An interventional study of ECOCAPTURE and Cognitive and Behavioral experimental tasks in Apathy, Behavioral Variant Frontotemporal Dementia (bvFTD) and Disinhibition, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Diagnostic
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:
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.
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.
Eligibility Criteria for All Groups:
Eligibility Criteria for Patients:
Patient Groups:
Eligibility Criteria for Healthy Age-, Sex-, and Education-Matched Controls:
Exclusion Criteria:
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 · Behavioral: Cognitive and Behavioral experimental tasks · Diagnostic Test: Neuropsychological assessment · Behavioral: ICM_APATHY_TASKS · Other: MRI · Biological: Neurohormonal mechanisms
Behavioral: ECOCAPTURE · Behavioral: Cognitive and Behavioral experimental tasks · Diagnostic Test: Neuropsychological assessment · Behavioral: ICM_APATHY_TASKS · Other: MRI · Biological: Neurohormonal mechanisms
45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system
Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions
STARKSTEIN APATHY SCALE (SAS) / DAS / MMSE / MADRS / EBI / MINI-SEA / FAB / HAD / MATTIS / HAYLING / STROOP / Verbal Span / Lexical verbal fluency / TMT / CDRS
Apathy experimental task
T1 / T2 / rs-fMRI / MS-DWI
Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
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. .
Time frame: 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. .
Time frame: 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. .
Time frame: 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)
Time frame: 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).
Time frame: 45 minutes
Steps
\[Provided by the accelerometer sensor\] Counting steps.
Time frame: 45 minutes
Energy expenditure
\[Provided by the accelerometer sensor\] Energy expenditure during activity phases. kcal.
Time frame: 45 minutes
MET
\[Provided by the accelerometer sensor\] The Metabolic Equivalent of Task: MET level.
Time frame: 45 minutes
Acceleration intensity
\[Provided by the accelerometer sensor\] g.
Time frame: 45 minutes
Pupil Diameter x,y
\[Provided by the eye-tracking glasses\] mm, mm.
Time frame: 7 minutes
Ocular events
\[Provided by the eye-tracking glasses\] Saccades, Fixations and Blink frequency.
Time frame: 7 minutes
Gaze points
\[Provided by the eye-tracking glasses\] Individual records of the participant's gaze at any given moment
Time frame: 7 minutes
STARKSTEIN (SAS)
\[Part of the neuropsychological assessment - Starkstein Apathy Scale\] SAS global score
Time frame: 10 minutes
DAS
\[Part of the neuropsychological assessment\] - Dimensional Apathy Scale - DAS global score - DAS initiation score - DAS executive score - DAS emotional score.
Time frame: 10 minutes
ICM_APATHY_TASKS
ICM\_APATHY\_TASKS global score. \[The ICM\_APATHY\_TASKS test three main presumed mechanisms of apathy: lack of motivation, cognitive inertia, and the decoupling between motivation and action. These tasks integrate two orthogonal dimensions: 1/ The cognitive dimension: modulation of the level of cognitive strategy (to study cognitive inertia); 2/ The motivational dimension: modulation of the reward at stake (to study lack of motivation)\].
Time frame: 60 minutes
MMSE
\[Part of the neuropsychological assessment\] - Mini Mental State Exam - MMSE global score
Time frame: 5 minutes
MADRS
\[Part of the neuropsychological assessment\] - Montgomery-Åsberg Depression Rating Scale - MADRS global score
Time frame: 10 minutes
EBI
\[Part of the neuropsychological assessment\] - Eating Behavior Inventory - EBI scores. \[Food behavior questionnaire. This refers to an assessment tool designed to evaluate a person's eating behaviors and identify potential risks, such as choking or aspiration, during eating\].
Time frame: 15 minutes
MATTIS
\[Part of the neuropsychological assessment\] - Mattis Dementia Rating Scale - MATTIS global score
Time frame: 20 minutes
FAB
\[Part of the neuropsychological assessment\] - Frontal Assessment Battery - FAB global score \[French version: BREF\].
Time frame: 10 minutes
HAYLING
\[Part of the neuropsychological assessment\] - Hayling Sentence Completion test - HAYLING B-A score
Time frame: 15 minutes
HAD
\[Part of the neuropsychological assessment\] Hospital Anxiety and Depression Scale - HAD global score
Time frame: 10 minutes
STROOP
\[Part of the neuropsychological assessment\] - STROOP - STROOP global score
Time frame: 3 minutes
Mini-SEA
\[Part of the neuropsychological assessment\] - Mini Social cognition and Emotional Assesment - Mini-SEA global score
Time frame: 20 minutes
Verbal Span / Lexical verbal fluency
\[Part of the neuropsychological assessment\] - Verbal Span / Lexical verbal fluency - Verbal scores
Time frame: 7 minutes
CDRS
\[Part of the neuropsychological assessment\] - Clinical Dementia Rating (CDR) Scale - CDRS global score
Time frame: 5 minutes
Gray matter volume
\[MRI analysis- Brain segmentation\] mm3
Time frame: MRI exam: 48 minutes
White matter volume
\[MRI analysis- Brain segmentation\] mm3
Time frame: MRI exam: 48 minutes
Cortical Thickness
\[MRI analysis- Brain segmentation\] mm
Time frame: MRI exam: 48 minutes
Resting-State Connectivity
\[fMRI analysis\] - strength and significance of the connection between different regions.
Time frame: MRI exam: 48 minutes
IL-6
Hormonal result \[Interleukin-6\] pg/mL
Time frame: Blood sample collection - 30 minutes
Leptin
Hormonal result \[Leptin\] ng/mL
Time frame: Blood sample collection - 30 minutes
Adiponectin
Hormonal result \[Blood adiponectin level)\] mg/L
Time frame: Blood sample collection - 30 minutes
Insulin
Hormonal result \[Fasting Insulin\] mUI/L
Time frame: Blood sample collection - 30 minutes
C-Peptide
Diabetic result \[Fasting C-Peptide level\] µg/L
Time frame: Blood sample collection - 30 minutes
FPG
Diabetic result \[Fasting Plasma Glucose\] mmol/L
Time frame: Blood sample collection - 30 minutes
HbA1C
Diabetic result \[Glycated Hemoglobin\] %
Time frame: Blood sample collection - 30 minutes
Sodium
Ionogram result \[Sodium\] mmol/L
Time frame: Blood sample collection - 30 minutes
K+
Ionogram result \[Potassium\] mmol/L
Time frame: Blood sample collection - 30 minutes
Uric acid
Ionogram result \[Uric acid\] µmol/L
Time frame: Blood sample collection - 30 minutes
Creatinine
Ionogram result \[Creatinine\] µmol/L
Time frame: Blood sample collection - 30 minutes
Total Protein
Ionogram result \[Total protein\] g/L
Time frame: Blood sample collection - 30 minutes
CRP
Inflammatory result \[C-reactive protein\] mG/L
Time frame: Blood sample collection - 30 minutes
AST
Hepatic result \[Aspartate aminotransferase\] U/L
Time frame: Blood sample collection - 30 minutes
ALT
Hepatic result \[Alanine aminotransferase\] U/L
Time frame: Blood sample collection - 30 minutes
GGT
Hepatic result \[Gamma-glutamyltransferase\] U/L
Time frame: Blood sample collection - 30 minutes
Cholesterol
Lipidic result \[Total cholesterol\] mmol/L
Time frame: Blood sample collection - 30 minutes
Triglycerides
Lipidic result \[Triglycerides\] mmol/L
Time frame: Blood sample collection - 30 minutes
HDL cholesterol
Lipidic result \[High-density lipoprotein cholesterol\] mmol/L
Time frame: Blood sample collection - 30 minutes
LDL cholesterol
Lipidic result \[Low-density lipoprotein cholesterol\] mmol/L
Time frame: Blood sample collection - 30 minutes
Glycerol
Lipidic result \[Plasma glycerol concentration\] mmol/L
Time frame: Blood sample collection - 30 minutes
FFAs
Lipidic result \[Plasma free fatty acids\] mmol/L
Time frame: Blood sample collection - 30 minutes
TSH
Thyroid result \[Thyroid-stimulating hormone blood test\] mmol/L
Time frame: Blood sample collection - 30 minutes
Plan to share: Yes — 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.
Supporting information: Study protocol
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Institut National de la Santé Et de la Recherche Médicale, France