Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers (STELLA)

Evaluation of Stress Sensitivity and Hyperemotivity in Temporal Lobe Epilepsy With Enlarged Amygdala Compared to Epilepsy Without Enlarged Amygdala (Temporal and Extra-temporal) and a Group of Healthy Volunteers: Pilot Study.

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.

Study Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Other: Measure of emotional stressors

Detailed Description

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 impact of emotional stress factors for precipitating seizures
• The perception of stress (PSS-10).
• Psychiatric comorbidities (anxiety, depression, post-traumatic stress disorder, emotional lability…).

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).

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie DENUELLE, MD; Phone Number: 33 5 61 77 79 24; Email: denuelle.m@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital Toulouse
    • Contact: Marie DENUELLE, MD; Phone Number: 33 05 61 77 79 24; Email: denuelle.m@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- For all epileptic patients: Age between 18 and 65. Epilepsy (TLE or not) followed by an epileptologist.

- For TLE-AE: An AE identified on the MRI by an expert neuroradiologist. MRI must be less than one year.

- For non AE epileptic patients: No AE reported in the MRI by an expert neuroradiologist.

Exclusion Criteria:

• Any mental disorder.
• Any diabetes
• Beta-blockers
• Neuroleptics
• Any neurologic diseases for the healthy volunteers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TLE-AE Group; 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; 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
Active Comparator: Non AE epileptic Group; 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; 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
Active Comparator: Extra-temporal epilepsy Group; 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; 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
Active Comparator: Healthy volunteers Group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of The Emotional Stroop tasks	The score of the congruency index in the Emotional Stroop tasks : evaluate the attention bias towards threatening information	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	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	30 minutes
Score of The Perceived Stress Scale 10	The score of the Perceived Stress Scale 10 : evaluate the perception of stress	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.	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.	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	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.	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.	30 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Marie DENUELLE, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: PTSD; depression; anxiety; stress; temporal lobe epilepsy; attentional bias; amygdala enlargement
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: RC31/17/0276; 2017-A02853-50 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No