Assess Specific Kinds of Children Challenges for Neurologic Devices Study

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Brief Title

Assess Specific Kinds of Children Challenges for Neurologic Devices Study

Official Title

Assess Specific Kinds of Children Challenges for Neurologic Devices Study

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.
    


Study Type

Observational




Condition

Primary Dystonia


Study Arms / Comparison Groups

 Shunt Implant
Description:  hydropcephalus cohort

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

16

Start Date

March 2009

Completion Date

December 2014

Primary Completion Date

December 2014

Eligibility 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
      

Gender

All

Ages

7 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

Carlos L Pena, PhD, , 



Administrative Informations


NCT ID

NCT01191307

Organization ID

09-006C


Responsible Party

Sponsor-Investigator

Study Sponsor

Carlos Pena, PhD, MS


Study Sponsor

Carlos L Pena, PhD, Principal Investigator, Food and Drug Administration (FDA)


Verification Date

October 2016