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ApathyECOCAPTURENCT02496312

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

A study testing Evaluation of Apathy Close to Real Life Situation in people with Apathy and Behavior, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Apathy, Behavior, Frontotemporal Dementia
What is being tested?
Evaluation of Apathy Close to Real Life Situation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteFrance
Study dates
10 Jul 2015to 2 Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CIC de Neurosciences, ICM, hôpital de la Pitiè Salpétrière

    Paris, 75013

Other trials in France

About this study

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.

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.

Read the 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.

Being tested
Evaluation of Apathy Close to Real Life Situation
Keywords
Apathy, Goal-directed behavior, Quantitative evaluation, Sensor, Ethogram
Medical subject headings
Lethargy, Behavior, Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of Apathy Close to Real Life SituationBehavioural

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

Study groups in NCT02496312
Study groupRoleWhat they receive
ECOCAPTUREExperimentalQuantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
Receives: Behavioral: Evaluation of Apathy Close to Real Life Situation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of each behavior from the ethogram

    [Provided by the video recording and The Observer NOLDUS software]

    Measured: 45 min

  2. Frequency of each behavior from the ethogram

    [Provided by the video recording and The Observer NOLDUS software]

    Measured: 45 min

  3. Duration of each behavior from the ethogram

    [Provided by the video recording and The Observer NOLDUS software]

    Measured: 45 mn

  4. Number of different behaviors

    [Provided by the video recording and The Observer NOLDUS software]

    Measured: 45 mn

  5. Activity classes

    [Provided by the MOVE MOVISENS sensor] lying, sitting, ...

    Measured: 45 mn

  6. Body positions

    [Provided by the MOVE MOVISENS sensor] lying left, ...

    Measured: 45 mn

  7. Energy expenditure

    [Provided by the MOVE MOVISENS sensor] kcal.

    Measured: 45 mn

  8. MET

    [Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task. MET level.

    Measured: 45 mn

  9. Steps

    [Provided by the MOVE MOVISENS sensor] Counting steps.

    Measured: 45 mn

  10. Activity intensity

    [Provided by the MOVE MOVISENS sensor] g.

    Measured: 45 mn

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2015 (estimated)
  2. Study start10 Jul 2015
  3. Primary completion2 Oct 2015
  4. Study completion2 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02496312
Sponsor's protocol ID
C15-14
Other IDs
2015-A0087-42
Acronym
ECOCAPTURE
Status last verified
Oct 2017
First submitted
2 Jul 2015
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No

Publications

  • Robert PH, Clairet S, Benoit M, Koutaich J, Bertogliati C, Tible O, Caci H, Borg M, Brocker P, Bedoucha P. The apathy inventory: assessment of apathy and awareness in Alzheimer's disease, Parkinson's disease and mild cognitive impairment. Int J Geriatr Psychiatry. 2002 Dec;17(12):1099-105. doi: 10.1002/gps.755.

    PubMed 12461757

  • 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.

    PubMed 10436334

  • Mayo NE, Fellows LK, Scott SC, Cameron J, Wood-Dauphinee S. A longitudinal view of apathy and its impact after stroke. Stroke. 2009 Oct;40(10):3299-307. doi: 10.1161/STROKEAHA.109.554410. Epub 2009 Aug 27.

    PubMed 19713543

  • Winograd-Gurvich C, Fitzgerald PB, Georgiou-Karistianis N, Bradshaw JL, White OB. Negative symptoms: A review of schizophrenia, melancholic depression and Parkinson's disease. Brain Res Bull. 2006 Oct 16;70(4-6):312-21. doi: 10.1016/j.brainresbull.2006.06.007. Epub 2006 Jul 5.

    PubMed 17027767

  • 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.

    PubMed 10678322

  • Dujardin K, Sockeel P, Delliaux M, Destee A, Defebvre L. The Lille Apathy Rating Scale: validation of a caregiver-based version. Mov Disord. 2008 Apr 30;23(6):845-9. doi: 10.1002/mds.21968.

    PubMed 18307266

  • Lane-Brown AT, Tate RL. Apathy after acquired brain impairment: a systematic review of non-pharmacological interventions. Neuropsychol Rehabil. 2009 Aug;19(4):481-516. doi: 10.1080/09602010902949207.

    PubMed 19533496

  • Czernecki V, Pillon B, Houeto JL, Welter ML, Mesnage V, Agid Y, Dubois B. Does bilateral stimulation of the subthalamic nucleus aggravate apathy in Parkinson's disease? J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):775-9. doi: 10.1136/jnnp.2003.033258.

    PubMed 15897497

  • Le Jeune F, Drapier D, Bourguignon A, Peron J, Mesbah H, Drapier S, Sauleau P, Haegelen C, Travers D, Garin E, Malbert CH, Millet B, Verin M. Subthalamic nucleus stimulation in Parkinson disease induces apathy: a PET study. Neurology. 2009 Nov 24;73(21):1746-51. doi: 10.1212/WNL.0b013e3181c34b34.

    PubMed 19933975

  • Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. doi: 10.1176/jnp.3.3.243.

    PubMed 1821241

  • Levy R, Dubois B. Apathy and the functional anatomy of the prefrontal cortex-basal ganglia circuits. Cereb Cortex. 2006 Jul;16(7):916-28. doi: 10.1093/cercor/bhj043. Epub 2005 Oct 5.

    PubMed 16207933

  • Levy R, Czernecki V. Apathy and the basal ganglia. J Neurol. 2006 Dec;253 Suppl 7:VII54-61. doi: 10.1007/s00415-006-7012-5.

    PubMed 17131230

  • Brown RG, Pluck G. Negative symptoms: the 'pathology' of motivation and goal-directed behaviour. Trends Neurosci. 2000 Sep;23(9):412-7. doi: 10.1016/s0166-2236(00)01626-x.

    PubMed 10941190

  • Muller U, Czymmek J, Thone-Otto A, Von Cramon DY. Reduced daytime activity in patients with acquired brain damage and apathy: a study with ambulatory actigraphy. Brain Inj. 2006 Feb;20(2):157-60. doi: 10.1080/02699050500443467.

    PubMed 16421064

  • Funkiewiez A, Bertoux M, de Souza LC, Levy R, Dubois B. The SEA (Social cognition and Emotional Assessment): a clinical neuropsychological tool for early diagnosis of frontal variant of frontotemporal lobar degeneration. Neuropsychology. 2012 Jan;26(1):81-90. doi: 10.1037/a0025318. Epub 2011 Sep 5.

    PubMed 21895376

Questions about this trial

What is this clinical trial studying?

A study testing Evaluation of Apathy Close to Real Life Situation in people with Apathy and Behavior, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of each behavior from the ethogram (time frame: 45 min). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02496312, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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