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.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Score on the scale of emotional seizure precipitant the outbreak
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Any mental disorder.
- •Any diabetes
- •Beta-blockers
- •Neuroleptics
- •Any neurologic diseases for the healthy volunteers.
研究组 & 干预措施
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.
干预措施: Measure of emotional stressors (Other)
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.
干预措施: Measure of emotional stressors (Other)
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.
干预措施: Measure of emotional stressors (Other)
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
干预措施: Measure of emotional stressors (Other)
结局指标
主要结局
Score on the scale of emotional seizure precipitant the outbreak
时间窗: 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.
次要结局
- 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)