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

Not Applicable

Completed

• Conditions: Behavior; Frontotemporal Dementia; Apathy

• Registration Number: NCT02496312
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-07-02
• Study Start: 2015-07-10
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-14
• Primary Completion: 2015-10-02
• Study Completion: 2015-10-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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