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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03243370
Other study ID # GROS-GIROUD-2014
Secondary ID
Status Completed
Phase N/A
First received February 2, 2017
Last updated August 4, 2017
Start date April 2014
Est. completion date June 2015

Study information

Verified date January 2017
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 92 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Chu de Dijon Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score obtained in the Clock n'test: [time estimation with priming]-[time estimation without priming]. Bring to light "first-level" emotional disorders. It is based on the priming effect of time estimation 1 day
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