NCT02655172

Brief Summary

Brief Summary: In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible. However, automatic integration between perception and action is the necessary condition to be in "relationship with the world." Affordance is the experimental link between object perception and potentially associated actions (Gibson, 1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker \& Ellis sensory motor compatibility task (1998), with a modified response device (responses given with grasp), we study the impact of motor activation on these affordance effects. In this study, a group of controls will also be included in order to understand, as precisely as possible, the mechanisms involved (i.e., interference between the perception of the object and the response gesture).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 24, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

January 12, 2016

Last Update Submit

September 5, 2019

Conditions

Schizophrenic Disorders

Keywords

Schizophrenia, affordance,perception-action binding,stimulus-response-compatibility

Outcome Measures

Primary Outcomes (1)

  • response time

    The gain provided by the compatible vs incompatible conditions (ms response time)

    day 1

Study Arms (2)

Patients

EXPERIMENTAL

patients suffering schizophrenic disorders and who will perform cognitive tasks + PANSS+ IQ

Other: cognitive tasks + PANSS+ IQ

Control group

ACTIVE COMPARATOR

healthy patients who will perform cognitive tasks

Other: cognitive tasks

Interventions

cognitive tasks + PANSS+ IQOTHER

Patients will perform different tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield,1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale (Kay et al., 1987) + the experimental task (affordance task with graspable device)

Patients
cognitive tasksOTHER

Healthy volunteers will perform only Edinburgh laterality questionnaire (Oldfield, 1971) + the experimental task (affordance task with graspable device).

Control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For patients:
  • a DSM-IV diagnosis of schizophrenia (men or women),
  • no change in antipsychotic medication and clinical status within four weeks prior to the study
  • For patients and control group • Age ≥ 18 years et ≤ 55 years

You may not qualify if:

  • History of head trauma,
  • neurological disease with cerebral repercussion or not stabilized serious physical illness;
  • psychotropic medication
  • disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);
  • For patients:
  • IQ \< 70
  • For patients and control group
  • History of head trauma,
  • neurological disease with cerebral repercussion or not stabilized serious physical illness;
  • psychotropic medication
  • disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Anne GROSSELIN, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 13, 2016

Study Start

May 24, 2016

Primary Completion

April 3, 2019

Study Completion

April 3, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)