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.

Study Overview

• Status: Terminated
• Conditions: Epilepsy; Primary Dystonia; Hydrocephalus; Bladder Control; Hearing Impaired (Partially)

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.

• Study Type: Observational
• Enrollment (Actual): 16

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary Dystonia Criteria; Between ages 7 and 15 years of age, Approved medical device for Primary Dystonia, Neurologic device implanted within the past 12 months. Epilepsy Criteria; Between ages 12 and 15 years of age; Neurologic device implantation or surgical (in-hospital) adjustment within the past 12 months; Approved medical device. Pediatric Hydrocephalus Criteria; Between ages 7 and 15 years of age, Approved medical device, Neurologic shunt implantation or surgical (in-hospital) adjustment within the past 12 months. Spinal Cord Injury Criteria; Between ages 14 and 15 years of age, Approved medical device, Neurologic device implanted within the past 12 months. Deaf or Hearing Impaired Criteria; Between ages 7 and 15* years of age, Approved medical device.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Shunt Implant; hydropcephalus cohort
Cochlear Implant; hearing impaired cohort
Spinal Cord Stiumulation; spinal cord injury cohort
Vagus Nerve Stimulation; epilepsy cohort
Deep Brain Stimulation; dystonia cohort

Collaborators and Investigators

• Sponsor: Carlos Pena, PhD, MS
• Investigators: Principal Investigator: Carlos L Pena, PhD, Food and Drug Administration (FDA)

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 26, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Epilepsy; Hydrocephalus; Primary dystonia; Bladder Control; Deaf or Hearing Impaired
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Movement Disorders; Ear Diseases; Dyskinesias; Sensation Disorders; Hearing Disorders; Epilepsy; Hearing Loss; Dystonia; Dystonic Disorders; Deafness; Hydrocephalus
• Other Study ID Numbers: 09-006C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will occur via publication.