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- Essai clinique NCT01191307
Assess Specific Kinds of Children Challenges for Neurologic Devices Study
24 octobre 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
16
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
7 ans à 15 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Carlos L Pena, PhD, Food and Drug Administration (FDA)
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2009
Achèvement primaire (Réel)
1 décembre 2014
Achèvement de l'étude (Réel)
1 décembre 2014
Dates d'inscription aux études
Première soumission
26 août 2010
Première soumission répondant aux critères de contrôle qualité
26 août 2010
Première publication (Estimation)
30 août 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
25 octobre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 octobre 2016
Dernière vérification
1 octobre 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Manifestations neurologiques
- Maladies oto-rhino-laryngologiques
- Troubles du mouvement
- Maladies de l'oreille
- Dyskinésies
- Troubles des sensations
- Troubles auditifs
- Épilepsie
- Perte d'audition
- Dystonie
- Troubles dystoniques
- Surdité
- Hydrocéphalie
Autres numéros d'identification d'étude
- 09-006C
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Data sharing will occur via publication.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .