- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03243370
Clock'N' Test: Development and Validation of a Test to Evaluate Emotional Disorders (Clock'N'test)
Clock'N' Test: Development and Validation (in a Control Population) of a Test Based on Time Estimations and Aiming to Evaluate Emotional Disorders
This study concerns the validation of a clinical test that aims to reveal "first level" emotional disorders in neurological diseases.
In order to bring to light such disorders, it is necessary to begin by establishing reference values in healthy individuals. This test is based on the priming effect and time estimations. The test procedure has two successive phases. The first phase aims to determine the judgement of time inherent to each participant and then to assess whether or not this judgement varies during the second phase with the introduction of emotional priming. First, we set out to look for and to calibrate video stimuli able to activate emotions. To this end, we used a battery of 70 sequences developed recently by Schaefer, Nils, Sanchez and Philippot. We determined their degree of physiological activation by measuring the electrodermal response at the laboratory for the exploration of the nervous system in Dijon. These measurements also allowed us to define and refine our paradigm, notably by deciding at what moment the time estimation task should be done and by eliminating the influence of attention. We decided to select only seven video sequences because we noticed a reduction in the measurement effect on time estimations due to habituation of the subject. We also conducted pre-tests in a control population made up of twenty men and women aged from 20 to 60 years.
This brought to light a warp in time estimation opposite to that we found using olfactory stimuli. This first finding suggests that there are two types of emotion, one which is anticipative and the other immediately experienced.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dijon, France, 21079
- CHU de Dijon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- persons who have given their consent to participate
- aged between 20 and 92 years.
- persons who understand and speak French.
- persons informed about the study
Exclusion Criteria:
- persons without national health insurance cover
- disease likely to cause emotional disorders (history of paralimbic brain tumour, MS, Parkinson, history of depression, bipolar disorder…).
- heart disease, spasmophilia.
- cognitive disorders likely to interfere with understanding the instructions.
- visual or auditory, sensory or motor disorders.
- refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score obtained in the Clock n'test: [time estimation with priming]-[time estimation without priming].
Time Frame: 1 day
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Bring to light "first-level" emotional disorders.
It is based on the priming effect of time estimation
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1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GROS-GIROUD-2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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