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ApathyECOCAPTURENCT03272230

Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System

A study testing ECOCAPTURE, Cognitive and Behavioral experimental tasks and Neuropsychological assessment in people with Apathy and Behavioral Variant Frontotemporal Dementia (bvFTD), 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

Apathy is defined as a quantitative reduction in voluntary and goal-directed behavior. To address this, the investigators propose an ethological approach to assess apathy objectively and quantitatively by observing patients in real-life situations. Read more about this study

Who is it for?
Ages 40 to 85 yearsHealthy volunteers can take part
What is being tested?
ECOCAPTURE, Cognitive and Behavioral experimental tasks and Neuropsychological assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteFrance
Study dates
6 Sep 2017to 8 May 2024
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 40 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Eligibility Criteria for All Groups:
  • Demonstrates the ability to provide informed consent for participation in the study.
  • Capable of understanding study instructions and performing cognitive tasks as required.
  • Enrolled in a valid health insurance plan.
  • Eligibility Criteria for Patients:
  • Mini-Mental State Examination (MMSE): Score ≥ 17.
Show all 14Show fewer
  • Medical History: Absence of any other neurological or psychiatric conditions.
  • Caregiver Requirement: Must have a caregiver present.
  • Patient Groups:
  • Diagnosed with behavioral variant frontotemporal dementia (bvFTD) based on the Rascovsky criteria (Rascovsky et al., 2011).
  • Diagnosed with Major Depressive Disorder (MDD) according to DSM-IV criteria.
  • Eligibility Criteria for Healthy Age-, Sex-, and Education-Matched Controls:
  • Mini-Mental State Examination (MMSE): Score > 27.
  • Medical History: No history of neurological or psychiatric disorders.

Who cannot join

  • MRI Contraindications: Standard contraindications to magnetic resonance imaging (e.g., pacemaker, metallic implants, claustrophobia).
  • Cognitive Barriers: Inability to comprehend study instructions.
  • Legal Restrictions: Individuals referenced in Articles L.1121-5 to L.1121-8 and L.1122-12 of the French Public Health Code.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Paris Brain Institute / ICM / Pitié-Salpêtrière Hospital AP-HP / CIC

    Paris, 75013

Other trials in France

About this study

Official title: Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease

Apathy is defined as a quantitative reduction in voluntary and goal-directed behavior. To address this, the investigators propose an ethological approach to assess apathy objectively and quantitatively by observing patients in real-life situations.

The ECOCAPTURE paradigm involves a structured, multi-step scenario conducted in a functional exploration platform. This platform is equipped with an advanced data acquisition system integrating video recordings and sensors to precisely monitor and analyze participants' behavior.

Read more

Primary objective:

Develop a diagnostic tool for apathy using metrics derived from video recordings and sensor data. This tool aims to provide objective measures to identify and quantify apathy.

Secondary Objectives:

  • Validation of ICM_APATHY_TASKS: This novel experimental task is designed to evaluate three primary mechanisms thought to underlie apathy: Motivation, Cognitive inertia (difficulty initiating tasks), The interaction between motivation and action execution.
  • Identification of the pathophysiological mechanisms of apathy by investigate the cognitive, behavioral, neural, and neurohormonal underpinnings of apathy.

This will enable the classification of apathetic patients into subtypes (or several forms of apathy) based on the dominant mechanisms and provide insights into which processes best explain apathy in individual cases.

This innovative framework aims to deepen the understanding of apathy, improve diagnostic precision, and pave the way for tailored interventions.

Read the detailed description

A pilot study, ECOCAPTURE (ClinicalTrials.gov/NCT02496312, 2015), was conducted with participants diagnosed with the behavioral variant of frontotemporal dementia (bvFTD) matched for age, gender, and education level with healthy controls (n=7 per group). This study successfully validated the feasibility and conceptual framework of the ECOCAPTURE approach.

The aim of this trial is to further develop and expand the ECOCAPTURE tool by applying it to a larger population, including individuals with the behavioral variant of frontotemporal dementia (bvFTD) and healthy control participants.

The objectives of this study are to evaluate goal-directed behavior and identify apathy by analyzing data to establish a behavioral signature of apathy. Additionally, the study seeks to refine patient profiles by delineating the pathophysiological mechanisms underlying apathy, including cognitive processes, neural substrates, and neurohormonal pathways.

