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

May 18, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75013
        • Paris Brain Institute / ICM / Pitié-Salpêtrière Hospital AP-HP / CIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Healthy volunteers
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
Behavioral: ICM_APATHY_TASKS
Apathy experimental task
Biological: Neurohormonal mechanisms
Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
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
Other: MRI
T1 / T2 / rs-fMRI / MS-DWI
Experimental: 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.
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
Behavioral: ICM_APATHY_TASKS
Apathy experimental task
Biological: Neurohormonal mechanisms
Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
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
Other: MRI
T1 / T2 / rs-fMRI / MS-DWI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.

.
45 minutes
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.

.
45 minutes
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.

.
45 minutes
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)
45 minutes
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).
45 minutes
Steps
Time Frame: 45 minutes
[Provided by the accelerometer sensor] Counting steps.
45 minutes
Energy expenditure
Time Frame: 45 minutes
[Provided by the accelerometer sensor] Energy expenditure during activity phases. kcal.
45 minutes
MET
Time Frame: 45 minutes
[Provided by the accelerometer sensor] The Metabolic Equivalent of Task: MET level.
45 minutes
Acceleration intensity
Time Frame: 45 minutes
[Provided by the accelerometer sensor] g.
45 minutes
Pupil Diameter x,y
Time Frame: 7 minutes
[Provided by the eye-tracking glasses] mm, mm.
7 minutes
Ocular events
Time Frame: 7 minutes
[Provided by the eye-tracking glasses] Saccades, Fixations and Blink frequency.
7 minutes
Gaze points
Time Frame: 7 minutes
[Provided by the eye-tracking glasses] Individual records of the participant's gaze at any given moment
7 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
STARKSTEIN (SAS)
Time Frame: 10 minutes
[Part of the neuropsychological assessment - Starkstein Apathy Scale] SAS global score
10 minutes
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.
10 minutes
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)].
60 minutes
MMSE
Time Frame: 5 minutes
[Part of the neuropsychological assessment] - Mini Mental State Exam - MMSE global score
5 minutes
MADRS
Time Frame: 10 minutes
[Part of the neuropsychological assessment] - Montgomery-Åsberg Depression Rating Scale - MADRS global score
10 minutes
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].
15 minutes
MATTIS
Time Frame: 20 minutes
[Part of the neuropsychological assessment] - Mattis Dementia Rating Scale - MATTIS global score
20 minutes
FAB
Time Frame: 10 minutes
[Part of the neuropsychological assessment] - Frontal Assessment Battery - FAB global score [French version: BREF].
10 minutes
HAYLING
Time Frame: 15 minutes
[Part of the neuropsychological assessment] - Hayling Sentence Completion test - HAYLING B-A score
15 minutes
HAD
Time Frame: 10 minutes
[Part of the neuropsychological assessment] Hospital Anxiety and Depression Scale - HAD global score
10 minutes
STROOP
Time Frame: 3 minutes
[Part of the neuropsychological assessment] - STROOP - STROOP global score
3 minutes
Mini-SEA
Time Frame: 20 minutes
[Part of the neuropsychological assessment] - Mini Social cognition and Emotional Assesment - Mini-SEA global score
20 minutes
Verbal Span / Lexical verbal fluency
Time Frame: 7 minutes
[Part of the neuropsychological assessment] - Verbal Span / Lexical verbal fluency - Verbal scores
7 minutes
CDRS
Time Frame: 5 minutes
[Part of the neuropsychological assessment] - Clinical Dementia Rating (CDR) Scale - CDRS global score
5 minutes
Gray matter volume
Time Frame: MRI exam: 48 minutes
[MRI analysis- Brain segmentation] mm3
MRI exam: 48 minutes
White matter volume
Time Frame: MRI exam: 48 minutes
[MRI analysis- Brain segmentation] mm3
MRI exam: 48 minutes
Cortical Thickness
Time Frame: MRI exam: 48 minutes
[MRI analysis- Brain segmentation] mm
MRI exam: 48 minutes
Resting-State Connectivity
Time Frame: MRI exam: 48 minutes
[fMRI analysis] - strength and significance of the connection between different regions.
