by participation in the current study; Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures. Unable to comply with terms of the study Epilepsy Inclusion Criteria Between ages 12 and 15 years of age; Neurologic device implantation or surgical (in-hospital) adjustment within the past 12 months; NeuroCybernetic Prosthesis (NCP®) System (approved or cleared by FDA for pediatric use; the NCP® System is approved for children in ages 12 years and older). Signed assent form document from the child; and Signed permission form from the parent/guardian). Epilepsy Exclusion Criteria Participation in another clinical investigation that could be jeopardized by participation in the current study; and Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures.6 Unable to comply with terms of the study Pediatric Hydrocephalus Inclusion Criteria Between ages 7 and 15 years of age; Implanted traditional or adjustable hydrocephalus shunt implant (approved or cleared by FDA for pediatric use). Neurologic shunt implantation or surgical (in-hospital) adjustment within the past 12 months; Signed assent form document from the child Signed permission form from the parent/guardian) Pediatric Hydrocephalus Exclusion Criteria Participation in another clinical investigation that could be jeopardized by participation in the current study; and Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures.6 Unable to comply with terms of the study Spinal Cord Injury Inclusion Criteria Between ages 14 and 15 years of age; Vocare® Bladder System implant (approved or cleared by FDA for pediatric use). Neurologic device implanted within the past 12 months; Signed assent form document from the child Signed permission form from the parent/guardian); and Spinal Cord Injury Exclusion Criteria Participation in another clinical investigation that could be jeopardized by participation in the current study; and Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures. Unable to comply with terms of the study Deaf or Hearing Impaired Inclusion Criteria Between ages 7 and 15* years of age; Implanted cochlear implant (approved or cleared by FDA for pediatric use) with any device adjustment related to device performance or routine care of their current device within the past 12 months; Signed assent form document from the child Signed permission form from the parent/guardian); and Deaf or Hearing Impaired Exclusion Criteria Participation in another clinical investigation that could be jeopardized by participation in the current study; and Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures. Unable to comply with terms of the study

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shunt Implant<br>hydropcephalus cohort | |
| Cochlear Implant<br>hearing impaired cohort | |
| Spinal Cord Stiumulation<br>spinal cord injury cohort | |
| Vagus Nerve Stimulation<br>epilepsy cohort | |
| Deep Brain Stimulation<br>dystonia cohort | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary dystonia, Epilepsy, Hydrocephalus, Bladder Control, Deaf or Hearing Impaired