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

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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease; Depressive Symptoms; Frontotemporal Dementia; Apathy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bénédicte M BATRANCOURT, PhD; Phone Number: (33-6) 60 44 79 79; Email: benedicte.batrancourt@upmc.fr
• Study Contact Backup: Name: Armelle RAMETTI-LACROUX, PhD; Phone Number: (33-1) 42 16 55 20; Email: armelle.ramettilacroux@icm-institute.org

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • ICM / Pitié-Salpêtrière Hospital AP-HP / CIC
    • Contact: Armelle RAMETTI-LACROUX, PhD; Phone Number: (33-1) 42 16 55 20; Email: armelle.ramettilacroux@icm-institute.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Richard Levy, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Assessment; Diagnosis; Apathy; Sensor; Goal-directed behavior; Neurological disease; Ecological condition
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Depression; Parkinson Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: C16-87; 2017-A00416-47 (Registry Identifier: RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No