Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT03464370 Statut inconnu

Titre

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. (STELLA)

Type

Interventional

Pathologie

Épilepsie

Phase

N/A

Promoteur

University Hospital, Toulouse (Voir sur ClinicalTrials)

Date de début

mars 2018

Date de fin

mars 2020

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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). Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
University Hospital Toulouse - 31059 - Toulouse - France	Marie DENUELLE, MD	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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.

Critère de non inclusion

- Any mental disorder.

- Any diabetes

- Beta-blockers

- Neuroleptics

- Any neurologic diseases for the healthy volunteers.

NCT03464370 - 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. (STELLA)

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