Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
ECOCAPTURE
2 other identifiers
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
September 5, 2017
CompletedStudy Start
First participant enrolled
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2024
CompletedNovember 29, 2024
November 1, 2024
6.3 years
August 3, 2017
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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. .
45 min
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. .
45 min
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. .
45 min
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)
45 min
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).
45 min
Steps
\[Provided by the accelerometer sensor\] Counting steps.
45 min
Energy expenditure
\[Provided by the accelerometer sensor\] Energy expenditure during activity phases. kcal.
45 min
MET
\[Provided by the accelerometer sensor\] The Metabolic Equivalent of Task: MET level.
45 min
Acceleration intensity
\[Provided by the accelerometer sensor\] g.
45 min
Pupil Diameter x,y
\[Provided by the eye-tracking glasses\] mm, mm.
7 min
Ocular events
\[Provided by the eye-tracking glasses\] Saccades, Fixations and Blink frequency.
7 mn
Gaze points
\[Provided by the eye-tracking glasses\] Individual records of the participant's gaze at any given moment
7 mn
Secondary Outcomes (41)
STARKSTEIN (SAS)
10 mn
DAS
10 mn
ICM_APATHY_TASKS
1 hour
MMSE
5 mn
MADRS
10 mn
- +36 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALThe 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.
Interventions
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
Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paris Brain Institute / ICM / Pitié-Salpêtrière Hospital AP-HP / CIC
Paris, 75013, France
Related Publications (8)
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.
PMID: 33851004RESULTGodefroy 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.
PMID: 35751676RESULTGodefroy 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.
PMID: 36155506RESULTGodefroy 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.
PMID: 39345385RESULTBatrancourt 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.
PMID: 31551908RESULTPeltier 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.
PMID: 35653896RESULTTanguy 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.
PMID: 35700600RESULTTanguy 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.
PMID: 36658040RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard LEVY, MD, PhD
Assistance Publique - Hôpitaux de Paris
- STUDY CHAIR
Bénédicte BATRANCOURT, PhD
Institut National de la Santé Et de la Recherche Médicale, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2017
First Posted
September 5, 2017
Study Start
September 6, 2017
Primary Completion
December 8, 2023
Study Completion
May 8, 2024
Last Updated
November 29, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 2026-2030
- Access Criteria
- Researchers must contact the scientific leaders of the study, and an agreement must be established with the sponsor (INSERM).
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.