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

NCT ID: NCT02496312

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-10

Study Completion Date

2015-10-02

Brief Summary

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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

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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.

Conditions

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Apathy Behavior Frontotemporal Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ECOCAPTURE

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

Group Type EXPERIMENTAL

Evaluation of Apathy Close to Real Life Situation

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard LEVY, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

INSERM UMR_S 1127, ICM

References

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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.

Reference Type BACKGROUND
PMID: 15897497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19933975 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1821241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16207933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17131230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10941190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16421064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21895376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12461757 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10436334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19713543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17027767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10678322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18307266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19533496 (View on PubMed)

Batrancourt B, Lecouturier K, Ferrand-Verdejo J, Guillemot V, Azuar C, Bendetowicz D, Migliaccio R, Rametti-Lacroux A, Dubois B, Levy R. Exploration Deficits Under Ecological Conditions as a Marker of Apathy in Frontotemporal Dementia. Front Neurol. 2019 Aug 28;10:941. doi: 10.3389/fneur.2019.00941. eCollection 2019.

Reference Type RESULT
PMID: 31551908 (View on PubMed)

Tanguy D, Rametti-Lacroux A, Bouzigues A, Saracino D, Le Ber I, Godefroy V, Morandi X, Jannin P, Levy R, Batrancourt B, Migliaccio R; ECOCAPTURE Study Group. Behavioural disinhibition in frontotemporal dementia investigated within an ecological framework. Cortex. 2023 Mar;160:152-166. doi: 10.1016/j.cortex.2022.11.013. Epub 2022 Dec 28.

Reference Type RESULT
PMID: 36658040 (View on PubMed)

Godefroy V, Batrancourt B, Charron S, Bouzigues A, Bendetowicz D, Carle G, Rametti-Lacroux A, Bombois S, Cognat E, Migliaccio R, Levy R. Functional connectivity correlates of reduced goal-directed behaviors in behavioural variant frontotemporal dementia. Brain Struct Funct. 2022 Dec;227(9):2971-2989. doi: 10.1007/s00429-022-02519-5. Epub 2022 Jun 25.

Reference Type RESULT
PMID: 35751676 (View on PubMed)

Godefroy V, Batrancourt B, Charron S, Bouzigues A, Sezer I, Bendetowicz D, Carle G, Rametti-Lacroux A, Bombois S, Cognat E, Migliaccio R, Levy R. Disentangling Clinical Profiles of Apathy in Behavioral Variant Frontotemporal Dementia. J Alzheimers Dis. 2022;90(2):639-654. doi: 10.3233/JAD-220370.

Reference Type RESULT
PMID: 36155506 (View on PubMed)

Other Identifiers

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2015-A0087-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

C15-14

Identifier Type: -

Identifier Source: org_study_id

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