Trials / Completed

CompletedNCT03272230

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
Phase: N/A
Study type: Interventional
Enrollment: 66 (actual)

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
Sex: All
Age: 40 Years – 85 Years
Healthy volunteers: Accepted

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.

Conditions

Interventions

Type	Name	Description
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
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
BEHAVIORAL	ICM_APATHY_TASKS	Apathy experimental task
OTHER	MRI	T1 / T2 / rs-fMRI / MS-DWI
BIOLOGICAL	Neurohormonal mechanisms	Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage

Timeline

Start date: 2017-09-06
Primary completion: 2023-12-08
Completion: 2024-05-08
First posted: 2017-09-05
Last updated: 2024-11-29

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03272230. Inclusion in this directory is not an endorsement.