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Assess Specific Kinds of Children Challenges for Neurologic Devices Study

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Carlos Pena, PhD, MS, Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier:
NCT01191307
First received: August 26, 2010
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
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.

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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assess Specific Kinds of Children Challenges for Neurologic Devices Study

Resource links provided by NLM:


Further study details as provided by Food and Drug Administration (FDA):

Enrollment: 16
Study Start Date: March 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   7 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191307

Sponsors and Collaborators
Carlos Pena, PhD, MS
Investigators
Principal Investigator: Carlos L Pena, PhD Food and Drug Administration (FDA)
  More Information

Responsible Party: Carlos Pena, PhD, MS, Senior Science Policy Advisor, Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier: NCT01191307     History of Changes
Other Study ID Numbers: 09-006C 
Study First Received: August 26, 2010
Last Updated: October 24, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Data sharing will occur via publication.

Keywords provided by Food and Drug Administration (FDA):
Primary dystonia
Epilepsy
Hydrocephalus
Bladder Control
Deaf or Hearing Impaired

Additional relevant MeSH terms:
Epilepsy
Dystonia
Dystonic Disorders
Hydrocephalus
Deafness
Hearing Loss
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Movement Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders

ClinicalTrials.gov processed this record on December 07, 2016