- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00061399
Prospective Memory in Children With Traumatic Brain Injury
Prospective Memory in Normal and Head-Injured Children
Studieoversikt
Status
Forhold
Detaljert beskrivelse
While much has been learned about how children with TBIs learn and recall stories, word lists, and pictures, little is known about how they perform PM tasks. Impairment in PM could have serious implications for academic and vocational pursuits. This study will investigate PM in children with mild or severe TBI. The study will focus on three major themes: 1) strategies that may help children with TBI overcome or minimize their PM deficits; 2) how specific areas of cognition can be impaired following TBI and in turn impair PM; and 3) the impact of PM deficits on a child's daily functioning, both at school and at home. The study will also evaluate children without TBI (control group).
Each child will participate in one study evaluation. The evaluation will last approximately 4 hours, with a lunch break and other rest breaks as necessary. Assessments will include neuropsychological tests of attention, memory, and general intellectual functioning. Experimental tasks will include measures of metacognition for prospective memory, elucidation of strategic versus automatic processes involved in PM, and the effect of motivation manipulations in overcoming PM deficits with varying working memory loads. The child's parent or guardian will also be asked to complete some tests to measure the impact of PM deficits on the child's daily home life.
Studietype
Registrering
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
- English speaker
- Minimum birth weight of 2500 grams (5.5 lbs) and 37 weeks' gestation
Additional Inclusion Criteria for Children with Traumatic Brain Injury
- Head injury resulting in a post-resuscitation Glasgow Coma Scale score of either 13 to 15 or 3 to 8
- No evidence of hypoxic injury
Exclusion Criteria
- History of epilepsy, mental retardation, or documented evidence of developmental dysfunction
- Previous hospitalization for head injury involving loss of consciousness or post-concussional symptoms
- History of autism, major psychiatric disorder, or pervasive developmental delay
- History of meningitis or encephalitis
- History of child abuse
- History of chronic or uncontrolled serious physical disorders (cancer, uncontrolled diabetes, cystic fibrosis, etc.)
- Note: siblings of participants with TBI or orthopedically-injured comparison children will not be enrolled to maintain the independence of the groups
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Stephen R. McCauley, Ph.D., Baylor College of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K23HD040896 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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