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

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ClinicalTrials.gov Identifier: NCT03272230
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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 Not Applicable

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  (Clinical Trial)
Estimated 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 : September 6, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : February 28, 2022


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 / ABI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING test / 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 / ABI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING test / 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 without impulse control disorders

Initially especially patients diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992).

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 / ABI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING test / 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: 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 / ABI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING test / 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 with impulse control disorders

Initially especially patients diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992).

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 / ABI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING test / 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




Primary Outcome Measures :
  1. Occurrence of each behavior from the ethogram [ Time Frame: 45 min ]
    [Provided by the video recording and The Observer NOLDUS software] integer.

  2. Frequency of each behavior from the ethogram [ Time Frame: 45 min ]
    [Provided by the video recording and The Observer NOLDUS software] integer.

  3. Duration of each behavior from the ethogram [ Time Frame: 45 min ]
    [Provided by the video recording and The Observer NOLDUS software] integer.

  4. Number of different behaviors [ Time Frame: 45 min ]
    [Provided by the video recording and The Observer NOLDUS software] integer.

  5. Activity classes [ Time Frame: 45 min ]
    [Provided by the MOVE MOVISENS sensor] lying, sitting, ...

  6. Body positions [ Time Frame: 45 min ]
    [Provided by the MOVE MOVISENS sensor] lying left, ...

  7. Energy expenditure [ Time Frame: 45 min ]
    [Provided by the MOVE MOVISENS sensor] kcal.

  8. MET [ Time Frame: 45 min ]
    [Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task: MET level.

  9. Steps [ Time Frame: 45 min ]
    [Provided by the MOVE MOVISENS sensor] Counting steps.

  10. Acceleration intensity [ Time Frame: 45 min ]
    [Provided by the MOVE MOVISENS sensor] g.

  11. Pupil Diameter x [ Time Frame: 10 min ]
    [Provided by the eye-tracking glasses SMI ETG 2w] mm.

  12. Pupil Diameter y [ Time Frame: 10 min ]
    [Provided by the eye-tracking glasses SMI ETG 2w] mm.


Secondary Outcome Measures :
  1. ICM_APATHY_TASKS [ Time Frame: At day 1 ]
    ICM_APATHY_TASKS global score

  2. MMSE [ Time Frame: At day 1 ]
    [Mini Mental State Exam] MMSE global score

  3. MATTIS [ Time Frame: At day 1 ]
    [Mattis Dementia Rating Scale ] MATTIS global score

  4. NART [ Time Frame: At day 1 ]
    [National Adult Reading Test] NART IQ (global score)

  5. BREF (FAB english) [ Time Frame: At day 1 ]
    [Frontal Assessment Battery] BREF global score

  6. HAYLING [ Time Frame: At day 1 ]
    [Hayling Sentence Completion test] ] HAYLING global score

  7. HAD [ Time Frame: At day 1 ]
    [Hospital Anxiety and Depression Scale] ]HAD global score

  8. Gray matter volume [ Time Frame: At day 2 ]
    [MRI analysis- Brain segmentation] mm3

  9. White matter volume [ Time Frame: At day 2 ]
    [MRI analysis- Brain segmentation] mm3

  10. Cerebral Spinal Fluid volume [ Time Frame: At day 2 ]
    [MRI analysis- Brain segmentation] mm3

  11. Brain lesion localization [ Time Frame: At day 2 ]
    [MRI analysis- Brain segmentation] Talairach x,y,z coordinates

  12. IL-6 [ Time Frame: At day 1 ]
    Hormonal result [Interleukin-6] pg/mL

  13. Leptin [ Time Frame: At day 1 ]
    Hormonal result [Leptin] ng/mL

  14. Adiponectin [ Time Frame: At day 1 ]
    Hormonal result [Blood adiponectin level)] mg/L

  15. Insulin [ Time Frame: At day 1 ]
    Hormonal result [Fasting Insulin] mUI/L

  16. C-Peptide [ Time Frame: At day 1 ]
    Diabetic result [Fasting C-Peptide level] µg/L

  17. FPG [ Time Frame: At day 1 ]
    Diabetic result [Fasting Plasma Glucose] mmol/L

  18. HbA1C [ Time Frame: At day 1 ]
    Diabetic result [Glycated Hemoglobin] %

  19. K+ [ Time Frame: At day 1 ]
    Ionogram result [Potassium] mmol/L

  20. Uric acid [ Time Frame: At day 1 ]
    Ionogram result [Uric acid] µmol/L

  21. Creatinine [ Time Frame: At day 1 ]
    Ionogram result [Creatinine] µmol/L

  22. Total Protein [ Time Frame: At day 1 ]
    Ionogram result [Total protein] g/L

  23. CRP [ Time Frame: At day 1 ]
    Inflammatory result [C-reactive protein] mG/L

  24. AST [ Time Frame: At day 1 ]
    Hepatic result [Aspartate aminotransferase] U/L

  25. ALT [ Time Frame: At day 1 ]
    Hepatic result [Alanine aminotransferase] U/L

  26. GGT [ Time Frame: At day 1 ]
    Hepatic result [Gamma-glutamyltransferase] U/L

  27. Cholesterol [ Time Frame: At day 1 ]
    Lipidic result [Total cholesterol] mmol/L

  28. Triglycerides [ Time Frame: At day 1 ]
    Lipidic result [Triglycerides] mmol/L

  29. HDL cholesterol [ Time Frame: At day 1 ]
    Lipidic result [High-density lipoprotein cholesterol] mmol/L

  30. LDL cholesterol [ Time Frame: At day 1 ]
    Lipidic result [Low-density lipoprotein cholesterol] mmol/L

  31. Glycerol [ Time Frame: At day 1 ]
    Lipidic result [Plasma glycerol concentration] mmol/L

  32. FFAs [ Time Frame: At day 1 ]
    Lipidic result [Plasma free fatty acids] mmol/L

  33. TSH [ Time Frame: At day 1 ]
    Thyroid result [Thyroid-stimulating hormone blood test] mmol/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272230


Contacts
Contact: Bénédicte M BATRANCOURT, PhD (33-6) 60 44 79 79 benedicte.batrancourt@upmc.fr
Contact: Armelle Ramettilacroux, Master armelle.ramettilacroux@icm-institute.org

Locations
France
ICM / Pitié-Salpêtrière Hospital AP-HP / CIC Recruiting
Paris, France, 75013
Contact: Armelle Ramettilacroux, Master       armelle.ramettilacroux@icm-institute.org   
Sponsors and Collaborators
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

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03272230     History of Changes
Other Study ID Numbers: C16-87
2017-A00416-47 ( Registry Identifier: RCB )
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Apathy
Goal-directed behavior
Assessment
Diagnosis
Sensor
Ecological condition
Neurological disease

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Depression
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms