- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02538445
Can we Forget? Directed Forgetting and Embodied Cognition in Schizophrenia
22. März 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
96
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
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Saint Etienne, Frankreich, 42000
- Chu de Saint-Etienne
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 50 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: Patients group 3
Memorization of the action verbs by means of another word
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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.
|
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Experimental: Patients group 4
Simple memorization of the verbs
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The participant reads aloud the verbs that appear on the screen, without additional instructions (control condition).
|
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Aktiver 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.
|
|
Aktiver 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.
|
|
Aktiver 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.
|
|
Aktiver 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).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of items recalled TBR and TBF
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of recognized items
Zeitfenster: 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
Zeitfenster: Day 1
|
The response times of participants are recorded in ms.
|
Day 1
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Anne GROSSELIN, MD, Chu de Saint-Etienne
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2011
Primärer Abschluss (Tatsächlich)
1. Dezember 2012
Studienabschluss (Tatsächlich)
1. Dezember 2012
Studienanmeldedaten
Zuerst eingereicht
31. August 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. August 2015
Zuerst gepostet (Schätzen)
2. September 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
23. März 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. März 2016
Zuletzt verifiziert
1. August 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1001156
- 2010-A01372-37 (Andere Kennung: ANSM)
Plan für individuelle Teilnehmerdaten (IPD)
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