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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03272230
Acronym
ECOCAPTURE
Enrollment
66
Registered
2017-09-05
Start date
2017-09-06
Completion date
2024-05-08
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apathy, Behavioral Variant Frontotemporal Dementia (bvFTD), Depression - Major Depressive Disorder, Disinhibition

Keywords

Apathy, Goal-directed behavior, Assessment, Diagnosis, Sensor, Ecological condition, Neurological disease, Dementia, Human ethology, Behavioral sensing, Accelerometer, Disinhibition, ECOCAPTURE

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.

Interventions

BEHAVIORALECOCAPTURE

45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system

BEHAVIORALCognitive and Behavioral experimental tasks

Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions

DIAGNOSTIC_TESTNeuropsychological assessment

STARKSTEIN APATHY SCALE (SAS) / DAS / MMSE / MADRS / EBI / MINI-SEA / FAB / HAD / MATTIS / HAYLING / STROOP / Verbal Span / Lexical verbal fluency / TMT / CDRS

BEHAVIORALICM_APATHY_TASKS

Apathy experimental task

OTHERMRI

T1 / T2 / rs-fMRI / MS-DWI

BIOLOGICALNeurohormonal mechanisms

Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV
Institut du Cerveau et de la Moelle (ICM Institute)
CollaboratorUNKNOWN
Groupe Hospitalier Pitie-Salpetriere
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of each behavior in the ECOCAPTURE ethogram45 minutes\[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer. .
Occurrence of each behavior in the ECOCAPTURE ethogram45 minutes\[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer. .
Duration of each behavior in the ECOCAPTURE ethogram45 minutes\[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer. .
Activity classes45 minutes\[Provided by the accelerometer sensor\] 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 positions45 minutes\[Provided by the accelerometer sensor\] 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).
Steps45 minutes\[Provided by the accelerometer sensor\] Counting steps.
Energy expenditure45 minutes\[Provided by the accelerometer sensor\] Energy expenditure during activity phases. kcal.
MET45 minutes\[Provided by the accelerometer sensor\] The Metabolic Equivalent of Task: MET level.
Acceleration intensity45 minutes\[Provided by the accelerometer sensor\] g.
Pupil Diameter x,y7 minutes\[Provided by the eye-tracking glasses\] mm, mm.
Ocular events7 minutes\[Provided by the eye-tracking glasses\] Saccades, Fixations and Blink frequency.
Gaze points7 minutes\[Provided by the eye-tracking glasses\] Individual records of the participant's gaze at any given moment

Secondary

MeasureTime frameDescription
STARKSTEIN (SAS)10 minutes\[Part of the neuropsychological assessment - Starkstein Apathy Scale\] SAS global score
DAS10 minutes\[Part of the neuropsychological assessment\] - Dimensional Apathy Scale - DAS global score - DAS initiation score - DAS executive score - DAS emotional score.
ICM_APATHY_TASKS60 minutesICM\_APATHY\_TASKS global score. \[The ICM\_APATHY\_TASKS test three main presumed mechanisms of apathy: lack of motivation, cognitive inertia, and the decoupling between motivation and action. These tasks integrate two orthogonal dimensions: 1/ The cognitive dimension: modulation of the level of cognitive strategy (to study cognitive inertia); 2/ The motivational dimension: modulation of the reward at stake (to study lack of motivation)\].
MMSE5 minutes\[Part of the neuropsychological assessment\] - Mini Mental State Exam - MMSE global score
MADRS10 minutes\[Part of the neuropsychological assessment\] - Montgomery-Åsberg Depression Rating Scale - MADRS global score
EBI15 minutes\[Part of the neuropsychological assessment\] - Eating Behavior Inventory - EBI scores. \[Food behavior questionnaire. This refers to an assessment tool designed to evaluate a person's eating behaviors and identify potential risks, such as choking or aspiration, during eating\].
MATTIS20 minutes\[Part of the neuropsychological assessment\] - Mattis Dementia Rating Scale - MATTIS global score
FAB10 minutes\[Part of the neuropsychological assessment\] - Frontal Assessment Battery - FAB global score \[French version: BREF\].
HAYLING15 minutes\[Part of the neuropsychological assessment\] - Hayling Sentence Completion test - HAYLING B-A score
HAD10 minutes\[Part of the neuropsychological assessment\] Hospital Anxiety and Depression Scale - HAD global score
STROOP3 minutes\[Part of the neuropsychological assessment\] - STROOP - STROOP global score
Mini-SEA20 minutes\[Part of the neuropsychological assessment\] - Mini Social cognition and Emotional Assesment - Mini-SEA global score
Verbal Span / Lexical verbal fluency7 minutes\[Part of the neuropsychological assessment\] - Verbal Span / Lexical verbal fluency - Verbal scores
CDRS5 minutes\[Part of the neuropsychological assessment\] - Clinical Dementia Rating (CDR) Scale - CDRS global score
Gray matter volumeMRI exam: 48 minutes\[MRI analysis- Brain segmentation\] mm3
White matter volumeMRI exam: 48 minutes\[MRI analysis- Brain segmentation\] mm3
Cortical ThicknessMRI exam: 48 minutes\[MRI analysis- Brain segmentation\] mm
Resting-State ConnectivityMRI exam: 48 minutes\[fMRI analysis\] - strength and significance of the connection between different regions.
IL-6Blood sample collection - 30 minutesHormonal result \[Interleukin-6\] pg/mL
LeptinBlood sample collection - 30 minutesHormonal result \[Leptin\] ng/mL
AdiponectinBlood sample collection - 30 minutesHormonal result \[Blood adiponectin level)\] mg/L
InsulinBlood sample collection - 30 minutesHormonal result \[Fasting Insulin\] mUI/L
C-PeptideBlood sample collection - 30 minutesDiabetic result \[Fasting C-Peptide level\] µg/L
FPGBlood sample collection - 30 minutesDiabetic result \[Fasting Plasma Glucose\] mmol/L
HbA1CBlood sample collection - 30 minutesDiabetic result \[Glycated Hemoglobin\] %
SodiumBlood sample collection - 30 minutesIonogram result \[Sodium\] mmol/L
K+Blood sample collection - 30 minutesIonogram result \[Potassium\] mmol/L
Uric acidBlood sample collection - 30 minutesIonogram result \[Uric acid\] µmol/L
CreatinineBlood sample collection - 30 minutesIonogram result \[Creatinine\] µmol/L
Total ProteinBlood sample collection - 30 minutesIonogram result \[Total protein\] g/L
CRPBlood sample collection - 30 minutesInflammatory result \[C-reactive protein\] mG/L
ASTBlood sample collection - 30 minutesHepatic result \[Aspartate aminotransferase\] U/L
ALTBlood sample collection - 30 minutesHepatic result \[Alanine aminotransferase\] U/L
GGTBlood sample collection - 30 minutesHepatic result \[Gamma-glutamyltransferase\] U/L
CholesterolBlood sample collection - 30 minutesLipidic result \[Total cholesterol\] mmol/L
TriglyceridesBlood sample collection - 30 minutesLipidic result \[Triglycerides\] mmol/L
HDL cholesterolBlood sample collection - 30 minutesLipidic result \[High-density lipoprotein cholesterol\] mmol/L
LDL cholesterolBlood sample collection - 30 minutesLipidic result \[Low-density lipoprotein cholesterol\] mmol/L
GlycerolBlood sample collection - 30 minutesLipidic result \[Plasma glycerol concentration\] mmol/L
FFAsBlood sample collection - 30 minutesLipidic result \[Plasma free fatty acids\] mmol/L
TSHBlood sample collection - 30 minutesThyroid result \[Thyroid-stimulating hormone blood test\] mmol/L

Countries

France

Contacts

PRINCIPAL_INVESTIGATORRichard LEVY, MD, PhD

Assistance Publique - Hôpitaux de Paris

STUDY_CHAIRBénédicte BATRANCOURT, PhD

Institut National de la Santé Et de la Recherche Médicale, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026