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Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

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ClinicalTrials.gov Identifier: NCT03249857
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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).

Condition or disease Intervention/treatment Phase
Bipolar Affective Disorder Behavioral: cognitive tasks + IQ + MINI Behavioral: cognitive tasks Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. response time for avoidance and affordance task [ Time Frame: Months 24 ]
    Comparison of response time for avoidance and affordance task between patients and healthy volunteers.


Secondary Outcome Measures :
  1. response time for affordance task [ Time Frame: Months 24 ]
    Comparison of response time for affordance task between patients and healthy volunteers.

  2. correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms [ Time Frame: Months 24 ]
    These informations were collected of the medical file.

  3. response time and cognitive tests [ Time Frame: Months 24 ]
    Correlation between response time and cognitive tests of patients and healthy volunteers.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249857


Contacts
Contact: Anne GROSSELIN, neuropychologue (33)477127743 anne.grosselin@chu-st-etienne.fr
Contact: Anne GROSSELIN, neuropychologue anne.grosselin@chu-st-etienne.fr

Locations
France
Chu Saint-Etienne Recruiting
St Etienne, France, 42055
Contact: Catherine MASSOUBRE, MD    (0)477127962 ext +33    catherine.massoubre@chu-st-etienne.fr   
Principal Investigator: Catherine MASSOUBRE, MD PhD         
Sub-Investigator: Tania FERRAGUT, MD         
Sub-Investigator: Amandine BORDRON, MD         
Sub-Investigator: Marie-Christine OUVRY, MD         
Sub-Investigator: Nathalie VIALLON, MD         
Sub-Investigator: Stephane BOYER, MD         
Sub-Investigator: Torrance SIGAUD, MD         
Sub-Investigator: Aurélia GAY, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Catherine MASSOUBRE, MD PhD CHU SAINT-ETIENNE

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03249857     History of Changes
Other Study ID Numbers: 1708056
2017-A00917-46 ( Other Identifier: ANSM )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Bipolar affective disorders
Cognition
Emotion
Embodiment
Sensorimotor
Simulation

Additional relevant MeSH terms:
Disease
Mood Disorders
Bipolar Disorder
Genetic Diseases, X-Linked
Pathologic Processes
Mental Disorders
Bipolar and Related Disorders
Genetic Diseases, Inborn