The experiments take place on an experimental platform dedicated to the functional exploration of human behavior (PRISME, ICM core facility, Salpêtrière Hospital, Paris, France), to assess behavior under ecological conditions. The ECOCAPTURE paradigm mimics a naturalistic situation (i.e., waiting comfortably in a waiting room). Participants undergo a structured 45-minute controlled scenario, during which their behavior is systematically monitored to evaluate apathy and disinhibition.

The PRISME platform is transformed into a furnished waiting room containing specific objects that provides opportunities to interact with the environment. The platform is equipped with a six-ceiling camera system (not hidden) covering the entire waiting room. The Media Recorder® software (NOLDUS Information Technology, Wageningen, the Netherlands) facilitates simultaneous video recordings from multiple cameras, ensuring synchronized capture across different viewpoints for comprehensive behavioral analysis. During the experiment, individuals' behavior is video-recorded, and their movement acceleration is measured using a wireless body sensor (Move II® triaxial accelerometer, Movisens GmbH, Karlsruhe, Germany) worn on the right hip. An eye-tracking system (SMI Eye Tracking Glasses 2 Wireless, ®SensoMotoric Instruments, Teltow, Germany / Tobii Pro Glasses 3, ®Tobii AB, Danderyd, Sweden) is added to the multimodal recording system, and the subjects wear eye-tracking glasses for a 7-minute period during the 45-minute experimental session. The subjects are informed at the time of initial consent that their behavior would be tracked and recorded by video cameras located in the room.

Video data analysis is performed with The Observer XT software (Version 14.0, NOLDUS, Wageningen, The Netherlands) to identify the frequency and duration of behaviors. Behavioral metrics are obtained by behavioral coding from 45-minute video footage for each individual. Behavioral coding data is collected through the continuous sampling method, to identify all occurrences of behaviors and their duration. Behavioral coding is conducted based on two ethograms - the ECOCAPTURE apathy ethogram, the ECOCAPTURE disinhibition ethogram - (Batrancourt et al. 2022, "The ECOCAPTURE ethograms: apathy ethogram and disinhibition ethogram", Mendeley Data, V2, doi: 10.17632/mv8hndcd95.2) The ECOCAPTURE apathy ethogram includes behaviors divided in two behavioral categories: Motor patterns, Activity states. The ECOCAPTURE disinhibition ethogram includes behaviors divided in three disinhibition categories: Compulsivity, Impulsivity, Social disinhibition.

Metrics built from collected data (video, sensors) are analyzed to reveal a behavioral signature of apathy.

The study consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection.

Being tested
ECOCAPTURE, Cognitive and Behavioral experimental tasks, Neuropsychological assessment, ICM_APATHY_TASKS, MRI
Keywords
Apathy, Goal-directed behavior, Assessment, Diagnosis, Sensor, Ecological condition, Neurological disease, Dementia, Human ethology, Behavioral sensing, Accelerometer, Disinhibition, ECOCAPTURE
Medical subject headings
Lethargy, Disease, Nervous System Diseases, Dementia

What participants receive

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

  • ECOCAPTUREBehavioural

    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 tasksBehavioural

    Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions

  • Neuropsychological assessmentDiagnostic test

    STARKSTEIN APATHY SCALE (SAS) / DAS / MMSE / MADRS / EBI / MINI-SEA / FAB / HAD / MATTIS / HAYLING / STROOP / Verbal Span / Lexical verbal fluency / TMT / CDRS

  • ICM_APATHY_TASKSBehavioural

    Apathy experimental task

  • MRIOther

    T1 / T2 / rs-fMRI / MS-DWI

  • Neurohormonal mechanismsBiological

    Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage

Study groups in NCT03272230
Study groupRoleWhat they receive
Arm 1ExperimentalThe Arm consists of two separate visits, each occurring on a different day, and includes the following components: the ECOCAPTURE observation phase in ecological conditions, a comprehensive neuropsychological assessment, a series of experimental tasks (some of which are computer-based), an MRI scan (including T1, T2, rs-fMRI, and MS-DWI), and a blood sample collection.
Receives: Behavioral: ECOCAPTURE; Behavioral: Cognitive and Behavioral experimental tasks; Diagnostic Test: Neuropsychological assessment; Behavioral: ICM_APATHY_TASKS; Other: MRI; Biological: Neurohormonal mechanisms
Healthy volunteersActive comparatorNot described
Receives: Behavioral: ECOCAPTURE; Behavioral: Cognitive and Behavioral experimental tasks; Diagnostic Test: Neuropsychological assessment; Behavioral: ICM_APATHY_TASKS; Other: MRI; Biological: Neurohormonal mechanisms

