Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
2 other identifiers
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2018
CompletedJanuary 9, 2020
January 1, 2020
10 months
August 10, 2017
January 7, 2020
Conditions
Keywords
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
EXPERIMENTALPatients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task
control group
ACTIVE COMPARATORHealthy volunteers (Control group) who will perform cognitive tasks + experimental task
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)
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).
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine MASSOUBRE, MD PhD
CHU SAINT-ETIENNE
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