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Assess Specific Kinds of Children Challenges for Neurologic Devices Study

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ClinicalTrials.gov Identifier: NCT01191307
Recruitment Status : Terminated (Slow enrollment)
First Posted : August 30, 2010
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Carlos Pena, PhD, MS, Food and Drug Administration (FDA)

August 26, 2010
August 30, 2010
October 25, 2016
March 2009
December 2014   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01191307 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assess Specific Kinds of Children Challenges for Neurologic Devices Study
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.
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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Primary Dystonia
  • Epilepsy
  • Hydrocephalus
  • Bladder Control
  • Hearing Impaired (Partially)
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
100
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01191307
09-006C
Yes
Not Provided
Plan to Share IPD: No
Plan Description: Data sharing will occur via publication.
Carlos Pena, PhD, MS, Food and Drug Administration (FDA)
Carlos Pena, PhD, MS
Not Provided
Principal Investigator: Carlos L Pena, PhD Food and Drug Administration (FDA)
Food and Drug Administration (FDA)
October 2016