Clinical trial NCT03249857: Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
Official title: Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Affective Disorder
Keywords: Bipolar affective disorders
Cognition
Emotion
Embodiment
Sensorimotor
Simulation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: response time for avoidance and affordance task
timeFrame: Months 24
Secondary outcomes:
measure: response time for affordance task
timeFrame: Months 24
measure: correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms
timeFrame: Months 24
measure: response time and cognitive tests
timeFrame: Months 24
Other outcomes:
Locations:
city: St Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Catherine MASSOUBRE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: