Assess Specific Kinds of Children Challenges for Neurologic Devices Study

NCT ID: NCT01191307

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Shunt Implant

hydropcephalus cohort

No interventions assigned to this group

Cochlear Implant

hearing impaired cohort

No interventions assigned to this group

Spinal Cord Stiumulation

spinal cord injury cohort

No interventions assigned to this group

Vagus Nerve Stimulation

epilepsy cohort

No interventions assigned to this group

Deep Brain Stimulation

dystonia cohort

No interventions assigned to this group

Eligibility Criteria

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

• 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).

• 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)

• 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

• 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

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

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carlos Pena, PhD, MS

FED

Sponsor Role: lead

Responsible Party

Carlos Pena, PhD, MS

Senior Science Policy Advisor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carlos L Pena, PhD

Role: PRINCIPAL_INVESTIGATOR

Food and Drug Administration (FDA)

Other Identifiers

09-006C

Identifier Type: -

Identifier Source: org_study_id