Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Frequency of each behavior in the ECOCAPTURE ethogram
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 ≥
- •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 >
- •Medical History: No history of neurological or psychiatric disorders.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: ICM_APATHY_TASKS (Behavioral)
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.
干预措施: MRI (Other)
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.
干预措施: ECOCAPTURE (Behavioral)
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.
干预措施: Cognitive and Behavioral experimental tasks (Behavioral)
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.
干预措施: Neuropsychological assessment (Diagnostic Test)
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.
干预措施: Neurohormonal mechanisms (Biological)
结局指标
主要结局
Frequency of each behavior in the ECOCAPTURE ethogram
时间窗: 45 min
\[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer. .
Occurrence of each behavior in the ECOCAPTURE ethogram
时间窗: 45 min
\[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer. .
Duration of each behavior in the ECOCAPTURE ethogram
时间窗: 45 min
\[Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram\] integer. .
Activity classes
时间窗: 45 min
\[Provided by the accelerometer sensor\] 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)
Body positions
时间窗: 45 min
\[Provided by the accelerometer sensor\] 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).
Steps
时间窗: 45 min
\[Provided by the accelerometer sensor\] Counting steps.
Energy expenditure
时间窗: 45 min
\[Provided by the accelerometer sensor\] Energy expenditure during activity phases. kcal.
MET
时间窗: 45 min
\[Provided by the accelerometer sensor\] The Metabolic Equivalent of Task: MET level.
Acceleration intensity
时间窗: 45 min
\[Provided by the accelerometer sensor\] g.
Pupil Diameter x,y
时间窗: 7 min
\[Provided by the eye-tracking glasses\] mm, mm.
Ocular events
时间窗: 7 mn
\[Provided by the eye-tracking glasses\] Saccades, Fixations and Blink frequency.
Gaze points
时间窗: 7 mn
\[Provided by the eye-tracking glasses\] Individual records of the participant's gaze at any given moment
次要结局
- STARKSTEIN (SAS)(10 mn)
- DAS(10 mn)
- ICM_APATHY_TASKS(1 hour)
- MMSE(5 mn)
- MADRS(10 mn)
- EBI(15 mn)
- MATTIS(20 mn)
- FAB(10 mn)
- HAYLING(15 mn)
- HAD(10 mn)
- STROOP(3 mn)
- Mini-SEA(20 mn)
- Verbal Span / Lexical verbal fluency(7 mn)
- CDRS(5 mn)
- Gray matter volume(MRI exam: 48 mn)
- White matter volume(MRI exam: 48 mn)
- Cortical Thickness(MRI exam: 48 mn)
- Resting-State Connectivity(MRI exam: 48 mn)
- IL-6(Blood sample collection - 30 mn)
- Leptin(Blood sample collection - 30 mn)
- Adiponectin(Blood sample collection - 30 mn)
- Insulin(Blood sample collection - 30 mn)
- C-Peptide(Blood sample collection - 30 mn)
- FPG(Blood sample collection - 30 mn)
- HbA1C(Blood sample collection - 30 mn)
- Sodium(Blood sample collection - 30 mn)
- K+(Blood sample collection - 30 mn)
- Uric acid(Blood sample collection - 30 mn)
- Creatinine(Blood sample collection - 30 mn)
- Total Protein(Blood sample collection - 30 mn)
- CRP(Blood sample collection - 30 mn)
- AST(Blood sample collection - 30 mn)
- ALT(Blood sample collection - 30 mn)
- GGT(Blood sample collection - 30 mn)
- Cholesterol(Blood sample collection - 30 mn)
- Triglycerides(Blood sample collection - 30 mn)
- HDL cholesterol(Blood sample collection - 30 mn)
- LDL cholesterol(Blood sample collection - 30 mn)
- Glycerol(Blood sample collection - 30 mn)
- FFAs(Blood sample collection - 30 mn)
- TSH(Blood sample collection - 30 mn)