An interventional study of Measure of emotional stressors in Epilepsy, sponsored by University Hospital, Toulouse. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other
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Recently, a possible subtype of temporal lobe epilepsy (TLE) has been proposed: this subtype presents ipsilateral amygdala enlargement (AE) without any other lesion. However, little is known about its clinical and psychiatric phenotype. The amygdala seems to play a major role in stress related disorders (including perception of stress). The hypothesis in this study is that patients with TLE-AE more frequently report emotional distress as a seizure-precipitating factor than any other epileptic patient.
TLE-AE could concern 16 to 64 % of the TLE with "negative" MRI (Beh et al., 2016).
TLE-AE patients may suffer from anxiety and depression (Lv et al, 2014). In clinical practice, it has been also identified an emotional vulnerability in these patients, as they report more frequently a high sensitivity to emotional distress than other epileptic patients. They also report a change in their affect intensity or a hyperemotivity, which appeared at the onset of their epilepsy. Lanteaume et al. have linked some TLE with an increased emotional vulnerability (Emo-TLE): these TLE patients reported stress factors precipitating their seizures. They found that the Emo-TLE group was characterized by an attentional bias toward threatening stimuli versus neutral stimuli, and that this bias was noticed neither in the TLE group without emotional vulnerability nor in healthy volunteers. But they did not study amygdala structure in each group.In the large database of the Toulouse University Hospital, screening was done to retrospectively collect TLE patients with AE identified on MRI. This large database has served to establish a reading grid in order to help the visual identification of an AE.The investigators propose to these patients them a series of validated scales to test:
The study also propose cognitive tasks to search for an attentional bias towards threatening stimuli (Emotional Stroop and modified probe test). After this, the study will assess their emotional subjective responses (valence, arousal, avoidance) through a task during which they are presented with short movies that elicit six different emotions. At the same time, the measure of the variations of their neurovegetative system in terms of blood pressure, heart rate variability and electrodermal skin conductance variability will be done.
For each TLE-AE patient, additional healthy controls will be matched (2 for testing the primary outcome, 3 for the secondary outcomes).
65 studies on the registry are indexed under Epilepsy, Temporal Lobe; 25 are open to participants now.
This study's planned enrollment of 120 is above the median of 30 across 41 interventional studies indexed under Epilepsy, Temporal Lobe.
Browse Epilepsy, Temporal Lobe studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
Compared within Epilepsy, Temporal Lobe, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epilepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
30 subjects Age between 18 and 65 case-control with 2 witnesses per sex and age matched cases (within 5 years) for the evaluation of the primary endpoint. For the secondary endpoints, 3 controls will be matched for each case on gender and age (within 5 years) Measure of emotional stressors then evaluate the traumatic events and to date them with respect to the beginning of epilepsy in different populations of epileptics.
Other: Measure of emotional stressors
30 subjects Age between 18 and 65 case-control with 2 witnesses per sex and age matched cases (within 5 years) for the evaluation of the primary endpoint. For the secondary endpoints, 3 controls will be matched for each case on gender and age (within 5 years) Measure of emotional stressors then evaluate the traumatic events and to date them with respect to the beginning of epilepsy in different populations of epileptics.
Other: Measure of emotional stressors
30 subjects Age between 18 and 65 case-control with 2 witnesses per sex and age matched cases (within 5 years) for the evaluation of the primary endpoint. For the secondary endpoints, 3 controls will be matched for each case on gender and age (within 5 years) Measure of emotional stressors and then evaluate the traumatic events and to date them with respect to the beginning of epilepsy in different populations of epileptics.
Other: Measure of emotional stressors
30 subjects Age between 18 and 65 case-control with 2 witnesses per sex and age matched cases (within 5 years) for the evaluation of the primary endpoint. For the secondary endpoints, 3 controls will be matched for each case on gender and age (within 5 years) Measure of emotional stressors
Other: Measure of emotional stressors
For the Epileptic Group * Rapid interrogation, completing the clinical data * A scale of impact of the precipitating factors of crises * An emotional Stroop * A task of detecting emotional targets against threatening information * A measure of the perception of emotions using film clips * A scale of measurement of perceived stress * The transfer of psychiatric scales For the healthy volunteers group : * A rapid interrogation, gathering the possible medical history, the level of studies, the manual laterality * An emotional Stroop * A task of detecting emotional targets against threatening information * A scale of measurement of perceived stress * A measure of the perception of emotions using film clips * A rapid neuropsychological assessment
Score on the scale of emotional seizure precipitant the outbreak
It is a hetero-questionnaire, subjectively measuring the sensitivity of an epileptic patient to the stressors of daily life that may trigger or promote the onset of their seizures.
Time frame: 30 minutes
Score of The Emotional Stroop tasks
The score of the congruency index in the Emotional Stroop tasks : evaluate the attention bias towards threatening information
Time frame: 30 minutes
Score of The congruency index
The score of the congruency index in the modified probe detection tasks : evaluate the attention bias towards threatening information
Time frame: 30 minutes
Score of the Scale measures during the movie tasks
The score of scale (valence, arousal, avoidance) in the movie tasks : evaluate the emotional experience using film clips inducing emotion
Time frame: 30 minutes
Score of The Perceived Stress Scale 10
The score of the Perceived Stress Scale 10 : evaluate the perception of stress
Time frame: 30 minutes
Score of The Tyrer's brief Scale for Anxiety (BAS)
The score of the Tyrer's brief Scale for Anxiety (BAS) will evaluate the existence of an anxiety syndrome.This scale is validated, it is a hetero-questionnaire to evaluate anxiety, in 10 items, sides from 0 to 6.
Time frame: 30 minutes
Score of The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).
The score of the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) : the existence of a depressive syndrome.
Time frame: 30 minutes
Score of The Affect intensity measure (AIM)
The score of the Affect intensity measure (AIM) : the multidimensional assessment of thymic states (MAThyS) : evaluate the emotional lability
Time frame: 30 minutes
Score of The Clinical-administered PTSD Scale (CAPS)
The clinical post-traumatic stress disorder scale (CAPS: Clinical-administered PTSD Scale) is the gold standard for diagnosing Post-Traumatic Stress Disorder (PTSD). To pass the entire questionnaire, it takes about sixty minutes. For the scoring list of milestones, it takes about 5 minutes. The CAPS is the only questionnaire that provides information on both the frequency and intensity of symptoms, with specific behavioral anchor points.
Time frame: 30 minutes
Score of The Post-Traumatic Checklist Scale (PCLS).
The Post-Traumatic Checklist Scale (PCLS) is a simple self-questionnaire of about 10 minutes measuring the three main sub-syndromes of post-traumatic stress disorder: repetition (items 1 to 5), avoidance ( items 6 to 12) and neurovegetative hyperactivity (items 13 to 17). The scale is composed of 17 items, rated from 1 to 5. There is a cut-off at ≥ 45 to diagnose post-traumatic stress disorder. The validity of the French translation has been verified.
Time frame: 30 minutes
Plan to share: No
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Started Mar 2018 (actual). Primary completion is estimated for Mar 2020, 24 months after the start.
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This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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