Social-cognitive Functioning: Validation of a New Neuropsychological Test (REALSOCOG)
Primary Purpose
Alzheimer's Disease (AD), Lewy Body Dementia (LBD), Frontotemporal Degeneration (FTD)
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
REALSOCOG
BCS
Hetero-questionnaires
Sponsored by
About this trial
This is an interventional other trial for Alzheimer's Disease (AD) focused on measuring Neurodegenerative diseases, Social behavior, Social cognition, Neuropsychological assessment
Eligibility Criteria
Inclusion Criteria:
For patients:
- Patient aged between 18 and 90 years
- Mini Mental State Examination (MMSE) score greater than or equal to 20
- Patient able to express his or her non-opposition to participate in the study in an informed and autonomous manner
- Patient with a neurodegenerative pathology: FTD, AD or LBD.
For caregivers:
- Over 18 years of age
- Regular contact with the patient (≥ 2 times per month)
Exclusion Criteria:
For patients:
- Neurological or psychiatric comorbidity
- Notable sensory disorders (e.g., profound or total deafness, age-related macular degeneration, blindness, etc.) that may interfere with experimental completion.
- Opposition to participation in the study
Sites / Locations
- Hôpital de la Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Patients
Relatives
Arm Description
Patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL) or fronto-temporal lobar degeneration (FTD))
Caregivers or relatives of included patients, having regular contact with the patient (≥ 2 times per month).
Outcomes
Primary Outcome Measures
rate of inappropriate behavioural intentions
It is measured by the REALSoCog task through a question asking the participant to specify his behavioral intention in the case where he would have declared his intention to act in front of the social situation presented. These questions are asked for each social situation presented, i.e. for a total of 16 situations
Secondary Outcome Measures
Assessment of Moral cognition
The ability to detect moral transgressions, the ability to detect conventional transgressions, and the ability to detect control situations (non-transgressive situations) are measured by the question "Does this situation seem appropriate or inappropriate to you?" asked after each REALSoCog situation. The severity judgment of moral transgressions and the severity judgment of conventional transgressions are measured by the question "How inappropriate does it [the situation] seem to you?" asked after each response characterizing the situation presented as inappropriate in REALSoCog.
Evaluation of Empathy and emotional reactivity
The intensity of emotional empathy and the intensity of emotional reactivity are measured by the question "How much are you affected by the situation? This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.
The valence and congruence of the emotions felt are measured by the question "The emotion you feel at the sight of this situation is: 1 (very negative) to 5 (very positive)". This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.
Assessment of theory of mind
The ability to detect the intentionality of an action is measured by the question "Is the behavior of the [main protagonist in the situation] intentional? Yes / No". This question is asked for 5 REALSoCog situations.
The ability to characterize the valence of this intention and the average valence of the attributed intentions is measured by the question "In your opinion the intention is: 1 (very malicious) to 5 (very benevolent)". This question is asked for 5 REALSoCog situations.
The ability to infer an affect to others is measured by the question "How does [main protagonist of the situation] feel?". This question is asked for 8 REALSoCog situations.
The intensity of the affect attributed to others is measured by the question "How does [main protagonist of the situation] feel about [subject's response to the previous question]?" This question is asked for 8 REALSoCog situations.
Full Information
NCT ID
NCT05558709
First Posted
September 20, 2022
Last Updated
May 22, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05558709
Brief Title
Social-cognitive Functioning: Validation of a New Neuropsychological Test
Acronym
REALSOCOG
Official Title
Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
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
It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).
Detailed Description
It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (AD), Lewy Body Dementia (LBD), Frontotemporal Degeneration (FTD)
Keywords
Neurodegenerative diseases, Social behavior, Social cognition, Neuropsychological assessment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL) or fronto-temporal lobar degeneration (FTD))
Arm Title
Relatives
Arm Type
Other
Arm Description
Caregivers or relatives of included patients, having regular contact with the patient (≥ 2 times per month).
