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Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated. (ECOCAPTURE)

Primary Purpose

Apathy, Behavior, Frontotemporal Dementia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Evaluation of Apathy Close to Real Life Situation
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Apathy focused on measuring Apathy, Goal-directed behavior, Quantitative evaluation, Sensor, Ethogram

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of Frontotemporal Dementia (FTD) according to diagnostic criteria reported by Rascovsky et al. (2011).
  • Understanding of the instructions and capacity to realize the cognitive tasks.
  • Capacity to read, to understand and to sign legal document of information
  • Capacity for informed consent for research, capacity to sign consent
  • MMSE score > 20
  • Absence of other cerebral pathology.
  • Absence of psychiatric disease interfering with the assessment of the tests
  • Absence of excessive psychotropic use
  • Access to National Healthcare Insurance
  • Accompanied with a caregiver

Exclusion Criteria:

  • Excessive psychotropic use
  • Incapacity or refusal to realize the experimental tasks
  • Subject deprived of freedom by an administrative or court order
  • Subject under legal protective measure.
  • Incapacity for informed consent for research
  • Participation in another biomedical research
  • Airway obstruction risk
  • Reduction of activity not attributable to another chronic pathological condition

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ECOCAPTURE

    Arm Description

    Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.

    Outcomes

    Primary Outcome Measures

    Occurrence of each behavior from the ethogram
    [Provided by the video recording and The Observer NOLDUS software]
    Frequency of each behavior from the ethogram
    [Provided by the video recording and The Observer NOLDUS software]
    Duration of each behavior from the ethogram
    [Provided by the video recording and The Observer NOLDUS software]
    Number of different behaviors
    [Provided by the video recording and The Observer NOLDUS software]
    Activity classes
    [Provided by the MOVE MOVISENS sensor] lying, sitting, ...
    Body positions
    [Provided by the MOVE MOVISENS sensor] lying left, ...
    Energy expenditure
    [Provided by the MOVE MOVISENS sensor] kcal.
    MET
    [Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task. MET level.
    Steps
    [Provided by the MOVE MOVISENS sensor] Counting steps.
    Activity intensity
    [Provided by the MOVE MOVISENS sensor] g.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 2, 2015
    Last Updated
    October 31, 2017
    Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02496312
    Brief Title
    Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
    Acronym
    ECOCAPTURE
    Official Title
    Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated in Healthy Subjects and Patients With Frontotemporal Dementia. Pilot Phase.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 10, 2015 (Actual)
    Primary Completion Date
    October 2, 2015 (Actual)
    Study Completion Date
    October 2, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to provide relevant quantitative evaluation of apathy close to real life situation by means of a multimodal sensor system integrated.
    Detailed Description
    The investigators try to measure the amount of goal-directed behaviour and to detect the pattern of apathy. The main objective of this pilot phase is to select the variables of goal-directed behaviour from the list of metrics providing by the multimodal acquisition system in healthy subjects and patients with frontotemporal dementia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apathy, Behavior, Frontotemporal Dementia
    Keywords
    Apathy, Goal-directed behavior, Quantitative evaluation, Sensor, Ethogram

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ECOCAPTURE
    Arm Type
    Experimental
    Arm Description
    Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Evaluation of Apathy Close to Real Life Situation
    Intervention Description
    Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
    Primary Outcome Measure Information:
    Title
    Occurrence of each behavior from the ethogram
    Description
    [Provided by the video recording and The Observer NOLDUS software]
    Time Frame
    45 min
    Title
    Frequency of each behavior from the ethogram
    Description
    [Provided by the video recording and The Observer NOLDUS software]
    Time Frame
    45 min
    Title
    Duration of each behavior from the ethogram
    Description
    [Provided by the video recording and The Observer NOLDUS software]
    Time Frame
    45 mn
    Title
    Number of different behaviors
    Description
    [Provided by the video recording and The Observer NOLDUS software]
    Time Frame
    45 mn
    Title
    Activity classes
    Description
    [Provided by the MOVE MOVISENS sensor] lying, sitting, ...
    Time Frame
    45 mn
    Title
    Body positions
    Description
    [Provided by the MOVE MOVISENS sensor] lying left, ...
    Time Frame
    45 mn
    Title
    Energy expenditure
    Description
    [Provided by the MOVE MOVISENS sensor] kcal.
    Time Frame
    45 mn
    Title
    MET
    Description
    [Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task. MET level.
    Time Frame
    45 mn
    Title
    Steps
    Description
    [Provided by the MOVE MOVISENS sensor] Counting steps.
    Time Frame
    45 mn
    Title
    Activity intensity
    Description
    [Provided by the MOVE MOVISENS sensor] g.
    Time Frame
    45 mn

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Frontotemporal Dementia (FTD) according to diagnostic criteria reported by Rascovsky et al. (2011). Understanding of the instructions and capacity to realize the cognitive tasks. Capacity to read, to understand and to sign legal document of information Capacity for informed consent for research, capacity to sign consent MMSE score > 20 Absence of other cerebral pathology. Absence of psychiatric disease interfering with the assessment of the tests Absence of excessive psychotropic use Access to National Healthcare Insurance Accompanied with a caregiver Exclusion Criteria: Excessive psychotropic use Incapacity or refusal to realize the experimental tasks Subject deprived of freedom by an administrative or court order Subject under legal protective measure. Incapacity for informed consent for research Participation in another biomedical research Airway obstruction risk Reduction of activity not attributable to another chronic pathological condition
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard LEVY, PhD, MD
    Organizational Affiliation
    INSERM UMR_S 1127, ICM
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
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    12461757
    Citation
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    Citation
    Pasquier F, Lebert F, Lavenu I, Guillaume B. The clinical picture of frontotemporal dementia: diagnosis and follow-up. Dement Geriatr Cogn Disord. 1999;10 Suppl 1:10-4. doi: 10.1159/000051206.
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    PubMed Identifier
    19713543
    Citation
    Mayo NE, Fellows LK, Scott SC, Cameron J, Wood-Dauphinee S. A longitudinal view of apathy and its impact after stroke. Stroke. 2009 Oct;40(10):3299-307. doi: 10.1161/STROKEAHA.109.554410. Epub 2009 Aug 27.
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    Citation
    Winograd-Gurvich C, Fitzgerald PB, Georgiou-Karistianis N, Bradshaw JL, White OB. Negative symptoms: A review of schizophrenia, melancholic depression and Parkinson's disease. Brain Res Bull. 2006 Oct 16;70(4-6):312-21. doi: 10.1016/j.brainresbull.2006.06.007. Epub 2006 Jul 5.
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    PubMed Identifier
    10678322
    Citation
    Marin RS, Firinciogullari S, Biedrzycki RC. Group differences in the relationship between apathy and depression. J Nerv Ment Dis. 1994 Apr;182(4):235-9. doi: 10.1097/00005053-199404000-00008.
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    Citation
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    Citation
    Czernecki V, Pillon B, Houeto JL, Welter ML, Mesnage V, Agid Y, Dubois B. Does bilateral stimulation of the subthalamic nucleus aggravate apathy in Parkinson's disease? J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):775-9. doi: 10.1136/jnnp.2003.033258.
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