Clinical trial NCT03464370: Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: amygdala enlargement
temporal lobe epilepsy
stress
attentional bias
anxiety
depression
PTSD
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study is prospective, monocentric, epidemiologic, case control
Primary purpose: OTHER

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Score on the scale of emotional seizure precipitant the outbreak
timeFrame: 30 minutes
Secondary outcomes:
measure: Score of The Emotional Stroop tasks
timeFrame: 30 minutes
measure: Score of The congruency index
timeFrame: 30 minutes
measure: Score of the Scale measures during the movie tasks
timeFrame: 30 minutes
measure: Score of The Perceived Stress Scale 10
timeFrame: 30 minutes
measure: Score of The Tyrer's brief Scale for Anxiety (BAS)
timeFrame: 30 minutes
measure: Score of The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).
timeFrame: 30 minutes
measure: Score of The Affect intensity measure (AIM)
timeFrame: 30 minutes
measure: Score of The Clinical-administered PTSD Scale (CAPS)
timeFrame: 30 minutes
measure: Score of The Post-Traumatic Checklist Scale (PCLS).
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Marie DENUELLE, MD
role: PRINCIPAL_INVESTIGATOR
References: