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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT03272230

Collaborator

(none)

135

Enrollment

Location

Arms

53.7

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Apathy can be defined as a quantitative reduction of voluntary or goal-directed behavior.

So, the investigators propose a behavioral approach for assessing apathy, to obtain a quantifiable and objective signature of reduced goal-directed behavior by directly observing a patient in a real-life situation.

ECOCAPTURE consists of a multi-step scenario in a functional exploration platform equipped with data acquisition system based on video and sensors that track a participant's behavior.

The primary objective of this trial is to create a diagnostic tool for apathy, based on the video and sensors metrics.

A secondary objective of this trial is to validate a new experimental task (ICM_APATHY_TASKS) to test independently three main presumed mechanisms of apathy (motivation, cognitive inertia and coupling between motivation and action).

Another secondary objective aims to specify the pathophysiological mechanisms of apathy, corresponding to cognitive and behavioral processes, neural bases and neurohormonal mechanisms. The definition of pathophysiological mechanisms will allow the classification of apathetic patients (or several forms of apathy) and indicate which mechanism (s) best explains the apathy in a given patient.

Condition or Disease	Intervention/Treatment	Phase
Apathy Frontotemporal Dementia Parkinson Disease Depressive Symptoms	Behavioral: ECOCAPTURE Behavioral: Cognitive and Behavioral experimental tasks Diagnostic Test: Neuropsychological assessment Behavioral: ICM_APATHY_TASKS Other: MRI Biological: Neurohormonal mechanisms Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's Disease	N/A

Detailed Description

A pilot study ECOCAPTURE (ClinicalTrials.gov/NCT02496312, 2015) applied to a group of participants with the behavioural variant of frontotemporal lobar degeneration (bvFTLD) matched for age, gender and level of education to healthy participants (n=7 per group). This pilot validated the concept of ECOCAPTURE.

The purpose of this trial is to continue the implementation of the ECOCAPTURE tool, extending it to three pathological models: bvFTLD, Parkinson's disease and depression.

The objectives aim to assess behavior directed towards a goal and identify apathy, analyze data to obtain a behavioral signature of apathy and to produce more finely differentiated apathetic patients profiles by specifying the pathophysiological mechanisms (cognitive mechanisms, as well as the neural bases and the neuro-hormonal mechanisms) underlying apathy.

The investigators use multimodal recording tools to track behavior. A multiple-camera system is set up with video coverage of the whole room. A sensor (Move II, Movisens, Karlsruhe, Germany) fixed to the subject's hip, records data such as 3D acceleration, barometric pressure and temperature. From these data, secondary parameters like activity class, body position, steps, energy expenditure and metabolic equivalents are calculated. Video data analysis is performed with The Observer XT software (Noldus, Wageningen, The Netherlands) using an ethogram to identify the frequency and duration of behaviors. For 10 min, during the experimental session, participants ware eye-tracking glasses (ETG 2w, SMI, Teltow, Germany) that record natural gaze behavior.

Metrics built from raw data (video, sensors) are analyzed to reveal a behavioral signature of apathy, highlighting a quantitative reduction in goal-directed behavior.

The study takes place on two visits (one per day). It consists of the observation phase, a neuropsychological assessment, experimental tasks, some of which are computerized, an MRI examination and finally a blood test.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

135 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 6, 2017

Anticipated Primary Completion Date :

Jul 31, 2019

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bvFTD Initially especially patients diagnosed with behavioral variant frontotemporal dementia (bvFTD) according to the Rascovsky criteria (Rascovsky et al. 2011). ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms	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 Diagnostic Test: Neuropsychological assessment MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS Behavioral: ICM_APATHY_TASKS Apathy experimental task Other: MRI T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI Biological: Neurohormonal mechanisms Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
Experimental: Healthy control Healthy age, sex and education matched controls ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms	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 Diagnostic Test: Neuropsychological assessment MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS Behavioral: ICM_APATHY_TASKS Apathy experimental task Other: MRI T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI Biological: Neurohormonal mechanisms Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
Experimental: Parkinson's disease without Impulse Control Disorders (ICDs) Initially especially patients diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992). ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / Supplementary Neuropsychological assessment - Parkinson's disease / MRI / Neurohormonal mechanisms	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 Diagnostic Test: Neuropsychological assessment MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS Behavioral: ICM_APATHY_TASKS Apathy experimental task Other: MRI T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI Biological: Neurohormonal mechanisms Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's Disease ACDD / QUIP / BIS-11 / ECMP / QUIP-RS
Experimental: Depression Initially especially patients diagnosed with depression (Major Depressive Disorder, DSM-IV). ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms	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 Diagnostic Test: Neuropsychological assessment MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS Behavioral: ICM_APATHY_TASKS Apathy experimental task Other: MRI T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI Biological: Neurohormonal mechanisms Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
Experimental: Parkinson's disease with Impulse Control Disorders (ICDs) Initially especially patients diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992). ICDs are closely related to use of dopaminergic medications. ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / Supplementary Neuropsychological assessment - Parkinson's disease / MRI / Neurohormonal mechanisms	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 Diagnostic Test: Neuropsychological assessment MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS Behavioral: ICM_APATHY_TASKS Apathy experimental task Other: MRI T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI Biological: Neurohormonal mechanisms Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's Disease ACDD / QUIP / BIS-11 / ECMP / QUIP-RS

Outcome Measures

Primary Outcome Measures

Occurrence of each behavior from the ethogram [45 min]
[Provided by the video recording and The Observer NOLDUS software] integer.
Frequency of each behavior from the ethogram [45 min]
[Provided by the video recording and The Observer NOLDUS software] integer.
Duration of each behavior from the ethogram [45 min]
[Provided by the video recording and The Observer NOLDUS software] integer.
Number of different behaviors [45 min]
[Provided by the video recording and The Observer NOLDUS software] integer.
Activity classes [45 min]
[Provided by the MOVE MOVISENS sensor] lying, sitting, ...
Body positions [45 min]
[Provided by the MOVE MOVISENS sensor] lying left, ...
Energy expenditure [45 min]
[Provided by the MOVE MOVISENS sensor] kcal.
MET [45 min]
[Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task: MET level.
Steps [45 min]
[Provided by the MOVE MOVISENS sensor] Counting steps.
Acceleration intensity [45 min]
[Provided by the MOVE MOVISENS sensor] g.
Pupil Diameter x [10 min]
[Provided by the eye-tracking glasses SMI ETG 2w] mm.
Pupil Diameter y [10 min]
[Provided by the eye-tracking glasses SMI ETG 2w] mm.

Secondary Outcome Measures

ICM_APATHY_TASKS [At day 1]
ICM_APATHY_TASKS global score
MMSE [At day 1]
[Mini Mental State Exam] MMSE global score
MATTIS [At day 1]
[Mattis Dementia Rating Scale ] MATTIS global score
NART [At day 1]
[National Adult Reading Test] NART IQ (global score)
BREF (FAB english) [At day 1]
[Frontal Assessment Battery] BREF global score
HAYLING [At day 1]
[Hayling Sentence Completion test] ] HAYLING global score
HAD [At day 1]
[Hospital Anxiety and Depression Scale] ]HAD global score
Gray matter volume [At day 2]
[MRI analysis- Brain segmentation] mm3
White matter volume [At day 2]
[MRI analysis- Brain segmentation] mm3
Cerebral Spinal Fluid volume [At day 2]
[MRI analysis- Brain segmentation] mm3
Brain lesion localization [At day 2]
[MRI analysis- Brain segmentation] Talairach x,y,z coordinates
IL-6 [At day 1]
Hormonal result [Interleukin-6] pg/mL
Leptin [At day 1]
Hormonal result [Leptin] ng/mL
Adiponectin [At day 1]
Hormonal result [Blood adiponectin level)] mg/L
Insulin [At day 1]
Hormonal result [Fasting Insulin] mUI/L
C-Peptide [At day 1]
Diabetic result [Fasting C-Peptide level] µg/L
FPG [At day 1]
Diabetic result [Fasting Plasma Glucose] mmol/L
HbA1C [At day 1]
Diabetic result [Glycated Hemoglobin] %
K+ [At day 1]
Ionogram result [Potassium] mmol/L
Uric acid [At day 1]
Ionogram result [Uric acid] µmol/L
Creatinine [At day 1]
Ionogram result [Creatinine] µmol/L
Total Protein [At day 1]
Ionogram result [Total protein] g/L
CRP [At day 1]
Inflammatory result [C-reactive protein] mG/L
AST [At day 1]
Hepatic result [Aspartate aminotransferase] U/L
ALT [At day 1]
Hepatic result [Alanine aminotransferase] U/L
GGT [At day 1]
Hepatic result [Gamma-glutamyltransferase] U/L
Cholesterol [At day 1]
Lipidic result [Total cholesterol] mmol/L
Triglycerides [At day 1]
Lipidic result [Triglycerides] mmol/L
HDL cholesterol [At day 1]
Lipidic result [High-density lipoprotein cholesterol] mmol/L
LDL cholesterol [At day 1]
Lipidic result [Low-density lipoprotein cholesterol] mmol/L
Glycerol [At day 1]
Lipidic result [Plasma glycerol concentration] mmol/L
FFAs [At day 1]
Lipidic result [Plasma free fatty acids] mmol/L
TSH [At day 1]
Thyroid result [Thyroid-stimulating hormone blood test] mmol/L
DAS [At day 1]
[Dimensional Apathy Scale] DAS global score
STARKSTEIN (SAS) [At day 1]
[Starkstein Apathy Scale (SAS)] SAS global score
MADRS [At day 1]
[Montgomery-Åsberg Depression Rating Scale] MADRS global score
EBI [At day 1]
[Eating Behavior Inventory] EBI global score
ACDD [At day 1]
[Autoévaluation des Comportements Dopamine Dépendants] ACDD answers
QUIP [At day 1]
[Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease] QUIP answers
BIS-11 [At day 1]
[Barratt Impulsiveness Scale] BIS-11 global score
Mini-SEA [At day 1]
[Mini Social cognition and Emotional Assesment] Mini-SEA global score
STROOP [At day 1]
[STROOP Test] STROOP global score
ECMP [At day 1]
[Evaluation Comportementale dans la Maladie de Parkinson] ECMP answers
QUIP-RS [At day 1]
[Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale] QUIP-RS global score

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All groups:

Ability to give informed consent for study procedures
Ability to understand study instructions and to realize the cognitive tasks
Person with health insurance

Patients:

MMS>20
Absence of another neurological or psychiatric disease
Presence of a caregiver
We will recruit three groups of patients:
diagnosed with behavioral variant frontotemporal dementia (bvFTD) according to the Rascovsky criteria (Rascovsky et al. 2011)
diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992)
Sub-group 1: Parkinson's disease with Impulse Control Disorders (ICDs)
Sub-group 2: Parkinson's disease without Impulse Control Disorders (ICDs)
diagnosed with depression (Major Depressive Disorder, DSM-IV)

Healthy age,sex, education-matched controls:

MMS>27
Absence of neurological or psychiatric disease

Exclusion Criteria:

Standard contraindications to MRI
Inability to understand study instructions
Person mentioned in the article L.1121-5 to L. 1121-8 and L. 1122-12 of the French Public Health Code