Trial record 14 of 123 for:    Open Studies | "Hearing Disorders"

Assess Specific Kinds of Children Challenges for Neurologic Devices Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Food and Drug Administration (FDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier:
NCT01191307
First received: August 26, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Food and Drug Administration (FDA):

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
Study Population

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191307

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   
Sponsors and Collaborators
Food and Drug Administration (FDA)
  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:
Hearing Disorders
Deafness
Hearing Loss
Dystonia
Dystonic Disorders
Epilepsy
Hydrocephalus
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 August 26, 2014