Assess Specific Kinds of Children Challenges for Neurologic Devices Study

Carlos Pena, PhD, MS

Status

Terminated

Conditions

Hydrocephalus

Epilepsy

Hearing Impaired (Partially)

Primary Dystonia

Bladder Control

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT01191307

09-006C

Details and patient eligibility

About

Full 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.

Enrollment

16 patients

Sex

All

Ages

7 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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