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Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment (CoCoTA)

16. mai 2019 oppdatert av: SangYun Kim, Seoul National University Bundang Hospital

Effectiveness of Computerized Cognitive Training Apparatus (CoCoTA) in the Elderly With Normal Cognition, Subjective Cognitive Impairment, Mild Cognitive Impairment

This study is to investigate the effectiveness of computerized cognitive training, and corresponding neural substrates through multimodal neuroimaging assessment, in the elderly with normal cognition, subjective cognitive impairment, and mild cognitive impairment.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Computerized cognitive training has the advantage of easy accessibility for community-dwelling elderly. It can be much cheaper than traditional neuropsychological training methods, which require trained neuropsychologists. Furthermore, it may be more fun and easier to be optimized to an individual patients' cognitive status than other traditional methods.

Clinical efficacy of these kinds of cognitive training applications has been validated through several studies. A recent systematic review reported that the domains of working memory, executive function, and processing speed benefited the most by classic computerized cognitive training tasks, and that these benefits were comparable with traditional cognitive training methods. Apart from neuropsychological data, neuroimaging studies focusing on the effectiveness of computerized cognitive training are scant.

There have been no previous studies investigating the possible neural substrates of computerized cognitive training using multimodal neuroimaging modalities simultaneously. Thus, we aimed to investigate the effectiveness of computerized cognitive training and corresponding neural substrates in subjects with mild cognitive impairment, subjective memory impairment, and normal controls through a multimodal approach.

Studietype

Intervensjonell

Registrering (Faktiske)

26

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

51 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Ages >50 to ≤70
  • Years of education ≥ 6 years
  • No physical barrier preventing the dominant hand from using the computer mouse

Exclusion Criteria:

  • Subjects who had any structural lesions or psychiatric disorders that explained the memory deficits
  • Subjects had to be able to undergo pre- and post-training evaluations such as electroencephalography (EEG), FDG-PET, and magnetic resonance imaging (MRI)
  • Subjects who had scalp lesions, severe back pain, or claustrophobia that precluded pre- and post-training evaluations.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Mild cognitive impairment
Intervention: Computerized Cognitive Training Apparatus
Atferdsmessig: Computerized Cognitive Training Apparatus

CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia.

Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process.

Andre navn:
  • CoCoTA
Eksperimentell: Subjective cognitive impairment
Intervention: Computerized Cognitive Training Apparatus
Atferdsmessig: Computerized Cognitive Training Apparatus

CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia.

Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process.

Andre navn:
  • CoCoTA
Aktiv komparator: Normal controls
Intervention: Computerized Cognitive Training Apparatus
Atferdsmessig: Computerized Cognitive Training Apparatus

CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia.

Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process.

Andre navn:
  • CoCoTA

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical improvement in the follow-up neuropsychological tests
Tidsramme: 12 weeks
changes in memory and frontal domain subscores between the baseline and follow-up
12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cortical thickness changes between baseline and follow-up volumetric MRI
Tidsramme: 12 weeks
surface-based morphometry using freesurfer software
12 weeks
White matter integrities changes between baseline and follow-up diffusion tensor imaging
Tidsramme: 12 weeks
tract-based spatial statistics using fsl software
12 weeks
Spectral ratio changes between baseline and follow-up EEG
Tidsramme: 12 weeks
EEG spectral ratio analysis
12 weeks
local activation pattern changes between baseline and follow-up Fludeoxyglucose PET
Tidsramme: 12 weeks
local activation pattern analysis using SPM
12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Seoul National University Bundang Hospital

Etterforskere

  • Hovedetterforsker: SangYun Kim, MD,PhD, Seoul National University Bundang Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2012

Primær fullføring (Faktiske)

1. april 2013

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

22. juni 2015

Først innsendt som oppfylte QC-kriteriene

23. juni 2015

Først lagt ut (Anslag)

24. juni 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 10035434

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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