search
Back to results

Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

Primary Purpose

Bipolar Affective Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive tasks + IQ + MINI
cognitive tasks
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bipolar Affective Disorder focused on measuring Bipolar affective disorders, Cognition, Emotion, Embodiment, Sensorimotor, Simulation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients

control group

Arm Description

Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task

Healthy volunteers (Control group) who will perform cognitive tasks + experimental task

Outcomes

Primary Outcome Measures

response time for avoidance and affordance task
Comparison of response time for avoidance and affordance task between patients and healthy volunteers.

Secondary Outcome Measures

response time for affordance task
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
These informations were collected of the medical file.
response time and cognitive tests
Correlation between response time and cognitive tests of patients and healthy volunteers.

Full Information

First Posted
August 10, 2017
Last Updated
January 7, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT03249857
Brief Title
Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
Official Title
Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Affective Disorder
Keywords
Bipolar affective disorders, Cognition, Emotion, Embodiment, Sensorimotor, Simulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Healthy volunteers (Control group) who will perform cognitive tasks + experimental task
Intervention Type
Behavioral
Intervention Name(s)
cognitive tasks + IQ + MINI
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
cognitive tasks
Intervention Description
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 Measure Information:
Title
response time for avoidance and affordance task
Description
Comparison of response time for avoidance and affordance task between patients and healthy volunteers.
Time Frame
Months 24
Secondary Outcome Measure Information:
Title
response time for affordance task
Description
Comparison of response time for affordance task between patients and healthy volunteers.
Time Frame
Months 24
Title
correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms
Description
These informations were collected of the medical file.
Time Frame
Months 24
Title
response time and cognitive tests
Description
Correlation between response time and cognitive tests of patients and healthy volunteers.
Time Frame
Months 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine MASSOUBRE, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
St Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

We'll reach out to this number within 24 hrs