Assess Specific Kinds of Children Challenges for Neurologic Devices Study

NCT01191307 | Terminated DMC

• 1 other identifier: 09-006C
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Dystonia; Epilepsy; Hydrocephalus; Bladder Control; Hearing Impaired (Partially)

Keywords

Primary dystonia; Epilepsy; Hydrocephalus; Bladder Control; Deaf or Hearing Impaired

Study Arms (5)

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

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).
• 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
• 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

Sponsors & Collaborators

• Carlos Pena, PhD, MS: lead

MeSH Terms

Conditions

Dystonic Disorders; Epilepsy; Hydrocephalus; Hearing Loss

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos L Pena, PhD

  Food and Drug Administration (FDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Science Policy Advisor

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share