Intervention Type
Other
Intervention Name(s)
REALSOCOG
Other Intervention Name(s)
neuropsychological test
Intervention Description
Patients will be asked to perform the REALSoCog serious game-type social cognition assessment task developed by the LMC2 laboratory (UR 7536). Their performance will be compared to those of control individuals recruited in parallel (independant clinical study: CER-U, IRB N°: 00012020-115). Participants will be asked to think about 16 social situations (6 control situations and 10 experimental situations) encountered in a virtual environment representing a city. REALSoCog can be used on a laptop computer, without any additional technical device.
Intervention Type
Other
Intervention Name(s)
BCS
Other Intervention Name(s)
Social-Cognition Battery
Intervention Description
Social-cognitive tasks from the BCS (Ehrlé et al., 2011) will also be offered to patients to test the concurrent validity of REALSoCog. This battery assesses social cognition. It includes paper-and-pencil tasks.
Intervention Type
Other
Intervention Name(s)
Hetero-questionnaires
Intervention Description
Hetero-questionnaires assessing patients' social behavior will be transmitted to their relative or primary caregiver (Godefroy & le GREFEX, 2008; Gury and Ehrlé, in progress of validation) in order to verify the concurrent validity of REALSoCog. These hetero-questionnaires aim to identify and quantify the presence of social skills and behaviour disorders.
Primary Outcome Measure Information:
Title
rate of inappropriate behavioural intentions
Description
It is measured by the REALSoCog task through a question asking the participant to specify his behavioral intention in the case where he would have declared his intention to act in front of the social situation presented. These questions are asked for each social situation presented, i.e. for a total of 16 situations
Time Frame
1 hour and a half
Secondary Outcome Measure Information:
Title
Assessment of Moral cognition
Description
The ability to detect moral transgressions, the ability to detect conventional transgressions, and the ability to detect control situations (non-transgressive situations) are measured by the question "Does this situation seem appropriate or inappropriate to you?" asked after each REALSoCog situation. The severity judgment of moral transgressions and the severity judgment of conventional transgressions are measured by the question "How inappropriate does it [the situation] seem to you?" asked after each response characterizing the situation presented as inappropriate in REALSoCog.
Time Frame
1 hour and a half
Title
Evaluation of Empathy and emotional reactivity
Description
The intensity of emotional empathy and the intensity of emotional reactivity are measured by the question "How much are you affected by the situation? This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.
The valence and congruence of the emotions felt are measured by the question "The emotion you feel at the sight of this situation is: 1 (very negative) to 5 (very positive)". This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.
Time Frame
1 hour and a half
Title
Assessment of theory of mind
Description
The ability to detect the intentionality of an action is measured by the question "Is the behavior of the [main protagonist in the situation] intentional? Yes / No". This question is asked for 5 REALSoCog situations.
The ability to characterize the valence of this intention and the average valence of the attributed intentions is measured by the question "In your opinion the intention is: 1 (very malicious) to 5 (very benevolent)". This question is asked for 5 REALSoCog situations.
The ability to infer an affect to others is measured by the question "How does [main protagonist of the situation] feel?". This question is asked for 8 REALSoCog situations.
The intensity of the affect attributed to others is measured by the question "How does [main protagonist of the situation] feel about [subject's response to the previous question]?" This question is asked for 8 REALSoCog situations.
Time Frame
1 hour and a half
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For patients:
Patient aged between 18 and 90 years
Mini Mental State Examination (MMSE) score greater than or equal to 20
Patient able to express his or her non-opposition to participate in the study in an informed and autonomous manner
Patient with a neurodegenerative pathology: FTD, AD or LBD.
For caregivers:
Over 18 years of age
Regular contact with the patient (≥ 2 times per month)
Exclusion Criteria:
For patients:
Neurological or psychiatric comorbidity
Notable sensory disorders (e.g., profound or total deafness, age-related macular degeneration, blindness, etc.) that may interfere with experimental completion.
Opposition to participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc VERNY, Pr
Phone
01 42 16 03 12
Ext
+33
Email
marc.verny@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline NARME
Phone
06 08 98 38 04
Ext
+33
Email
paulinenarme@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc VERNY, Pr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc VERNY, Pr
Phone
01 42 16 03 12
Ext
+33
Email
marc.verny@aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Social-cognitive Functioning: Validation of a New Neuropsychological Test
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