Bladder Control, Epilepsy, Hearing Impaired (Partially), Hydrocephalus, Primary Dystonia
Conditions
Keywords
Primary dystonia, Epilepsy, Hydrocephalus, Bladder Control, Deaf or Hearing Impaired
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.
Interventions
None listed
Sponsors
Carlos Pena, PhD, MS
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion 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
Outcome results
None listed