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

Behavior Clinical Trial

— ECOCAPTURE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496312
• Other study ID #: C15-14
• Secondary ID: 2015-A0087-42
• Status: Completed
• Phase: N/A
• First received: July 2, 2015
• Last updated: October 31, 2017
• Start date: July 10, 2015
• Est. completion date: October 2, 2015

Study information

• Verified date: October 2017
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2, 2015
• Est. primary completion date: October 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Apathy
• Aphasia, Primary Progressive
• Behavior
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

References & Publications (15)

Brown RG, Pluck G. Negative symptoms: the 'pathology' of motivation and goal-directed behaviour. Trends Neurosci. 2000 Sep;23(9):412-7. Review. — View Citation

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. — View Citation

Dujardin K, Sockeel P, Delliaux M, Destée 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. — View Citation

Funkiewiez A, Bertoux M, de Souza LC, Lévy 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. — View Citation

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. Review. — View Citation

Le Jeune F, Drapier D, Bourguignon A, Péron J, Mesbah H, Drapier S, Sauleau P, Haegelen C, Travers D, Garin E, Malbert CH, Millet B, Vérin 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. — View Citation

Levy R, Czernecki V. Apathy and the basal ganglia. J Neurol. 2006 Dec;253 Suppl 7:VII54-61. Review. — View Citation

Levy R, Dubois B. Apathy and the functional anatomy of the prefrontal cortex-basal ganglia circuits. Cereb Cortex. 2006 Jul;16(7):916-28. Epub 2005 Oct 5. Review. — View Citation

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. — View Citation

Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. Review. — View Citation

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. — View Citation

Müller U, Czymmek J, Thöne-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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jul 5. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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