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

Toulouse University Hospital

Status: Unknown

Conditions: Epilepsy

Treatments: Other: Measure of emotional stressors

Study type: Interventional

Funder types: Other

Identifiers

NCT03464370

RC31/17/0276

2017-A02853-50 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

TLE-AE Group

Experimental group

Description:

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.

Treatment:

Other: Measure of emotional stressors

Non AE epileptic Group

Active Comparator group

Description:

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.

Treatment:

Other: Measure of emotional stressors

Extra-temporal epilepsy Group

Active Comparator group

Description:

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.

Treatment:

Other: Measure of emotional stressors

Healthy volunteers Group

Active Comparator group

Description:

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

Treatment:

Other: Measure of emotional stressors