MRI exam: 48 minutes
IL-6
Time Frame: Blood sample collection - 30 minutes
Hormonal result [Interleukin-6] pg/mL
Blood sample collection - 30 minutes
Leptin
Time Frame: Blood sample collection - 30 minutes
Hormonal result [Leptin] ng/mL
Blood sample collection - 30 minutes
Adiponectin
Time Frame: Blood sample collection - 30 minutes
Hormonal result [Blood adiponectin level)] mg/L
Blood sample collection - 30 minutes
Insulin
Time Frame: Blood sample collection - 30 minutes
Hormonal result [Fasting Insulin] mUI/L
Blood sample collection - 30 minutes
C-Peptide
Time Frame: Blood sample collection - 30 minutes
Diabetic result [Fasting C-Peptide level] µg/L
Blood sample collection - 30 minutes
FPG
Time Frame: Blood sample collection - 30 minutes
Diabetic result [Fasting Plasma Glucose] mmol/L
Blood sample collection - 30 minutes
HbA1C
Time Frame: Blood sample collection - 30 minutes
Diabetic result [Glycated Hemoglobin] %
Blood sample collection - 30 minutes
Sodium
Time Frame: Blood sample collection - 30 minutes
Ionogram result [Sodium] mmol/L
Blood sample collection - 30 minutes
K+
Time Frame: Blood sample collection - 30 minutes
Ionogram result [Potassium] mmol/L
Blood sample collection - 30 minutes
Uric acid
Time Frame: Blood sample collection - 30 minutes
Ionogram result [Uric acid] µmol/L
Blood sample collection - 30 minutes
Creatinine
Time Frame: Blood sample collection - 30 minutes
Ionogram result [Creatinine] µmol/L
Blood sample collection - 30 minutes
Total Protein
Time Frame: Blood sample collection - 30 minutes
Ionogram result [Total protein] g/L
Blood sample collection - 30 minutes
CRP
Time Frame: Blood sample collection - 30 minutes
Inflammatory result [C-reactive protein] mG/L
Blood sample collection - 30 minutes
AST
Time Frame: Blood sample collection - 30 minutes
Hepatic result [Aspartate aminotransferase] U/L
Blood sample collection - 30 minutes
ALT
Time Frame: Blood sample collection - 30 minutes
Hepatic result [Alanine aminotransferase] U/L
Blood sample collection - 30 minutes
GGT
Time Frame: Blood sample collection - 30 minutes
Hepatic result [Gamma-glutamyltransferase] U/L
Blood sample collection - 30 minutes
Cholesterol
Time Frame: Blood sample collection - 30 minutes
Lipidic result [Total cholesterol] mmol/L
Blood sample collection - 30 minutes
Triglycerides
Time Frame: Blood sample collection - 30 minutes
Lipidic result [Triglycerides] mmol/L
Blood sample collection - 30 minutes
HDL cholesterol
Time Frame: Blood sample collection - 30 minutes
Lipidic result [High-density lipoprotein cholesterol] mmol/L
Blood sample collection - 30 minutes
LDL cholesterol
Time Frame: Blood sample collection - 30 minutes
Lipidic result [Low-density lipoprotein cholesterol] mmol/L
Blood sample collection - 30 minutes
Glycerol
Time Frame: Blood sample collection - 30 minutes
Lipidic result [Plasma glycerol concentration] mmol/L
Blood sample collection - 30 minutes
FFAs
Time Frame: Blood sample collection - 30 minutes
Lipidic result [Plasma free fatty acids] mmol/L
Blood sample collection - 30 minutes
TSH
Time Frame: Blood sample collection - 30 minutes
Thyroid result [Thyroid-stimulating hormone blood test] mmol/L
Blood sample collection - 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Groupe Hospitalier Pitie-Salpetriere
Institut du Cerveau et de la Moelle (ICM Institute)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C16-87
  • 2017-A00416-47 (Registry Identifier: RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

2026-2030

IPD Sharing Access Criteria

Researchers must contact the scientific leaders of the study, and an agreement must be established with the sponsor (INSERM).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Study Protocol
    Information comments: The ECOCAPTURE ethograms: apathy ethogram and disinhibition ethogram
  2. Individual Participant Data Set
    Information comments: ECOCAPTURE Dataset - Behavioral coding from video - 17 bvFTD and 18 HC - 28.04.2022
  3. Individual Participant Data Set
    Information comments: ECOCAPTURE Dataset - Behavioral coding from video - 20 bvFTD and 18 HC - 21.03.2022
  4. Individual Participant Data Set
    Information comments: ECOCAPTURE Dataset - Behavioral coding from video - 23 bvFTD and 24 HC - 28.11.2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Apathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings