Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

Bipolar Affective Disorder Clinical Trial

Official title:

Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249857
• Other study ID #: 1708056
• Secondary ID: 2017-A00917-46
• Status: Completed
• Phase: N/A
• Start date: October 26, 2017
• Est. completion date: August 21, 2018

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 21, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Disease
• Genetic Diseases, X-Linked
• Mood Disorders

Intervention

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)
• 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).

Locations

Country	Name	City	State
France	Chu Saint-Etienne	St Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response time for avoidance and affordance task	Comparison of response time for avoidance and affordance task between patients and healthy volunteers.	Months 24
Secondary	response time for affordance task	Comparison of response time for affordance task between patients and healthy volunteers.	Months 24
Secondary	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
Secondary	response time and cognitive tests	Correlation between response time and cognitive tests of patients and healthy volunteers.	Months 24