Assess Specific Kinds of Children Challenges for Neurologic Devices Study

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