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Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

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ClinicalTrials.gov Identifier: NCT03249857
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE August 10, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE October 26, 2017
Actual Primary Completion Date August 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • response time for affordance task [ Time Frame: Months 24 ]
    Comparison of response time for affordance task between patients and healthy volunteers.
  • 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.
  • response time and cognitive tests [ Time Frame: Months 24 ]
    Correlation between response time and cognitive tests of patients and healthy volunteers.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
Official Title  ICMJE Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Bipolar Affective Disorder
Intervention  ICMJE
  • 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)
  • 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).
Study Arms  ICMJE
  • Experimental: patients
    Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task
    Intervention: Behavioral: cognitive tasks + IQ + MINI
  • Active Comparator: control group
    Healthy volunteers (Control group) who will perform cognitive tasks + experimental task
    Intervention: Behavioral: cognitive tasks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
40
Actual Study Completion Date  ICMJE August 21, 2018
Actual Primary Completion Date August 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03249857
Other Study ID Numbers  ICMJE 1708056
2017-A00917-46 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine MASSOUBRE, MD PhD CHU SAINT-ETIENNE
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP