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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03272230
Other study ID # C16-87
Secondary ID 2017-A00416-47
Status Recruiting
Phase N/A
First received
Last updated
Start date September 6, 2017
Est. completion date February 28, 2022

Study information

Verified date March 2019
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Bénédicte M BATRANCOURT, PhD
Phone (33-6) 60 44 79 79
Email benedicte.batrancourt@upmc.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Apathy can be defined as a quantitative reduction of voluntary or goal-directed behavior.

So, the investigators propose a behavioral approach for assessing apathy, to obtain a quantifiable and objective signature of reduced goal-directed behavior by directly observing a patient in a real-life situation.

ECOCAPTURE consists of a multi-step scenario in a functional exploration platform equipped with data acquisition system based on video and sensors that track a participant's behavior.

The primary objective of this trial is to create a diagnostic tool for apathy, based on the video and sensors metrics.

A secondary objective of this trial is to validate a new experimental task (ICM_APATHY_TASKS) to test independently three main presumed mechanisms of apathy (motivation, cognitive inertia and coupling between motivation and action).

Another secondary objective aims to specify the pathophysiological mechanisms of apathy, corresponding to cognitive and behavioral processes, neural bases and neurohormonal mechanisms. The definition of pathophysiological mechanisms will allow the classification of apathetic patients (or several forms of apathy) and indicate which mechanism (s) best explains the apathy in a given patient.


Description:

A pilot study ECOCAPTURE (ClinicalTrials.gov/NCT02496312, 2015) applied to a group of participants with the behavioural variant of frontotemporal lobar degeneration (bvFTLD) matched for age, gender and level of education to healthy participants (n=7 per group). This pilot validated the concept of ECOCAPTURE.

The purpose of this trial is to continue the implementation of the ECOCAPTURE tool, extending it to three pathological models: bvFTLD, Parkinson's disease and depression.

The objectives aim to assess behavior directed towards a goal and identify apathy, analyze data to obtain a behavioral signature of apathy and to produce more finely differentiated apathetic patients profiles by specifying the pathophysiological mechanisms (cognitive mechanisms, as well as the neural bases and the neuro-hormonal mechanisms) underlying apathy.

The investigators use multimodal recording tools to track behavior. A multiple-camera system is set up with video coverage of the whole room. A sensor (Move II, Movisens, Karlsruhe, Germany) fixed to the subject's hip, records data such as 3D acceleration, barometric pressure and temperature. From these data, secondary parameters like activity class, body position, steps, energy expenditure and metabolic equivalents are calculated. Video data analysis is performed with The Observer XT software (Noldus, Wageningen, The Netherlands) using an ethogram to identify the frequency and duration of behaviors. For 10 min, during the experimental session, participants ware eye-tracking glasses (ETG 2w, SMI, Teltow, Germany) that record natural gaze behavior.

Metrics built from raw data (video, sensors) are analyzed to reveal a behavioral signature of apathy, highlighting a quantitative reduction in goal-directed behavior.

The study takes place on two visits (one per day). It consists of the observation phase, a neuropsychological assessment, experimental tasks, some of which are computerized, an MRI examination and finally a blood test.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date February 28, 2022
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 85 Years
Eligibility 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

Study Design


Intervention

Behavioral:
ECOCAPTURE
45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system
Cognitive and Behavioral experimental tasks
Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions
Diagnostic Test:
Neuropsychological assessment
MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS
Behavioral:
ICM_APATHY_TASKS
Apathy experimental task
Other:
MRI
T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI
Biological:
Neurohormonal mechanisms
Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
Diagnostic Test:
Supplementary Neuropsychological Assessment - Parkinson's Disease
ACDD / QUIP / BIS-11 / ECMP / QUIP-RS

Locations

Country Name City State
France ICM / Pitié-Salpêtrière Hospital AP-HP / CIC Paris

Sponsors (1)

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

Country where clinical trial is conducted

France, 

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] integer. 45 min
Primary Frequency of each behavior from the ethogram [Provided by the video recording and The Observer NOLDUS software] integer. 45 min
Primary Duration of each behavior from the ethogram [Provided by the video recording and The Observer NOLDUS software] integer. 45 min
Primary Number of different behaviors [Provided by the video recording and The Observer NOLDUS software] integer. 45 min
Primary Activity classes [Provided by the MOVE MOVISENS sensor] lying, sitting, ... 45 min
Primary Body positions [Provided by the MOVE MOVISENS sensor] lying left, ... 45 min
Primary Energy expenditure [Provided by the MOVE MOVISENS sensor] kcal. 45 min
Primary MET [Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task: MET level. 45 min
Primary Steps [Provided by the MOVE MOVISENS sensor] Counting steps. 45 min
Primary Acceleration intensity [Provided by the MOVE MOVISENS sensor] g. 45 min
Primary Pupil Diameter x [Provided by the eye-tracking glasses SMI ETG 2w] mm. 10 min
Primary Pupil Diameter y [Provided by the eye-tracking glasses SMI ETG 2w] mm. 10 min
Secondary ICM_APATHY_TASKS ICM_APATHY_TASKS global score At day 1
Secondary MMSE [Mini Mental State Exam] MMSE global score At day 1
Secondary MATTIS [Mattis Dementia Rating Scale ] MATTIS global score At day 1
Secondary NART [National Adult Reading Test] NART IQ (global score) At day 1
Secondary BREF (FAB english) [Frontal Assessment Battery] BREF global score At day 1
Secondary HAYLING [Hayling Sentence Completion test] ] HAYLING global score At day 1
Secondary HAD [Hospital Anxiety and Depression Scale] ]HAD global score At day 1
Secondary Gray matter volume [MRI analysis- Brain segmentation] mm3 At day 2
Secondary White matter volume [MRI analysis- Brain segmentation] mm3 At day 2
Secondary Cerebral Spinal Fluid volume [MRI analysis- Brain segmentation] mm3 At day 2
Secondary Brain lesion localization [MRI analysis- Brain segmentation] Talairach x,y,z coordinates At day 2
Secondary IL-6 Hormonal result [Interleukin-6] pg/mL At day 1
Secondary Leptin Hormonal result [Leptin] ng/mL At day 1
Secondary Adiponectin Hormonal result [Blood adiponectin level)] mg/L At day 1
Secondary Insulin Hormonal result [Fasting Insulin] mUI/L At day 1
Secondary C-Peptide Diabetic result [Fasting C-Peptide level] µg/L At day 1
Secondary FPG Diabetic result [Fasting Plasma Glucose] mmol/L At day 1
Secondary HbA1C Diabetic result [Glycated Hemoglobin] % At day 1
Secondary K+ Ionogram result [Potassium] mmol/L At day 1
Secondary Uric acid Ionogram result [Uric acid] µmol/L At day 1
Secondary Creatinine Ionogram result [Creatinine] µmol/L At day 1
Secondary Total Protein Ionogram result [Total protein] g/L At day 1
Secondary CRP Inflammatory result [C-reactive protein] mG/L At day 1
Secondary AST Hepatic result [Aspartate aminotransferase] U/L At day 1
Secondary ALT Hepatic result [Alanine aminotransferase] U/L At day 1
Secondary GGT Hepatic result [Gamma-glutamyltransferase] U/L At day 1
Secondary Cholesterol Lipidic result [Total cholesterol] mmol/L At day 1
Secondary Triglycerides Lipidic result [Triglycerides] mmol/L At day 1
Secondary HDL cholesterol Lipidic result [High-density lipoprotein cholesterol] mmol/L At day 1
Secondary LDL cholesterol Lipidic result [Low-density lipoprotein cholesterol] mmol/L At day 1
Secondary Glycerol Lipidic result [Plasma glycerol concentration] mmol/L At day 1
Secondary FFAs Lipidic result [Plasma free fatty acids] mmol/L At day 1
Secondary TSH Thyroid result [Thyroid-stimulating hormone blood test] mmol/L At day 1
Secondary DAS [Dimensional Apathy Scale] DAS global score At day 1
Secondary STARKSTEIN (SAS) [Starkstein Apathy Scale (SAS)] SAS global score At day 1
Secondary MADRS [Montgomery-Åsberg Depression Rating Scale] MADRS global score At day 1
Secondary EBI [Eating Behavior Inventory] EBI global score At day 1
Secondary ACDD [Autoévaluation des Comportements Dopamine Dépendants] ACDD answers At day 1
Secondary QUIP [Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease] QUIP answers At day 1
Secondary BIS-11 [Barratt Impulsiveness Scale] BIS-11 global score At day 1
Secondary Mini-SEA [Mini Social cognition and Emotional Assesment] Mini-SEA global score At day 1
Secondary STROOP [STROOP Test] STROOP global score At day 1
Secondary ECMP [Evaluation Comportementale dans la Maladie de Parkinson] ECMP answers At day 1
Secondary QUIP-RS [Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale] QUIP-RS global score At day 1
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