Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
- Conditions
- ApathyBehavioral Variant Frontotemporal Dementia (bvFTD)DisinhibitionDepression - Major Depressive Disorder
- Interventions
- Behavioral: ECOCAPTUREBehavioral: Cognitive and Behavioral experimental tasksDiagnostic Test: Neuropsychological assessmentBehavioral: ICM_APATHY_TASKSOther: MRIBiological: Neurohormonal mechanisms
- Registration Number
- NCT03272230
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Brief Summary
Apathy is defined as a quantitative reduction in voluntary and goal-directed behavior. To address this, the investigators propose an ethological approach to assess apathy objectively and quantitatively by observing patients in real-life situations.
The ECOCAPTURE paradigm involves a structured, multi-step scenario conducted in a functional exploration platform. This platform is equipped with an advanced data acquisition system integrating video recordings and sensors to precisely monitor and analyze participants' behavior.
Primary objective:
Develop a diagnostic tool for apathy using metrics derived from video recordings and sensor data. This tool aims to provide objective measures to identify and quantify apathy.
Secondary Objectives:
* Validation of ICM_APATHY_TASKS: This novel experimental task is designed to evaluate three primary mechanisms thought to underlie apathy: Motivation, Cognitive inertia (difficulty initiating tasks), The interaction between motivation and action execution.
* Identification of the pathophysiological mechanisms of apathy by investigate the cognitive, behavioral, neural, and neurohormonal underpinnings of apathy.
This will enable the classification of apathetic patients into subtypes (or several forms of apathy) based on the dominant mechanisms and provide insights into which processes best explain apathy in individual cases.
This innovative framework aims to deepen the understanding of apathy, improve diagnostic precision, and pave the way for tailored interventions.
- Detailed Description
A pilot study, ECOCAPTURE (ClinicalTrials.gov/NCT02496312, 2015), was conducted with participants diagnosed with the behavioral variant of frontotemporal dementia (bvFTD) matched for age, gender, and education level with healthy controls (n=7 per group). This study successfully validated the feasibility and conceptual framework of the ECOCAPTURE approach.
The aim of this trial is to further develop and expand the ECOCAPTURE tool by applying it to a larger population, including individuals with the behavioral variant of frontotemporal dementia (bvFTD) and healthy control participants.
The objectives of this study are to evaluate goal-directed behavior and identify apathy by analyzing data to establish a behavioral signature of apathy. Additionally, the study seeks to refine patient profiles by delineating the pathophysiological mechanisms underlying apathy, including cognitive processes, neural substrates, and neurohormonal pathways.
The experiments take place on an experimental platform dedicated to the functional exploration of human behavior (PRISME, ICM core facility, Salpêtrière Hospital, Paris, France), to assess behavior under ecological conditions. The ECOCAPTURE paradigm mimics a naturalistic situation (i.e., waiting comfortably in a waiting room). Participants undergo a structured 45-minute controlled scenario, during which their behavior is systematically monitored to evaluate apathy and disinhibition.
The PRISME platform is transformed into a furnished waiting room containing specific objects that provides opportunities to interact with the environment. The platform is equipped with a six-ceiling camera system (not hidden) covering the entire waiting room. The Media Recorder® software (NOLDUS Information Technology, Wageningen, the Netherlands) facilitates simultaneous video recordings from multiple cameras, ensuring synchronized capture across different viewpoints for comprehensive behavioral analysis. During the experiment, individuals' behavior is video-recorded, and their movement acceleration is measured using a wireless body sensor (Move II® triaxial accelerometer, Movisens GmbH, Karlsruhe, Germany) worn on the right hip. An eye-tracking system (SMI Eye Tracking Glasses 2 Wireless, ®SensoMotoric Instruments, Teltow, Germany / Tobii Pro Glasses 3, ®Tobii AB, Danderyd, Sweden) is added to the multimodal recording system, and the subjects wear eye-tracking glasses for a 7-minute period during the 45-minute experimental session. The subjects are informed at the time of initial consent that their behavior would be tracked and recorded by video cameras located in the room.
Video data analysis is performed with The Observer XT software (Version 14.0, NOLDUS, Wageningen, The Netherlands) to identify the frequency and duration of behaviors. Behavioral metrics are obtained by behavioral coding from 45-minute video footage for each individual. Behavioral coding data is collected through the continuous sampling method, to identify all occurrences of behaviors and their duration. Behavioral coding is conducted based on two ethograms - the ECOCAPTURE apathy ethogram, the ECOCAPTURE disinhibition ethogram - (Batrancourt et al. 2022, "The ECOCAPTURE ethograms: apathy ethogram and disinhibition ethogram", Mendeley Data, V2, doi: 10.17632/mv8hndcd95.2) The ECOCAPTURE apathy ethogram includes behaviors divided in two behavioral categories: Motor patterns, Activity states. The ECOCAPTURE disinhibition ethogram includes behaviors divided in three disinhibition categories: Compulsivity, Impulsivity, Social disinhibition.
Metrics built from collected data (video, sensors) are analyzed to reveal a behavioral signature of apathy.
The study consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Eligibility Criteria for All Groups:
- Demonstrates the ability to provide informed consent for participation in the study.
- Capable of understanding study instructions and performing cognitive tasks as required.
- Enrolled in a valid health insurance plan.
Eligibility Criteria for Patients:
- Mini-Mental State Examination (MMSE): Score ≥ 17.
- Medical History: Absence of any other neurological or psychiatric conditions.
- Caregiver Requirement: Must have a caregiver present.
Patient Groups:
- Diagnosed with behavioral variant frontotemporal dementia (bvFTD) based on the Rascovsky criteria (Rascovsky et al., 2011).
- Diagnosed with Major Depressive Disorder (MDD) according to DSM-IV criteria.
Eligibility Criteria for Healthy Age-, Sex-, and Education-Matched Controls:
- Mini-Mental State Examination (MMSE): Score > 27.
- Medical History: No history of neurological or psychiatric disorders.
- MRI Contraindications: Standard contraindications to magnetic resonance imaging (e.g., pacemaker, metallic implants, claustrophobia).
- Cognitive Barriers: Inability to comprehend study instructions.
- Legal Restrictions: Individuals referenced in Articles L.1121-5 to L.1121-8 and L.1122-12 of the French Public Health Code.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 ICM_APATHY_TASKS The Arm consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection. Arm 1 ECOCAPTURE The Arm consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection. Arm 1 Cognitive and Behavioral experimental tasks The Arm consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection. Arm 1 Neuropsychological assessment The Arm consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection. Arm 1 MRI The Arm consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection. Arm 1 Neurohormonal mechanisms The Arm consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection.
- Primary Outcome Measures
Name Time Method Frequency of each behavior in the ECOCAPTURE ethogram 45 min \[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer.
.Occurrence of each behavior in the ECOCAPTURE ethogram 45 min \[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer.
.Duration of each behavior in the ECOCAPTURE ethogram 45 min \[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer.
.Activity classes 45 min \[Provided by the accelerometer sensor\] Activity class: Indicates the physical position of the subject (unknown position = 0, lying down = 1, sitting/standing = 2, vertical movement upwards = 4, fast movement = 5, vertical movement downwards = 6, walking = 7)
Body positions 45 min \[Provided by the accelerometer sensor\] Body position: Specifies the characteristics of the lying position (unknown position = 0, lying on the back = 1, lying on the left side = 2, lying on the stomach = 3, lying on the right side = 4, getting up = 5).
Steps 45 min \[Provided by the accelerometer sensor\] Counting steps.
Energy expenditure 45 min \[Provided by the accelerometer sensor\] Energy expenditure during activity phases. kcal.
MET 45 min \[Provided by the accelerometer sensor\] The Metabolic Equivalent of Task: MET level.
Acceleration intensity 45 min \[Provided by the accelerometer sensor\] g.
Pupil Diameter x,y 7 min \[Provided by the eye-tracking glasses\] mm, mm.
Ocular events 7 mn \[Provided by the eye-tracking glasses\] Saccades, Fixations and Blink frequency.
Gaze points 7 mn \[Provided by the eye-tracking glasses\] Individual records of the participant's gaze at any given moment
- Secondary Outcome Measures
Name Time Method Total Protein Blood sample collection - 30 mn Ionogram result \[Total protein\] g/L
CRP Blood sample collection - 30 mn Inflammatory result \[C-reactive protein\] mG/L
AST Blood sample collection - 30 mn Hepatic result \[Aspartate aminotransferase\] U/L
ALT Blood sample collection - 30 mn Hepatic result \[Alanine aminotransferase\] U/L
GGT Blood sample collection - 30 mn Hepatic result \[Gamma-glutamyltransferase\] U/L
Cholesterol Blood sample collection - 30 mn Lipidic result \[Total cholesterol\] mmol/L
Triglycerides Blood sample collection - 30 mn Lipidic result \[Triglycerides\] mmol/L
HDL cholesterol Blood sample collection - 30 mn Lipidic result \[High-density lipoprotein cholesterol\] mmol/L
LDL cholesterol Blood sample collection - 30 mn Lipidic result \[Low-density lipoprotein cholesterol\] mmol/L
Glycerol Blood sample collection - 30 mn Lipidic result \[Plasma glycerol concentration\] mmol/L
FFAs Blood sample collection - 30 mn Lipidic result \[Plasma free fatty acids\] mmol/L
TSH Blood sample collection - 30 mn Thyroid result \[Thyroid-stimulating hormone blood test\] mmol/L
Creatinine Blood sample collection - 30 mn Ionogram result \[Creatinine\] µmol/L
STARKSTEIN (SAS) 10 mn \[Part of the neuropsychological assessment - Starkstein Apathy Scale\] SAS global score
DAS 10 mn \[Part of the neuropsychological assessment\] - Dimensional Apathy Scale - DAS global score - DAS initiation score - DAS executive score - DAS emotional score.
ICM_APATHY_TASKS 1 hour ICM_APATHY_TASKS global score. \[The ICM_APATHY_TASKS test three main presumed mechanisms of apathy: lack of motivation, cognitive inertia, and the decoupling between motivation and action. These tasks integrate two orthogonal dimensions: 1/ The cognitive dimension: modulation of the level of cognitive strategy (to study cognitive inertia); 2/ The motivational dimension: modulation of the reward at stake (to study lack of motivation)\].
MMSE 5 mn \[Part of the neuropsychological assessment\] - Mini Mental State Exam - MMSE global score
MADRS 10 mn \[Part of the neuropsychological assessment\] - Montgomery-Åsberg Depression Rating Scale - MADRS global score
EBI 15 mn \[Part of the neuropsychological assessment\] - Eating Behavior Inventory - EBI scores. \[Food behavior questionnaire. This refers to an assessment tool designed to evaluate a person's eating behaviors and identify potential risks, such as choking or aspiration, during eating\].
MATTIS 20 mn \[Part of the neuropsychological assessment\] - Mattis Dementia Rating Scale - MATTIS global score
FAB 10 mn \[Part of the neuropsychological assessment\] - Frontal Assessment Battery - FAB global score \[French version: BREF\].
HAYLING 15 mn \[Part of the neuropsychological assessment\] - Hayling Sentence Completion test - HAYLING B-A score
HAD 10 mn \[Part of the neuropsychological assessment\] Hospital Anxiety and Depression Scale - HAD global score
STROOP 3 mn \[Part of the neuropsychological assessment\] - STROOP - STROOP global score
Mini-SEA 20 mn \[Part of the neuropsychological assessment\] - Mini Social cognition and Emotional Assesment - Mini-SEA global score
Verbal Span / Lexical verbal fluency 7 mn \[Part of the neuropsychological assessment\] - Verbal Span / Lexical verbal fluency - Verbal scores
CDRS 5 mn \[Part of the neuropsychological assessment\] - Clinical Dementia Rating (CDR) Scale - CDRS global score
Gray matter volume MRI exam: 48 mn \[MRI analysis- Brain segmentation\] mm3
White matter volume MRI exam: 48 mn \[MRI analysis- Brain segmentation\] mm3
Cortical Thickness MRI exam: 48 mn \[MRI analysis- Brain segmentation\] mm
Resting-State Connectivity MRI exam: 48 mn \[fMRI analysis\] - strength and significance of the connection between different regions.
IL-6 Blood sample collection - 30 mn Hormonal result \[Interleukin-6\] pg/mL
Leptin Blood sample collection - 30 mn Hormonal result \[Leptin\] ng/mL
Adiponectin Blood sample collection - 30 mn Hormonal result \[Blood adiponectin level)\] mg/L
Insulin Blood sample collection - 30 mn Hormonal result \[Fasting Insulin\] mUI/L
C-Peptide Blood sample collection - 30 mn Diabetic result \[Fasting C-Peptide level\] µg/L
FPG Blood sample collection - 30 mn Diabetic result \[Fasting Plasma Glucose\] mmol/L
HbA1C Blood sample collection - 30 mn Diabetic result \[Glycated Hemoglobin\] %
Sodium Blood sample collection - 30 mn Ionogram result \[Sodium\] mmol/L
K+ Blood sample collection - 30 mn Ionogram result \[Potassium\] mmol/L
Uric acid Blood sample collection - 30 mn Ionogram result \[Uric acid\] µmol/L
Trial Locations
- Locations (1)
Paris Brain Institute / ICM / Pitié-Salpêtrière Hospital AP-HP / CIC
🇫🇷Paris, France