- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01191307
Assess Specific Kinds of Children Challenges for Neurologic Devices Study
24. října 2016 aktualizováno: 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.
Přehled studie
Postavení
Ukončeno
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
16
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
7 let až 15 let (Dítě)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
---|
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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Carlos L Pena, PhD, Food and Drug Administration (FDA)
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2009
Primární dokončení (Aktuální)
1. prosince 2014
Dokončení studie (Aktuální)
1. prosince 2014
Termíny zápisu do studia
První předloženo
26. srpna 2010
První předloženo, které splnilo kritéria kontroly kvality
26. srpna 2010
První zveřejněno (Odhad)
30. srpna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
25. října 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. října 2016
Naposledy ověřeno
1. října 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 09-006C
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Data sharing will occur via publication.
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .