NCT03249857

Brief Summary

Based in an embodied approach of cognition, several studies have highlighted a direct link between perception of an object or an emotion and the associated motor responses. This study investigated in patients suffering from bipolar affective disorders whether the perception of emotional words involves an automatic sensorimotor simulation of approach and avoidance behaviors, and whether the perception of an object involves an automatic sensorimotor simulation of object prehension (affordance). We hypothesize that, in this pathology, low level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will be recruited. The main objective is the emergence of sensorimotor compatibility effects in approach-avoidance task with emotional stimuli (gain between compatible vs incompatible conditions).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 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

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 26, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2018

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

August 10, 2017

Last Update Submit

January 7, 2020

Conditions

Keywords

Bipolar affective disordersCognitionEmotionEmbodimentSensorimotorSimulation

Outcome Measures

Primary Outcomes (1)

  • response time for avoidance and affordance task

    Comparison of response time for avoidance and affordance task between patients and healthy volunteers.

    Months 24

Secondary Outcomes (3)

  • response time for affordance task

    Months 24

  • correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms

    Months 24

  • response time and cognitive tests

    Months 24

Study Arms (2)

patients

EXPERIMENTAL

Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task

Behavioral: cognitive tasks + IQ + MINI

control group

ACTIVE COMPARATOR

Healthy volunteers (Control group) who will perform cognitive tasks + experimental task

Behavioral: cognitive tasks

Interventions

Patients will perform different tasks: * cognitive tasks : reaction time (Alert TEA, Zimmermann and Fimm, 2005) + Edinburgh laterality questionnaire (Oldfield,1971) + hamilton and young's scale (Tohen et al., 2009) + Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) + experimental task (approach/ avoidance and affordance task). * Intelligence Quotient (IQ) test (PM38, Raven, 1960) * Mini International Neuropsychiatric Interview (MINI, Van Vliet et al., 2006)

patients
cognitive tasksBEHAVIORAL

Healthy volunteers will perform only the cognitive tasks = reaction time alert TEA, Zimmermann and Fimm, 2005 + Edinburgh laterality questionnaire (Oldfield, 1971) + experimental task (approach/ avoidance and affordance task).

control group

Eligibility Criteria

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

You may qualify if:

  • For patients:
  • Affiliated or entitled to a social security
  • Aged between 18 and 55
  • Patients of both sexes suffering from bipolar disorders (DSM V criteria) whatever the subtype
  • Stabilized from a point of view clinical and therapeutic
  • Euthymic (score \<7 at the Hamilton scale, and score \<8 at Young's scale)
  • Must have given their informed consent before their participation in the study
  • Be right-handed (score\> 14 on the laterality scale)
  • For control group:
  • Affiliated or entitled to a social security
  • Must have given their informed consent before their participation in the study
  • Be right-handed (score\> 14 on the lateral scale)
  • Aged 18 to 55 matched by age (± 5 years), sex, and on the study level of patients (years of schooling after primary school ± 2 years)

You may not qualify if:

  • For patients:
  • Thymic acute decompensation
  • Hamilton scale \> 8, Young's scale \> 9
  • Montreal Cognitive Assessment (MOCA) \<26
  • History neurological pathology with cerebral impairment or serious somatic disease
  • Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal) within 6 months.
  • IQ \< 70
  • History of head trauma
  • For control group:
  • History of head trauma
  • Neurological pathology with cerebral impairment or serious somatic disease
  • Psychotropic treatment
  • Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal)
  • IQ \< 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Catherine MASSOUBRE, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 15, 2017

Study Start

October 26, 2017

Primary Completion

August 21, 2018

Study Completion

August 21, 2018

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations