Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System (ECOCAPTURE)

Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease

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.

Study Overview

• Status: Completed
• Conditions: Apathy; Behavioral Variant Frontotemporal Dementia (bvFTD); Depression - Major Depressive Disorder; Disinhibition
• Intervention / Treatment: Behavioral: ECOCAPTURE; Behavioral: Cognitive and Behavioral experimental tasks; Behavioral: ICM_APATHY_TASKS; Biological: Neurohormonal mechanisms; Diagnostic test: Neuropsychological assessment; Other: MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Paris Brain Institute / ICM / Pitié-Salpêtrière Hospital AP-HP / CIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy volunteers	Behavioral: ECOCAPTURE; 45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system; Behavioral: Cognitive and Behavioral experimental tasks; Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions; Behavioral: ICM_APATHY_TASKS; Apathy experimental task; Biological: Neurohormonal mechanisms; Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage; Diagnostic test: Neuropsychological assessment; STARKSTEIN APATHY SCALE (SAS) / DAS / MMSE / MADRS / EBI / MINI-SEA / FAB / HAD / MATTIS / HAYLING / STROOP / Verbal Span / Lexical verbal fluency / TMT / CDRS; Other: MRI; T1 / T2 / rs-fMRI / MS-DWI
Experimental: Arm 1; 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.	Behavioral: ECOCAPTURE; 45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system; Behavioral: Cognitive and Behavioral experimental tasks; Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions; Behavioral: ICM_APATHY_TASKS; Apathy experimental task; Biological: Neurohormonal mechanisms; Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage; Diagnostic test: Neuropsychological assessment; STARKSTEIN APATHY SCALE (SAS) / DAS / MMSE / MADRS / EBI / MINI-SEA / FAB / HAD / MATTIS / HAYLING / STROOP / Verbal Span / Lexical verbal fluency / TMT / CDRS; Other: MRI; T1 / T2 / rs-fMRI / MS-DWI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of each behavior in the ECOCAPTURE ethogram	[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. .	45 minutes
Occurrence of each behavior in the ECOCAPTURE ethogram	[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. .	45 minutes
Duration of each behavior in the ECOCAPTURE ethogram	[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. .	45 minutes
Activity classes	[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)	45 minutes
Body positions	[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).	45 minutes
Steps	[Provided by the accelerometer sensor] Counting steps.	45 minutes
Energy expenditure	[Provided by the accelerometer sensor] Energy expenditure during activity phases. kcal.	45 minutes
MET	[Provided by the accelerometer sensor] The Metabolic Equivalent of Task: MET level.	45 minutes
Acceleration intensity	[Provided by the accelerometer sensor] g.	45 minutes
Pupil Diameter x,y	[Provided by the eye-tracking glasses] mm, mm.	7 minutes
Ocular events	[Provided by the eye-tracking glasses] Saccades, Fixations and Blink frequency.	7 minutes
Gaze points	[Provided by the eye-tracking glasses] Individual records of the participant's gaze at any given moment	7 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STARKSTEIN (SAS)	[Part of the neuropsychological assessment - Starkstein Apathy Scale] SAS global score	10 minutes
DAS	[Part of the neuropsychological assessment] - Dimensional Apathy Scale - DAS global score - DAS initiation score - DAS executive score - DAS emotional score.	10 minutes
ICM_APATHY_TASKS	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)].	60 minutes
MMSE	[Part of the neuropsychological assessment] - Mini Mental State Exam - MMSE global score	5 minutes
MADRS	[Part of the neuropsychological assessment] - Montgomery-Åsberg Depression Rating Scale - MADRS global score	10 minutes
EBI	[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].	15 minutes
MATTIS	[Part of the neuropsychological assessment] - Mattis Dementia Rating Scale - MATTIS global score	20 minutes
FAB	[Part of the neuropsychological assessment] - Frontal Assessment Battery - FAB global score [French version: BREF].	10 minutes
HAYLING	[Part of the neuropsychological assessment] - Hayling Sentence Completion test - HAYLING B-A score	15 minutes
HAD	[Part of the neuropsychological assessment] Hospital Anxiety and Depression Scale - HAD global score	10 minutes
STROOP	[Part of the neuropsychological assessment] - STROOP - STROOP global score	3 minutes
Mini-SEA	[Part of the neuropsychological assessment] - Mini Social cognition and Emotional Assesment - Mini-SEA global score	20 minutes
Verbal Span / Lexical verbal fluency	[Part of the neuropsychological assessment] - Verbal Span / Lexical verbal fluency - Verbal scores	7 minutes
CDRS	[Part of the neuropsychological assessment] - Clinical Dementia Rating (CDR) Scale - CDRS global score	5 minutes
Gray matter volume	[MRI analysis- Brain segmentation] mm3	MRI exam: 48 minutes
White matter volume	[MRI analysis- Brain segmentation] mm3	MRI exam: 48 minutes
Cortical Thickness	[MRI analysis- Brain segmentation] mm	MRI exam: 48 minutes
Resting-State Connectivity	[fMRI analysis] - strength and significance of the connection between different regions.	MRI exam: 48 minutes
IL-6	Hormonal result [Interleukin-6] pg/mL	Blood sample collection - 30 minutes
Leptin	Hormonal result [Leptin] ng/mL	Blood sample collection - 30 minutes
Adiponectin	Hormonal result [Blood adiponectin level)] mg/L	Blood sample collection - 30 minutes
Insulin	Hormonal result [Fasting Insulin] mUI/L	Blood sample collection - 30 minutes
C-Peptide	Diabetic result [Fasting C-Peptide level] µg/L	Blood sample collection - 30 minutes
FPG	Diabetic result [Fasting Plasma Glucose] mmol/L	Blood sample collection - 30 minutes
HbA1C	Diabetic result [Glycated Hemoglobin] %	Blood sample collection - 30 minutes
Sodium	Ionogram result [Sodium] mmol/L	Blood sample collection - 30 minutes
K+	Ionogram result [Potassium] mmol/L	Blood sample collection - 30 minutes
Uric acid	Ionogram result [Uric acid] µmol/L	Blood sample collection - 30 minutes
Creatinine	Ionogram result [Creatinine] µmol/L	Blood sample collection - 30 minutes
Total Protein	Ionogram result [Total protein] g/L	Blood sample collection - 30 minutes
CRP	Inflammatory result [C-reactive protein] mG/L	Blood sample collection - 30 minutes
AST	Hepatic result [Aspartate aminotransferase] U/L	Blood sample collection - 30 minutes
ALT	Hepatic result [Alanine aminotransferase] U/L	Blood sample collection - 30 minutes
GGT	Hepatic result [Gamma-glutamyltransferase] U/L	Blood sample collection - 30 minutes
Cholesterol	Lipidic result [Total cholesterol] mmol/L	Blood sample collection - 30 minutes
Triglycerides	Lipidic result [Triglycerides] mmol/L	Blood sample collection - 30 minutes
HDL cholesterol	Lipidic result [High-density lipoprotein cholesterol] mmol/L	Blood sample collection - 30 minutes
LDL cholesterol	Lipidic result [Low-density lipoprotein cholesterol] mmol/L	Blood sample collection - 30 minutes
Glycerol	Lipidic result [Plasma glycerol concentration] mmol/L	Blood sample collection - 30 minutes
FFAs	Lipidic result [Plasma free fatty acids] mmol/L	Blood sample collection - 30 minutes
TSH	Thyroid result [Thyroid-stimulating hormone blood test] mmol/L	Blood sample collection - 30 minutes

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Groupe Hospitalier Pitie-Salpetriere; Institut du Cerveau et de la Moelle (ICM Institute)
• Investigators: Principal Investigator: Richard LEVY, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Chair: Bénédicte BATRANCOURT, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• Godefroy V, Tanguy D, Bouzigues A, Sezer I, Ferrand-Verdejo J, Azuar C, Bendetowicz D, Carle G, Rametti-Lacroux A, Bombois S, Cognat E, Jannin P, Morandi X, Ber IL, Levy R, Batrancourt B, Migliaccio R. Frontotemporal dementia subtypes based on behavioral inhibition deficits. Alzheimers Dement (Amst). 2021 Apr 6;13(1):e12178. doi: 10.1002/dad2.12178. eCollection 2021.
• Godefroy V, Batrancourt B, Charron S, Bouzigues A, Bendetowicz D, Carle G, Rametti-Lacroux A, Bombois S, Cognat E, Migliaccio R, Levy R. Functional connectivity correlates of reduced goal-directed behaviors in behavioural variant frontotemporal dementia. Brain Struct Funct. 2022 Dec;227(9):2971-2989. doi: 10.1007/s00429-022-02519-5. Epub 2022 Jun 25.
• Godefroy V, Batrancourt B, Charron S, Bouzigues A, Sezer I, Bendetowicz D, Carle G, Rametti-Lacroux A, Bombois S, Cognat E, Migliaccio R, Levy R. Disentangling Clinical Profiles of Apathy in Behavioral Variant Frontotemporal Dementia. J Alzheimers Dis. 2022;90(2):639-654. doi: 10.3233/JAD-220370.
• Godefroy V, Durand A, Simon MC, Weber B, Kable J, Lerman C, Bergstrom F, Levy R, Batrancourt B, Schmidt L, Plassmann H, Koban L. A structural MRI marker predicts individual differences in impulsivity and classifies patients with behavioral-variant frontotemporal dementia from matched controls. bioRxiv [Preprint]. 2024 Sep 16:2024.09.12.612706. doi: 10.1101/2024.09.12.612706.
• Batrancourt B, Lecouturier K, Ferrand-Verdejo J, Guillemot V, Azuar C, Bendetowicz D, Migliaccio R, Rametti-Lacroux A, Dubois B, Levy R. Exploration Deficits Under Ecological Conditions as a Marker of Apathy in Frontotemporal Dementia. Front Neurol. 2019 Aug 28;10:941. doi: 10.3389/fneur.2019.00941. eCollection 2019.
• Peltier C, Lejeune FX, Jorgensen LGT, Rametti-Lacroux A, Tanguy D, Godefroy V, Bendetowicz D, Carle G, Cognat E, Bombois S, Migliaccio R, Levy R, Marin F, Batrancourt B; ECOCAPTURE study group. A temporal classification method based on behavior time series data in patients with behavioral variant of frontotemporal dementia and apathy. J Neurosci Methods. 2022 Jul 1;376:109625. doi: 10.1016/j.jneumeth.2022.109625. Epub 2022 May 30.
• Tanguy D, Batrancourt B, Estudillo-Romero A, Baxter JSH, Le Ber I, Bouzigues A, Godefroy V, Funkiewiez A, Chamayou C, Volle E, Saracino D, Rametti-Lacroux A, Morandi X, Jannin P, Levy R, Migliaccio R; ECOCAPTURE study group. An ecological approach to identify distinct neural correlates of disinhibition in frontotemporal dementia. Neuroimage Clin. 2022;35:103079. doi: 10.1016/j.nicl.2022.103079. Epub 2022 Jun 7.
• Tanguy D, Rametti-Lacroux A, Bouzigues A, Saracino D, Le Ber I, Godefroy V, Morandi X, Jannin P, Levy R, Batrancourt B, Migliaccio R; ECOCAPTURE Study Group. Behavioural disinhibition in frontotemporal dementia investigated within an ecological framework. Cortex. 2023 Mar;160:152-166. doi: 10.1016/j.cortex.2022.11.013. Epub 2022 Dec 28.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Assessment; Dementia; Diagnosis; Accelerometer; Apathy; Sensor; Disinhibition; Goal-directed behavior; Neurological disease; Ecological condition; Human ethology; Behavioral sensing; ECOCAPTURE
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Mental Disorders; Pathologic Processes; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease; Dementia; Nervous System Diseases; Lethargy
• Other Study ID Numbers: C16-87; 2017-A00416-47 (Registry Identifier: RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The scientific leaders of the ECOCAPTURE research project aim to participate in international OPEN DATA initiatives. In this context, the following fully anonymized data will be made available to the scientific community:

• Data collected from the accelerometer-type sensor.
• Data on the subject's ocular behavior (events such as saccades or fixations) from the eye-tracking sensor. The videos from the glasses will not be shared.
• Behavioral data from video coding based on the ECOCAPTURE ethogram. The videos will not be shared.
• Scores from the neuropsychological assessment
• MRI data
• Blood test data.

• IPD Sharing Time Frame: 2026-2030
• IPD Sharing Access Criteria: Researchers must contact the scientific leaders of the study, and an agreement must be established with the sponsor (INSERM).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Study Data/Documents

1. Study Protocol
   Information comments: The ECOCAPTURE ethograms: apathy ethogram and disinhibition ethogram
2. Individual Participant Data Set
   Information comments: ECOCAPTURE Dataset - Behavioral coding from video - 17 bvFTD and 18 HC - 28.04.2022
3. Individual Participant Data Set
   Information comments: ECOCAPTURE Dataset - Behavioral coding from video - 20 bvFTD and 18 HC - 21.03.2022
4. Individual Participant Data Set
   Information comments: ECOCAPTURE Dataset - Behavioral coding from video - 23 bvFTD and 24 HC - 28.11.2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No