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

June 3, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • CIC de Neurosciences, ICM, hôpital de la Pitiè Salpétrière

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Frontotemporal Dementia

Clinical Trials on Evaluation of Apathy Close to Real Life Situation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings