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NCT Number: NCT03272230

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECOCAPTURE

Behavioral

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

Behavioral

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

Neuropsychological assessment

Diagnostic Test

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

Behavioral

Apathy experimental task

MRI

Other

T1 / T2 / rs-fMRI / MS-DWI

Neurohormonal mechanisms

Biological

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

Primary outcomes

  1. Frequency of each behavior in the ECOCAPTURE ethogram

    Time frame: 45 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.

    .

  2. Occurrence of each behavior in the ECOCAPTURE ethogram

    Time frame: 45 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.

    .

  3. Duration of each behavior in the ECOCAPTURE ethogram

    Time frame: 45 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.

    .

  4. Activity classes

    Time frame: 45 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)

  5. Body positions

    Time frame: 45 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).

  6. Steps

    Time frame: 45 minutes

    [Provided by the accelerometer sensor] Counting steps.

  7. Energy expenditure

    Time frame: 45 minutes

    [Provided by the accelerometer sensor] Energy expenditure during activity phases. kcal.

  8. MET

    Time frame: 45 minutes

    [Provided by the accelerometer sensor] The Metabolic Equivalent of Task: MET level.

  9. Acceleration intensity

    Time frame: 45 minutes

    [Provided by the accelerometer sensor] g.

  10. Pupil Diameter x,y

    Time frame: 7 minutes

    [Provided by the eye-tracking glasses] mm, mm.

  11. Ocular events

    Time frame: 7 minutes

    [Provided by the eye-tracking glasses] Saccades, Fixations and Blink frequency.

  12. Gaze points

    Time frame: 7 minutes

    [Provided by the eye-tracking glasses] Individual records of the participant's gaze at any given moment

Secondary outcomes

  1. STARKSTEIN (SAS)

    Time frame: 10 minutes

    [Part of the neuropsychological assessment - Starkstein Apathy Scale] SAS global score

  2. DAS

    Time frame: 10 minutes

    [Part of the neuropsychological assessment] - Dimensional Apathy Scale - DAS global score - DAS initiation score - DAS executive score - DAS emotional score.

  3. ICM_APATHY_TASKS

    Time frame: 60 minutes

    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)].

  4. MMSE

    Time frame: 5 minutes

    [Part of the neuropsychological assessment] - Mini Mental State Exam - MMSE global score

  5. MADRS

    Time frame: 10 minutes

    [Part of the neuropsychological assessment] - Montgomery-Åsberg Depression Rating Scale - MADRS global score

  6. EBI

    Time frame: 15 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].

  7. MATTIS

    Time frame: 20 minutes

    [Part of the neuropsychological assessment] - Mattis Dementia Rating Scale - MATTIS global score

  8. FAB

    Time frame: 10 minutes

    [Part of the neuropsychological assessment] - Frontal Assessment Battery - FAB global score [French version: BREF].

  9. HAYLING

    Time frame: 15 minutes

    [Part of the neuropsychological assessment] - Hayling Sentence Completion test - HAYLING B-A score

  10. HAD

    Time frame: 10 minutes

    [Part of the neuropsychological assessment] Hospital Anxiety and Depression Scale - HAD global score

  11. STROOP

    Time frame: 3 minutes

    [Part of the neuropsychological assessment] - STROOP - STROOP global score

  12. Mini-SEA

    Time frame: 20 minutes

    [Part of the neuropsychological assessment] - Mini Social cognition and Emotional Assesment - Mini-SEA global score

  13. Verbal Span / Lexical verbal fluency

    Time frame: 7 minutes

    [Part of the neuropsychological assessment] - Verbal Span / Lexical verbal fluency - Verbal scores

  14. CDRS

    Time frame: 5 minutes

    [Part of the neuropsychological assessment] - Clinical Dementia Rating (CDR) Scale - CDRS global score

  15. Gray matter volume

    Time frame: MRI exam: 48 minutes

    [MRI analysis- Brain segmentation] mm3

  16. White matter volume

    Time frame: MRI exam: 48 minutes

    [MRI analysis- Brain segmentation] mm3

  17. Cortical Thickness

    Time frame: MRI exam: 48 minutes

    [MRI analysis- Brain segmentation] mm

  18. Resting-State Connectivity

    Time frame: MRI exam: 48 minutes

    [fMRI analysis] - strength and significance of the connection between different regions.

  19. IL-6

    Time frame: Blood sample collection - 30 minutes

    Hormonal result [Interleukin-6] pg/mL

  20. Leptin

    Time frame: Blood sample collection - 30 minutes

    Hormonal result [Leptin] ng/mL

  21. Adiponectin

    Time frame: Blood sample collection - 30 minutes

    Hormonal result [Blood adiponectin level)] mg/L

  22. Insulin

    Time frame: Blood sample collection - 30 minutes

    Hormonal result [Fasting Insulin] mUI/L

  23. C-Peptide

    Time frame: Blood sample collection - 30 minutes

    Diabetic result [Fasting C-Peptide level] µg/L

  24. FPG

    Time frame: Blood sample collection - 30 minutes

    Diabetic result [Fasting Plasma Glucose] mmol/L

  25. HbA1C

    Time frame: Blood sample collection - 30 minutes

    Diabetic result [Glycated Hemoglobin] %

  26. Sodium

    Time frame: Blood sample collection - 30 minutes

    Ionogram result [Sodium] mmol/L

  27. K+

    Time frame: Blood sample collection - 30 minutes

    Ionogram result [Potassium] mmol/L

  28. Uric acid

    Time frame: Blood sample collection - 30 minutes

    Ionogram result [Uric acid] µmol/L

  29. Creatinine

    Time frame: Blood sample collection - 30 minutes

    Ionogram result [Creatinine] µmol/L

  30. Total Protein

    Time frame: Blood sample collection - 30 minutes

    Ionogram result [Total protein] g/L

  31. CRP

    Time frame: Blood sample collection - 30 minutes

    Inflammatory result [C-reactive protein] mG/L

  32. AST

    Time frame: Blood sample collection - 30 minutes

    Hepatic result [Aspartate aminotransferase] U/L

  33. ALT

    Time frame: Blood sample collection - 30 minutes

    Hepatic result [Alanine aminotransferase] U/L

  34. GGT

    Time frame: Blood sample collection - 30 minutes

    Hepatic result [Gamma-glutamyltransferase] U/L

  35. Cholesterol

    Time frame: Blood sample collection - 30 minutes

    Lipidic result [Total cholesterol] mmol/L

  36. Triglycerides

    Time frame: Blood sample collection - 30 minutes

    Lipidic result [Triglycerides] mmol/L

  37. HDL cholesterol

    Time frame: Blood sample collection - 30 minutes

    Lipidic result [High-density lipoprotein cholesterol] mmol/L

  38. LDL cholesterol

    Time frame: Blood sample collection - 30 minutes

    Lipidic result [Low-density lipoprotein cholesterol] mmol/L

  39. Glycerol

    Time frame: Blood sample collection - 30 minutes

    Lipidic result [Plasma glycerol concentration] mmol/L

  40. FFAs

    Time frame: Blood sample collection - 30 minutes

    Lipidic result [Plasma free fatty acids] mmol/L

  41. TSH

    Time frame: Blood sample collection - 30 minutes

    Thyroid result [Thyroid-stimulating hormone blood test] mmol/L

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Groupe Hospitalier Pitie-Salpetriere
  • Paris Brain Institute (ICM)

Registry information

Official study title

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

Acronym: ECOCAPTURE

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Sep 5, 2017
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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