Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System (NCT03272230) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
France66 participantsStarted 2017-09-06
Plain-language 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.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used video cameras, body sensors, and eye-tracking technology to observe and measure behaviors like apathy and disinhibition in real-life settings — can you explain what that kind of monitoring actually involved for participants, and whether findings from this completed study are changing how apathy in conditions like bvFTD is diagnosed or assessed?
2Since this trial focused on measuring behaviors like apathy, disinhibition, and depression rather than testing a treatment, does the ECOCAPTURE system it studied have any practical role in evaluating my own symptoms or tracking changes over time in our clinic?
3The trial included people with both behavioral variant frontotemporal dementia and major depressive disorder, which can sometimes look similar — could the kind of objective behavioral measurement this study explored help clarify which condition might be driving my symptoms?
4Because this was a measurement and observation study rather than a drug or therapy trial, are there any direct risks or burdens I should know about if a similar assessment approach were ever used in my care?
5Now that this trial is completed, are there published results I could review with you, and do those findings point toward any next steps — like follow-up treatment trials — that might be relevant to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of each behavior in the ECOCAPTURE ethogram
Timeframe: 45 minutes
2
Occurrence of each behavior in the ECOCAPTURE ethogram
Timeframe: 45 minutes
3
Duration of each behavior in the ECOCAPTURE ethogram
Timeframe: 45 minutes
4
Activity classes
Timeframe: 45 minutes
5
Body positions
Timeframe: 45 minutes
6
Steps
Timeframe: 45 minutes
7
Energy expenditure
Timeframe: 45 minutes
8
MET
Timeframe: 45 minutes
Trial details
NCT IDNCT03272230
SponsorInstitut National de la Santé Et de la Recherche Médicale, France