Assess Specific Kinds of Children Challenges for Neurologic Devices Study

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.

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