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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03272230
Date of registration:	03/08/2017
Prospective Registration:	Yes
Primary sponsor:	Institut National de la Santé Et de la Recherche Médicale, France
Public title:	Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System ECOCAPTURE
Scientific title:	Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease
Date of first enrolment:	September 6, 2017
Target sample size:	135
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03272230
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Bénédicte M BATRANCOURT, PhD
Address:
Telephone:	(33-6) 60 44 79 79
Email:	benedicte.batrancourt@upmc.fr
Affiliation:

Name:	Armelle RAMETTI-LACROUX, PhD
Address:
Telephone:	(33-1) 42 16 55 20
Email:	armelle.ramettilacroux@icm-institute.org
Affiliation:

Name:	Richard LEVY, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Institut National de la Santé Et de la Recherche Médicale, France

Key inclusion & exclusion criteria

Inclusion Criteria:

All groups:

- Ability to give informed consent for study procedures

- Ability to understand study instructions and to realize the cognitive tasks

- Person with health insurance

Patients:

- MMS>20

- Absence of another neurological or psychiatric disease

- Presence of a caregiver

- We will recruit three groups of patients:

- diagnosed with behavioral variant frontotemporal dementia (bvFTD) according to
the Rascovsky criteria (Rascovsky et al. 2011)

- diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992)

- Sub-group 1: Parkinson's disease with Impulse Control Disorders (ICDs)

- Sub-group 2: Parkinson's disease without Impulse Control Disorders (ICDs)

- diagnosed with depression (Major Depressive Disorder, DSM-IV)

Healthy age,sex, education-matched controls:

- MMS>27

- Absence of neurological or psychiatric disease

Exclusion Criteria:

- Standard contraindications to MRI

- Inability to understand study instructions

- Person mentioned in the article L.1121-5 to L. 1121-8 and L. 1122-12 of the French
Public Health Code

Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Apathy

Depressive Symptoms

Frontotemporal Dementia

Parkinson Disease

Intervention(s)

Behavioral: ICM_APATHY_TASKS

Behavioral: ECOCAPTURE

Behavioral: Cognitive and Behavioral experimental tasks

Biological: Neurohormonal mechanisms

Other: MRI

Diagnostic Test: Neuropsychological assessment

Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's Disease

Primary Outcome(s)

Number of different behaviors [Time Frame: 45 min]

Activity classes [Time Frame: 45 min]

MET [Time Frame: 45 min]

Duration of each behavior from the ethogram [Time Frame: 45 min]

Body positions [Time Frame: 45 min]

Frequency of each behavior from the ethogram [Time Frame: 45 min]

Acceleration intensity [Time Frame: 45 min]

Pupil Diameter y [Time Frame: 10 min]

Energy expenditure [Time Frame: 45 min]

Occurrence of each behavior from the ethogram [Time Frame: 45 min]

Pupil Diameter x [Time Frame: 10 min]

Steps [Time Frame: 45 min]

Secondary Outcome(s)

Adiponectin [Time Frame: At day 1]

Leptin [Time Frame: At day 1]

MADRS [Time Frame: At day 1]

Creatinine [Time Frame: At day 1]

HAYLING [Time Frame: At day 1]

Insulin [Time Frame: At day 1]

Mini-SEA [Time Frame: At day 1]

QUIP [Time Frame: At day 1]

STROOP [Time Frame: At day 1]

BREF (FAB english) [Time Frame: At day 1]

Cerebral Spinal Fluid volume [Time Frame: At day 2]

Cholesterol [Time Frame: At day 1]

Glycerol [Time Frame: At day 1]

HAD [Time Frame: At day 1]

GGT [Time Frame: At day 1]

TSH [Time Frame: At day 1]

White matter volume [Time Frame: At day 2]

HbA1C [Time Frame: At day 1]

HDL cholesterol [Time Frame: At day 1]

STARKSTEIN (SAS) [Time Frame: At day 1]

ALT [Time Frame: At day 1]

AST [Time Frame: At day 1]

Brain lesion localization [Time Frame: At day 2]

C-Peptide [Time Frame: At day 1]

CRP [Time Frame: At day 1]

ECMP [Time Frame: At day 1]

IL-6 [Time Frame: At day 1]

QUIP-RS [Time Frame: At day 1]

Total Protein [Time Frame: At day 1]

ACDD [Time Frame: At day 1]

NART [Time Frame: At day 1]

K+ [Time Frame: At day 1]

Triglycerides [Time Frame: At day 1]

Uric acid [Time Frame: At day 1]

EBI [Time Frame: At day 1]

Gray matter volume [Time Frame: At day 2]

BIS-11 [Time Frame: At day 1]

DAS [Time Frame: At day 1]

FFAs [Time Frame: At day 1]

FPG [Time Frame: At day 1]

ICM_APATHY_TASKS [Time Frame: At day 1]

LDL cholesterol [Time Frame: At day 1]

MATTIS [Time Frame: At day 1]

MMSE [Time Frame: At day 1]

Secondary ID(s)

2017-A00416-47

C16-87

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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