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
About this trial
This is an interventional diagnostic trial for Apathy focused on measuring Apathy, Goal-directed behavior, Quantitative evaluation, Sensor, Ethogram
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
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
NCT ID
NCT02496312
First Posted
July 2, 2015
Last Updated
October 31, 2017
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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:
PubMed Identifier
12461757
Citation
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Results Reference
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10436334
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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Citation
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Citation
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PubMed Identifier
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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
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
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