Assess Specific Kinds of Children Challenges for Neurologic Devices Study
Recruitment status was Recruiting
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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. 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.
| Condition |
|---|
|
Primary Dystonia Epilepsy Hydrocephalus Bladder Control Deaf or Hearing Impaired |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Assess Specific Kinds of Children Challenges for Neurologic Devices Study |
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Shunt Implant |
| Cochlear Implant |
| Spinal Cord Stiumulation |
| Vagus Nerve Stimulation |
| Deep Brain Stimulation |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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, Signed assent form document from the child. 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. Signed assent form document from the child. 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, Signed assent form document from the child. Spinal Cord Injury Criteria; Between ages 14 and 15 years of age, Approved medical device, Neurologic device implanted within the past 12 months,Signed assent form document from the child. Deaf or Hearing Impaired Criteria; Between ages 7 and 15* years of age, Approved medical device, Signed assent form document from the child.
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| United States, Arkansas | |
| John Chelonis | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: John Chelonis, PhD 501-364-3319 john.chelonis@fda.hhs.gov | |
| United States, Maryland | |
| FDA | Recruiting |
| Rockville, Maryland, United States, 20852 | |
| Contact: Carlos Pena, PhD 301-796-8521 carlos.pena@fda.hhs.gov | |
| Contact: Kristen Bowsher 301-796-6448 kristen.bowsher@fda.hhs.gov | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Neil Friedman, MBchB 216-444-6773 friedmn@ccf.org | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Carlos Pena, FDA |
| ClinicalTrials.gov Identifier: | NCT01191307 History of Changes |
| Other Study ID Numbers: | 09-006C |
| Study First Received: | August 26, 2010 |
| Last Updated: | August 26, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Food and Drug Administration (FDA):
|
Primary dystonia Epilepsy Hydrocephalus Bladder Control Deaf or Hearing Impaired |
Additional relevant MeSH terms:
|
Deafness Hearing Loss Dystonia Dystonic Disorders Epilepsy Hydrocephalus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Dyskinesias Movement Disorders Central Nervous System Diseases Brain Diseases Intracranial Hypertension |
ClinicalTrials.gov processed this record on June 18, 2013