Status:
TERMINATED
Assess Specific Kinds of Children Challenges for Neurologic Devices Study
Lead Sponsor:
Carlos Pena, PhD, MS
Conditions:
Primary Dystonia
Epilepsy
Eligibility:
All Genders
7-15 years
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 ef...
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 ef...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01191307
Start Date
March 1 2009
End Date
December 1 2014
Last Update
October 25 2016
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