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

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ClinicalTrials.gov Identifier: NCT02496312
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Apathy Behavior Frontotemporal Dementia Behavioral: Evaluation of Apathy Close to Real Life Situation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : July 10, 2015
Actual Primary Completion Date : October 2, 2015
Actual Study Completion Date : October 2, 2015


Arm Intervention/treatment
Experimental: ECOCAPTURE
Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
Behavioral: Evaluation of Apathy Close to Real Life Situation
Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.




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]

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

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

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

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

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

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

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

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

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



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02496312


Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Richard LEVY, PhD, MD INSERM UMR_S 1127, ICM
Publications:

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02496312    
Other Study ID Numbers: C15-14
2015-A0087-42 ( Registry Identifier: RCB )
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Apathy
Goal-directed behavior
Quantitative evaluation
Sensor
Ethogram
Additional relevant MeSH terms:
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Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations