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

Parkinson Disease Clinical Trial

— ECOCAPTURE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03272230
• Other study ID #: C16-87
• Secondary ID: 2017-A00416-47
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2019
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Bénédicte M BATRANCOURT, PhD
• Phone: (33-6) 60 44 79 79
• Email: benedicte.batrancourt[@]upmc.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: February 28, 2022
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Apathy
• Aphasia, Primary Progressive
• Dementia
• Depression
• Depressive Symptoms
• Frontotemporal Dementia
• Parkinson Disease
• Pick Disease of the Brain

Intervention

Behavioral:
• ECOCAPTURE
45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system
• 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

Locations

Country	Name	City	State
France	ICM / Pitié-Salpêtrière Hospital AP-HP / CIC	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of each behavior from the ethogram	[Provided by the video recording and The Observer NOLDUS software] integer.	45 min
Primary	Frequency of each behavior from the ethogram	[Provided by the video recording and The Observer NOLDUS software] integer.	45 min
Primary	Duration of each behavior from the ethogram	[Provided by the video recording and The Observer NOLDUS software] integer.	45 min
Primary	Number of different behaviors	[Provided by the video recording and The Observer NOLDUS software] integer.	45 min
Primary	Activity classes	[Provided by the MOVE MOVISENS sensor] lying, sitting, ...	45 min
Primary	Body positions	[Provided by the MOVE MOVISENS sensor] lying left, ...	45 min
Primary	Energy expenditure	[Provided by the MOVE MOVISENS sensor] kcal.	45 min
Primary	MET	[Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task: MET level.	45 min
Primary	Steps	[Provided by the MOVE MOVISENS sensor] Counting steps.	45 min
Primary	Acceleration intensity	[Provided by the MOVE MOVISENS sensor] g.	45 min
Primary	Pupil Diameter x	[Provided by the eye-tracking glasses SMI ETG 2w] mm.	10 min
Primary	Pupil Diameter y	[Provided by the eye-tracking glasses SMI ETG 2w] mm.	10 min
Secondary	ICM_APATHY_TASKS	ICM_APATHY_TASKS global score	At day 1
Secondary	MMSE	[Mini Mental State Exam] MMSE global score	At day 1
Secondary	MATTIS	[Mattis Dementia Rating Scale ] MATTIS global score	At day 1
Secondary	NART	[National Adult Reading Test] NART IQ (global score)	At day 1
Secondary	BREF (FAB english)	[Frontal Assessment Battery] BREF global score	At day 1
Secondary	HAYLING	[Hayling Sentence Completion test] ] HAYLING global score	At day 1
Secondary	HAD	[Hospital Anxiety and Depression Scale] ]HAD global score	At day 1
Secondary	Gray matter volume	[MRI analysis- Brain segmentation] mm3	At day 2
Secondary	White matter volume	[MRI analysis- Brain segmentation] mm3	At day 2
Secondary	Cerebral Spinal Fluid volume	[MRI analysis- Brain segmentation] mm3	At day 2
Secondary	Brain lesion localization	[MRI analysis- Brain segmentation] Talairach x,y,z coordinates	At day 2
Secondary	IL-6	Hormonal result [Interleukin-6] pg/mL	At day 1
Secondary	Leptin	Hormonal result [Leptin] ng/mL	At day 1
Secondary	Adiponectin	Hormonal result [Blood adiponectin level)] mg/L	At day 1
Secondary	Insulin	Hormonal result [Fasting Insulin] mUI/L	At day 1
Secondary	C-Peptide	Diabetic result [Fasting C-Peptide level] µg/L	At day 1
Secondary	FPG	Diabetic result [Fasting Plasma Glucose] mmol/L	At day 1
Secondary	HbA1C	Diabetic result [Glycated Hemoglobin] %	At day 1
Secondary	K+	Ionogram result [Potassium] mmol/L	At day 1
Secondary	Uric acid	Ionogram result [Uric acid] µmol/L	At day 1
Secondary	Creatinine	Ionogram result [Creatinine] µmol/L	At day 1
Secondary	Total Protein	Ionogram result [Total protein] g/L	At day 1
Secondary	CRP	Inflammatory result [C-reactive protein] mG/L	At day 1
Secondary	AST	Hepatic result [Aspartate aminotransferase] U/L	At day 1
Secondary	ALT	Hepatic result [Alanine aminotransferase] U/L	At day 1
Secondary	GGT	Hepatic result [Gamma-glutamyltransferase] U/L	At day 1
Secondary	Cholesterol	Lipidic result [Total cholesterol] mmol/L	At day 1
Secondary	Triglycerides	Lipidic result [Triglycerides] mmol/L	At day 1
Secondary	HDL cholesterol	Lipidic result [High-density lipoprotein cholesterol] mmol/L	At day 1
Secondary	LDL cholesterol	Lipidic result [Low-density lipoprotein cholesterol] mmol/L	At day 1
Secondary	Glycerol	Lipidic result [Plasma glycerol concentration] mmol/L	At day 1
Secondary	FFAs	Lipidic result [Plasma free fatty acids] mmol/L	At day 1
Secondary	TSH	Thyroid result [Thyroid-stimulating hormone blood test] mmol/L	At day 1
Secondary	DAS	[Dimensional Apathy Scale] DAS global score	At day 1
Secondary	STARKSTEIN (SAS)	[Starkstein Apathy Scale (SAS)] SAS global score	At day 1
Secondary	MADRS	[Montgomery-Åsberg Depression Rating Scale] MADRS global score	At day 1
Secondary	EBI	[Eating Behavior Inventory] EBI global score	At day 1
Secondary	ACDD	[Autoévaluation des Comportements Dopamine Dépendants] ACDD answers	At day 1
Secondary	QUIP	[Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease] QUIP answers	At day 1
Secondary	BIS-11	[Barratt Impulsiveness Scale] BIS-11 global score	At day 1
Secondary	Mini-SEA	[Mini Social cognition and Emotional Assesment] Mini-SEA global score	At day 1
Secondary	STROOP	[STROOP Test] STROOP global score	At day 1
Secondary	ECMP	[Evaluation Comportementale dans la Maladie de Parkinson] ECMP answers	At day 1
Secondary	QUIP-RS	[Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale] QUIP-RS global score	At day 1