Assess Specific Kinds of Children Challenges for Neurologic Devices Study

October 24, 2016 updated by: Carlos Pena, PhD, MS
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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. 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. 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. Spinal Cord Injury Criteria; Between ages 14 and 15 years of age, Approved medical device, Neurologic device implanted within the past 12 months. Deaf or Hearing Impaired Criteria; Between ages 7 and 15* years of age, Approved medical device.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Shunt Implant
hydropcephalus cohort
Cochlear Implant
hearing impaired cohort
Spinal Cord Stiumulation
spinal cord injury cohort
Vagus Nerve Stimulation
epilepsy cohort
Deep Brain Stimulation
dystonia cohort

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carlos Pena, PhD, MS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlos L Pena, PhD, Food and Drug Administration (FDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-006C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing will occur via publication.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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