Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
NCT ID: NCT03272230
Last Updated: 2024-11-29
Study Results
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Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2017-09-06
2024-05-08
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
ECOCAPTURE
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
Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions
Neuropsychological assessment
STARKSTEIN APATHY SCALE (SAS) / DAS / MMSE / MADRS / EBI / MINI-SEA / FAB / HAD / MATTIS / HAYLING / STROOP / Verbal Span / Lexical verbal fluency / TMT / CDRS
ICM_APATHY_TASKS
Apathy experimental task
MRI
T1 / T2 / rs-fMRI / MS-DWI
Neurohormonal mechanisms
Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
Interventions
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ECOCAPTURE
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
Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions
Neuropsychological assessment
STARKSTEIN APATHY SCALE (SAS) / DAS / MMSE / MADRS / EBI / MINI-SEA / FAB / HAD / MATTIS / HAYLING / STROOP / Verbal Span / Lexical verbal fluency / TMT / CDRS
ICM_APATHY_TASKS
Apathy experimental task
MRI
T1 / T2 / rs-fMRI / MS-DWI
Neurohormonal mechanisms
Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
85 Years
ALL
Yes
Sponsors
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Brain Institute Paris (ICM)
UNKNOWN
Pitié-Salpêtrière Hospital (AP-HP)
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Richard LEVY, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Bénédicte BATRANCOURT, PhD
Role: STUDY_CHAIR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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Paris Brain Institute / ICM / Pitié-Salpêtrière Hospital AP-HP / CIC
Paris, , France
Countries
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References
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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 Documents
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Document Type: Study Protocol
The ECOCAPTURE ethograms: apathy ethogram and disinhibition ethogram
View DocumentDocument Type: Individual Participant Data Set
ECOCAPTURE Dataset - Behavioral coding from video - 17 bvFTD and 18 HC - 28.04.2022
View DocumentDocument Type: Individual Participant Data Set
ECOCAPTURE Dataset - Behavioral coding from video - 20 bvFTD and 18 HC - 21.03.2022
View DocumentDocument Type: Individual Participant Data Set
ECOCAPTURE Dataset - Behavioral coding from video - 23 bvFTD and 24 HC - 28.11.2022
View DocumentOther Identifiers
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2017-A00416-47
Identifier Type: REGISTRY
Identifier Source: secondary_id
C16-87
Identifier Type: -
Identifier Source: org_study_id