- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02538445
Can we Forget? Directed Forgetting and Embodied Cognition in Schizophrenia
22 mars 2016 uppdaterad av: Centre Hospitalier Universitaire de Saint Etienne
Based on the theory of embodied cognition, which focuses on the influence of sensory and motor processes on cognition, researchers propose to study the influence of the action on memorization and inhibition in patients suffering from schizophrenia, using a directed forgetting paradigm.
The directed forgetting paradigm is used, composed of two lists of action verbs.
The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug.
Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)).
A recognition task is performed at the end.
The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only.
48 schizophrenic patients were included in this study.
Patients were randomized to have 10 participants per condition.
48 controls matched by age, gender, laterality and education are also included and randomized in the same modality.
This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Researchers used the directed forgetting paradigm composed of two lists of action verbs.
The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug.
Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)).
A recognition task is performed at the end.
The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only.
48 schizophrenic patients were included in this study.
Patients were randomized to have 10 participants per condition.
48 controls matched by age, gender, laterality and education are also included and randomized in the same modality.
This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.
Studietyp
Interventionell
Inskrivning (Faktisk)
96
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Saint Etienne, Frankrike, 42000
- CHU de Saint-Etienne
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria for patients:
- Schizophrenic patients as defined in Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)
- Stabilized a therapeutic point of view for at least one month.
- Consent form signed
- Affiliated to a Security Health Program
Inclusion Criteria for volunteers:
- Consent form signed
- Affiliated to a Security Health Program
Exclusion Criteria for patients and volunteers :
- Not having a history of head trauma, neurological disease or not stabilized serious somatic illness,
- Not to use psychoactive substance, as defined by the DSM IV.
- The Intelligence Quotient must not be less than 70 (Progressive Matrices Standard score (PM38), Raven Progressive Matrix).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Patients group 1
Memorization of the verbs by miming the action
|
The participant reads aloud the verbs that appear on the screen, by performing the corresponding action verb.
|
|
Experimentell: Patients group 2
Memorization of the verbs by imagining the action
|
The participant reads aloud the verbs that appear on the screen, by imagining the corresponding action verb.
|
|
Experimentell: Patients group 3
Memorization of the action verbs by means of another word
|
The participant reads aloud the verbs that appear on the screen.
Then, he reads, without memorizing it, a word associated with the action verb to be learnt to favor the memorization of that one.
The word is written near the action verb.
|
|
Experimentell: Patients group 4
Simple memorization of the verbs
|
The participant reads aloud the verbs that appear on the screen, without additional instructions (control condition).
|
|
Aktiv komparator: Healthy volonteers group 1
Memorization of the verbs by miming the action
|
The participant reads aloud the verbs that appear on the screen, by performing the corresponding action verb.
|
|
Aktiv komparator: Healthy volonteers group 2
Memorization of the verbs by imagining the action
|
The participant reads aloud the verbs that appear on the screen, by imagining the corresponding action verb.
|
|
Aktiv komparator: Healthy volonteers group 3
Memorization of the action verbs by means of another word
|
The participant reads aloud the verbs that appear on the screen.
Then, he reads, without memorizing it, a word associated with the action verb to be learnt to favor the memorization of that one.
The word is written near the action verb.
|
|
Aktiv komparator: Healthy volonteers group 4
Simple memorization of the verbs
|
The participant reads aloud the verbs that appear on the screen, without additional instructions (control condition).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of items recalled TBR and TBF
Tidsram: Day 1
|
It is asked to the participants to recall orally, only TBR verbs (task of reminder).
The experimenter notes the given verbs.
|
Day 1
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of recognized items
Tidsram: Day 1
|
Participants must recognize TBR verbs among several verbs (distractor or TBF verbs) on the screen.The experimenter notes the recognized verbs. The recognition of a verb in the TBF list or a distractor is considered like an error. |
Day 1
|
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Reaction time (ms) on the recognition of TBR and TBF
Tidsram: Day 1
|
The response times of participants are recorded in ms.
|
Day 1
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Anne GROSSELIN, MD, CHU de Saint-Etienne
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2011
Primärt slutförande (Faktisk)
1 december 2012
Avslutad studie (Faktisk)
1 december 2012
Studieregistreringsdatum
Först inskickad
31 augusti 2015
Först inskickad som uppfyllde QC-kriterierna
31 augusti 2015
Första postat (Uppskatta)
2 september 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 mars 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 mars 2016
Senast verifierad
1 augusti 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1001156
- 2010-A01372-37 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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