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Completed

NCT Number: NCT03249857

Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

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).

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Key information

Conditions

Bipolar Affective Disorder Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive tasks + IQ + MINI

Behavioral

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

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2017
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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