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Clinical Trials/NCT03464370
NCT03464370
Unknown
Not Applicable

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.

University Hospital, Toulouse1 site in 1 country120 target enrollmentMarch 8, 2018
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
University Hospital, Toulouse
Enrollment
120
Locations
1
Primary Endpoint
Score on the scale of emotional seizure precipitant the outbreak
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 8, 2018
End Date
March 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For all epileptic patients: Age between 18 and
  • 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.

Outcomes

Primary Outcomes

Score on the scale of emotional seizure precipitant the outbreak

Time Frame: 30 minutes

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.

Secondary Outcomes

  • Score of The Emotional Stroop tasks(30 minutes)
  • Score of The congruency index(30 minutes)
  • Score of the Scale measures during the movie tasks(30 minutes)
  • Score of The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).(30 minutes)
  • Score of The Clinical-administered PTSD Scale (CAPS)(30 minutes)
  • Score of The Post-Traumatic Checklist Scale (PCLS).(30 minutes)
  • Score of The Perceived Stress Scale 10(30 minutes)
  • Score of The Tyrer's brief Scale for Anxiety (BAS)(30 minutes)
  • Score of The Affect intensity measure (AIM)(30 minutes)

Study Sites (1)

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