NCT02538445

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
Last Updated

March 23, 2016

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

August 31, 2015

Last Update Submit

March 22, 2016

Conditions

Keywords

SchizophreniaMemoryCognition

Outcome Measures

Primary Outcomes (1)

  • Number of items recalled TBR and TBF

    It is asked to the participants to recall orally, only TBR verbs (task of reminder). The experimenter notes the given verbs.

    Day 1

Secondary Outcomes (2)

  • Number of recognized items

    Day 1

  • Reaction time (ms) on the recognition of TBR and TBF

    Day 1

Study Arms (8)

Patients group 1

EXPERIMENTAL

Memorization of the verbs by miming the action

Other: Memorization of the verbs by miming the action

Patients group 2

EXPERIMENTAL

Memorization of the verbs by imagining the action

Other: Memorization of the verbs by imagining the action

Patients group 3

EXPERIMENTAL

Memorization of the action verbs by means of another word

Other: Memorization of the action verbs by means of another word

Patients group 4

EXPERIMENTAL

Simple memorization of the verbs

Other: Simple memorization of the verbs

Healthy volonteers group 1

ACTIVE COMPARATOR

Memorization of the verbs by miming the action

Other: Memorization of the verbs by miming the action

Healthy volonteers group 2

ACTIVE COMPARATOR

Memorization of the verbs by imagining the action

Other: Memorization of the verbs by imagining the action

Healthy volonteers group 3

ACTIVE COMPARATOR

Memorization of the action verbs by means of another word

Other: Memorization of the action verbs by means of another word

Healthy volonteers group 4

ACTIVE COMPARATOR

Simple memorization of the verbs

Other: Simple memorization of the verbs

Interventions

The participant reads aloud the verbs that appear on the screen, by performing the corresponding action verb.

Healthy volonteers group 1Patients group 1

The participant reads aloud the verbs that appear on the screen, by imagining the corresponding action verb.

Healthy volonteers group 2Patients group 2

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.

Healthy volonteers group 3Patients group 3

The participant reads aloud the verbs that appear on the screen, without additional instructions (control condition).

Healthy volonteers group 4Patients group 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Consent form signed
  • Affiliated to a Security Health Program

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Anne GROSSELIN, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 2, 2015

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 23, 2016

Record last verified: 2015-08

Data Sharing

IPD Sharing
Will not share

Locations