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

October 31, 2017 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of each behavior from the ethogram
Time Frame: 45 min
[Provided by the video recording and The Observer NOLDUS software]
45 min
Frequency of each behavior from the ethogram
Time Frame: 45 min
[Provided by the video recording and The Observer NOLDUS software]
45 min
Duration of each behavior from the ethogram
Time Frame: 45 mn
[Provided by the video recording and The Observer NOLDUS software]
45 mn
Number of different behaviors
Time Frame: 45 mn
[Provided by the video recording and The Observer NOLDUS software]
45 mn
Activity classes
Time Frame: 45 mn
[Provided by the MOVE MOVISENS sensor] lying, sitting, ...
45 mn
Body positions
Time Frame: 45 mn
[Provided by the MOVE MOVISENS sensor] lying left, ...
45 mn
Energy expenditure
Time Frame: 45 mn
[Provided by the MOVE MOVISENS sensor] kcal.
45 mn
MET
Time Frame: 45 mn
[Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task. MET level.
45 mn
Steps
Time Frame: 45 mn
[Provided by the MOVE MOVISENS sensor] Counting steps.
45 mn
Activity intensity
Time Frame: 45 mn
[Provided by the MOVE MOVISENS sensor] g.
45 mn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Richard LEVY, PhD, MD, INSERM UMR_S 1127, ICM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2015

Primary Completion (Actual)

October 2, 2015

Study Completion (Actual)

October 2, 2015

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C15-14
  • 2015-A0087-42 (Registry Identifier: RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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