What is being measured

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

  1. Frequency of each behavior in the ECOCAPTURE ethogram

    [Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram] integer.

    .

    Measured: 45 minutes

  2. Occurrence of each behavior in the ECOCAPTURE ethogram

    [Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram] integer.

    .

    Measured: 45 minutes

  3. Duration of each behavior in the ECOCAPTURE ethogram

    [Tracking specific behaviors as outlined in the ECOCAPTURE ethogram. Behavioral metrics are derived from coding the behaviors observed in 45-minute video footage, based on the structured ethogram] integer.

    .

    Measured: 45 minutes

  4. Activity classes

    [Provided by the accelerometer sensor] Activity class: Indicates the physical position of the subject (unknown position = 0, lying down = 1, sitting/standing = 2, vertical movement upwards = 4, fast movement = 5, vertical movement downwards = 6, walking = 7)

    Measured: 45 minutes

  5. Body positions

    [Provided by the accelerometer sensor] Body position: Specifies the characteristics of the lying position (unknown position = 0, lying on the back = 1, lying on the left side = 2, lying on the stomach = 3, lying on the right side = 4, getting up = 5).

    Measured: 45 minutes

  6. Steps

    [Provided by the accelerometer sensor] Counting steps.

    Measured: 45 minutes

  7. Energy expenditure

    [Provided by the accelerometer sensor] Energy expenditure during activity phases. kcal.

    Measured: 45 minutes

  8. MET

    [Provided by the accelerometer sensor] The Metabolic Equivalent of Task: MET level.

    Measured: 45 minutes

  9. Acceleration intensity

    [Provided by the accelerometer sensor] g.

    Measured: 45 minutes

  10. Pupil Diameter x,y

    [Provided by the eye-tracking glasses] mm, mm.

    Measured: 7 minutes

  11. Ocular events

    [Provided by the eye-tracking glasses] Saccades, Fixations and Blink frequency.

    Measured: 7 minutes

  12. Gaze points

    [Provided by the eye-tracking glasses] Individual records of the participant's gaze at any given moment

    Measured: 7 minutes

Secondary outcomes (41)

  1. STARKSTEIN (SAS)

    [Part of the neuropsychological assessment - Starkstein Apathy Scale] SAS global score

    Measured: 10 minutes

  2. DAS

    [Part of the neuropsychological assessment] - Dimensional Apathy Scale - DAS global score - DAS initiation score - DAS executive score - DAS emotional score.

    Measured: 10 minutes

  3. ICM_APATHY_TASKS

    ICM_APATHY_TASKS global score. [The ICM_APATHY_TASKS test three main presumed mechanisms of apathy: lack of motivation, cognitive inertia, and the decoupling between motivation and action. These tasks integrate two orthogonal dimensions: 1/ The cognitive dimension: modulation of the level of cognitive strategy (to study cognitive inertia); 2/ The motivational dimension: modulation of the reward at stake (to study lack of motivation)].

    Measured: 60 minutes

  4. MMSE

    [Part of the neuropsychological assessment] - Mini Mental State Exam - MMSE global score

    Measured: 5 minutes

  5. MADRS

    [Part of the neuropsychological assessment] - Montgomery-Åsberg Depression Rating Scale - MADRS global score

    Measured: 10 minutes

  6. EBI

    [Part of the neuropsychological assessment] - Eating Behavior Inventory - EBI scores. [Food behavior questionnaire. This refers to an assessment tool designed to evaluate a person's eating behaviors and identify potential risks, such as choking or aspiration, during eating].

    Measured: 15 minutes

  7. MATTIS

    [Part of the neuropsychological assessment] - Mattis Dementia Rating Scale - MATTIS global score

    Measured: 20 minutes

  8. FAB

    [Part of the neuropsychological assessment] - Frontal Assessment Battery - FAB global score [French version: BREF].

    Measured: 10 minutes

  9. HAYLING

    [Part of the neuropsychological assessment] - Hayling Sentence Completion test - HAYLING B-A score

    Measured: 15 minutes

  10. HAD

    [Part of the neuropsychological assessment] Hospital Anxiety and Depression Scale - HAD global score

    Measured: 10 minutes

  11. STROOP

    [Part of the neuropsychological assessment] - STROOP - STROOP global score

    Measured: 3 minutes

  12. Mini-SEA

    [Part of the neuropsychological assessment] - Mini Social cognition and Emotional Assesment - Mini-SEA global score

    Measured: 20 minutes

  13. Verbal Span / Lexical verbal fluency

    [Part of the neuropsychological assessment] - Verbal Span / Lexical verbal fluency - Verbal scores

    Measured: 7 minutes

  14. CDRS

    [Part of the neuropsychological assessment] - Clinical Dementia Rating (CDR) Scale - CDRS global score

    Measured: 5 minutes

  15. Gray matter volume

    [MRI analysis- Brain segmentation] mm3

    Measured: MRI exam: 48 minutes

  16. White matter volume

    [MRI analysis- Brain segmentation] mm3

    Measured: MRI exam: 48 minutes

  17. Cortical Thickness

    [MRI analysis- Brain segmentation] mm

    Measured: MRI exam: 48 minutes

  18. Resting-State Connectivity

    [fMRI analysis] - strength and significance of the connection between different regions.

    Measured: MRI exam: 48 minutes

  19. IL-6

    Hormonal result [Interleukin-6] pg/mL

    Measured: Blood sample collection - 30 minutes

  20. Leptin

    Hormonal result [Leptin] ng/mL

    Measured: Blood sample collection - 30 minutes

  21. Adiponectin

    Hormonal result [Blood adiponectin level)] mg/L

    Measured: Blood sample collection - 30 minutes

  22. Insulin

    Hormonal result [Fasting Insulin] mUI/L

    Measured: Blood sample collection - 30 minutes

  23. C-Peptide

    Diabetic result [Fasting C-Peptide level] µg/L

    Measured: Blood sample collection - 30 minutes

  24. FPG

    Diabetic result [Fasting Plasma Glucose] mmol/L

    Measured: Blood sample collection - 30 minutes

  25. HbA1C

    Diabetic result [Glycated Hemoglobin] %

    Measured: Blood sample collection - 30 minutes

  26. Sodium

    Ionogram result [Sodium] mmol/L

    Measured: Blood sample collection - 30 minutes

  27. K+

    Ionogram result [Potassium] mmol/L

    Measured: Blood sample collection - 30 minutes

  28. Uric acid

    Ionogram result [Uric acid] µmol/L

    Measured: Blood sample collection - 30 minutes

  29. Creatinine

    Ionogram result [Creatinine] µmol/L

    Measured: Blood sample collection - 30 minutes

  30. Total Protein

    Ionogram result [Total protein] g/L

    Measured: Blood sample collection - 30 minutes

  31. CRP

    Inflammatory result [C-reactive protein] mG/L

    Measured: Blood sample collection - 30 minutes

  32. AST

    Hepatic result [Aspartate aminotransferase] U/L

    Measured: Blood sample collection - 30 minutes

  33. ALT

    Hepatic result [Alanine aminotransferase] U/L

    Measured: Blood sample collection - 30 minutes

  34. GGT

    Hepatic result [Gamma-glutamyltransferase] U/L

    Measured: Blood sample collection - 30 minutes

  35. Cholesterol

    Lipidic result [Total cholesterol] mmol/L

    Measured: Blood sample collection - 30 minutes

  36. Triglycerides

    Lipidic result [Triglycerides] mmol/L

    Measured: Blood sample collection - 30 minutes

  37. HDL cholesterol

    Lipidic result [High-density lipoprotein cholesterol] mmol/L

    Measured: Blood sample collection - 30 minutes

  38. LDL cholesterol

    Lipidic result [Low-density lipoprotein cholesterol] mmol/L

    Measured: Blood sample collection - 30 minutes

  39. Glycerol

    Lipidic result [Plasma glycerol concentration] mmol/L

    Measured: Blood sample collection - 30 minutes

  40. FFAs

    Lipidic result [Plasma free fatty acids] mmol/L

    Measured: Blood sample collection - 30 minutes

  41. TSH

    Thyroid result [Thyroid-stimulating hormone blood test] mmol/L

    Measured: Blood sample collection - 30 minutes

Timeline

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

  1. First posted5 Sep 2017
  2. Study start6 Sep 2017
  3. Primary completion8 Dec 2023
  4. Study completion8 May 2024

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03272230
Sponsor's protocol ID
C16-87
Other IDs
2017-A00416-47
Acronym
ECOCAPTURE
Status last verified
Nov 2024
First submitted
3 Aug 2017
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The scientific leaders of the ECOCAPTURE research project aim to participate in international OPEN DATA initiatives. In this context, the following fully anonymized data will be made available to the scientific community: * Data collected from the accelerometer-type sensor. * Data on the subject's ocular behavior (events such as saccades or fixations) from the eye-tracking sensor. The videos from the glasses will not be shared. * Behavioral data from video coding based on the ECOCAPTURE ethogram. The videos will not be shared. * Scores from the neuropsychological assessment * MRI data * Blood test data.

Publications

  • Godefroy V, Tanguy D, Bouzigues A, Sezer I, Ferrand-Verdejo J, Azuar C, Bendetowicz D, Carle G, Rametti-Lacroux A, Bombois S, Cognat E, Jannin P, Morandi X, Ber IL, Levy R, Batrancourt B, Migliaccio R. Frontotemporal dementia subtypes based on behavioral inhibition deficits. Alzheimers Dement (Amst). 2021 Apr 6;13(1):e12178. doi: 10.1002/dad2.12178. eCollection 2021.

    PubMed 33851004

  • 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.

    PubMed 35751676

  • 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.

    PubMed 36155506

  • Godefroy V, Durand A, Simon MC, Weber B, Kable J, Lerman C, Bergstrom F, Levy R, Batrancourt B, Schmidt L, Plassmann H, Koban L. A structural MRI marker predicts individual differences in impulsivity and classifies patients with behavioral-variant frontotemporal dementia from matched controls. bioRxiv [Preprint]. 2024 Sep 16:2024.09.12.612706. doi: 10.1101/2024.09.12.612706.

    PubMed 39345385

  • 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.

    PubMed 31551908

  • Peltier C, Lejeune FX, Jorgensen LGT, Rametti-Lacroux A, Tanguy D, Godefroy V, Bendetowicz D, Carle G, Cognat E, Bombois S, Migliaccio R, Levy R, Marin F, Batrancourt B; ECOCAPTURE study group. A temporal classification method based on behavior time series data in patients with behavioral variant of frontotemporal dementia and apathy. J Neurosci Methods. 2022 Jul 1;376:109625. doi: 10.1016/j.jneumeth.2022.109625. Epub 2022 May 30.

    PubMed 35653896

  • Tanguy D, Batrancourt B, Estudillo-Romero A, Baxter JSH, Le Ber I, Bouzigues A, Godefroy V, Funkiewiez A, Chamayou C, Volle E, Saracino D, Rametti-Lacroux A, Morandi X, Jannin P, Levy R, Migliaccio R; ECOCAPTURE study group. An ecological approach to identify distinct neural correlates of disinhibition in frontotemporal dementia. Neuroimage Clin. 2022;35:103079. doi: 10.1016/j.nicl.2022.103079. Epub 2022 Jun 7.

    PubMed 35700600

  • 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.

    PubMed 36658040

Questions about this trial

What is this clinical trial studying?

A study testing ECOCAPTURE, Cognitive and Behavioral experimental tasks and Neuropsychological assessment in people with Apathy and Behavioral Variant Frontotemporal Dementia (bvFTD), 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 14 inclusion and 3 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 20 May 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?

Frequency of each behavior in the ECOCAPTURE ethogram (time frame: 45 minutes). The study lists 12 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 NCT03272230, which also lists 8 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 20 May 2026.

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