Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

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).

Study Overview

• Status: Completed
• Conditions: Bipolar Affective Disorder
• Intervention / Treatment: Behavioral: cognitive tasks + IQ + MINI; Behavioral: cognitive tasks

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • St Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: patients; Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task	Behavioral: cognitive tasks + IQ + MINI; 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)
ACTIVE_COMPARATOR: control group; Healthy volunteers (Control group) who will perform cognitive tasks + experimental task	Behavioral: cognitive tasks; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response time for avoidance and affordance task	Comparison of response time for avoidance and affordance task between patients and healthy volunteers.	Months 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response time for affordance task	Comparison of response time for affordance task between patients and healthy volunteers.	Months 24
correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms	These informations were collected of the medical file.	Months 24
response time and cognitive tests	Correlation between response time and cognitive tests of patients and healthy volunteers.	Months 24

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Catherine MASSOUBRE, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 26, 2017
• Primary Completion (ACTUAL): August 21, 2018
• Study Completion (ACTUAL): August 21, 2018

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (ACTUAL): August 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Emotion; Cognition; Simulation; Embodiment; Sensorimotor; Bipolar affective disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Genetic Diseases, Inborn; Bipolar and Related Disorders; Disease; Bipolar Disorder; Mood Disorders; Genetic Diseases, X-Linked
• Other Study ID Numbers: 1708056; 2017-A00917-46 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No