Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies: Incidence and Influence on Cognitive Control Capacities and on Seizure Control
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Emotion regulation
研究概览
简要总结
Epilepsy is a neurological disease that can cause many comorbid psychiatric disorders, among them: generalized anxiety disorder and depression. Many studies suggest a temporal relationship between exposure to a traumatic event and the development of epilepsy. The objective of this research is to study the symptoms of post-traumatic stress disorder (PTS) in patients with epilepsy, and their relation to anxiety and depression in these patients. The investigators also wish to study how such symptoms may be associated with the subjective semiological manifestations of epileptic seizures. In addition, it has been shown that patients with epilepsy are able, from the identification of different warning signs, to anticipate their vulnerability to having an epileptic seizure allowing them to set up different types. strategies to control them. The investigators also wish to study the cognitive processes involved in this control and the influence of PTS symptoms, in particular hypervigilance on this behavior.
The investigators propose a protocol using different types of measures: emotional, cognitive and physiological in order to answer our questions. In addition to patients with epilepsy, two groups of patients will be included: a group of patients with another chronic non-neurological disease to compare the prevalence of PTS symptoms and a group of patients with post-traumatic stress disorder ( PTSD) to compare with patients with epilepsy, cognitive and physiological measures.
Finally, the results of this study should allow to develop tools for assessing PTS symptoms in epilepsy and to develop specific management approaches
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman between 18 and 50 years old;
- •Native French speaker;
- •Level of education higher than the 3rd school level;
- •Certain diagnosis of the pathology of the experimental group with which he will be associated, more precisely:
- •Group of patients with epilepsy [Group E]: definite diagnosis of drug-resistant epilepsy (epileptic seizures persist despite the administration of daily treatment) established by a specialist physician.
- •Group of patients with a heart rhythm disorder [Group C]: definite diagnosis of one of the following disorders: Atrial Fibrillation (AF); Syncope and Bouveret's disease established by a specialist.
- •Group of patients with T1 diabetes mellitus [Group D]: definite diagnosis of type 1 diabetes established by a specialist doctor.
- •Group of patients with PTSD [Group T]: definite diagnosis of PTSD established by a specialist doctor.
- •Person having given his non-objection
排除标准
- •Pregnancy;
- •Breastfeeding women;
- •Severe cognitive impairment
- •Addiction to alcohol or drugs (including drugs other than those related to epilepsy or the chronic disease from which the patient has);
- •Other neurological and / or psychiatric disorders than CNEP or epilepsy except anxiety and depressive disorders;
- •Adults under guardianship or under judicial protection
- •People deprived of their liberty
- •Inability to read French.
结局指标
主要结局
Emotion regulation
时间窗: Baseline
The difficulties in emotion regulation scale,(0-180), higher values mean better outcome
Anxiety level
时间窗: Baseline
Beck Anxiety inventory (0-63), higher values mean worse outcome
Seizures control
时间窗: Baseline
Seizure control scale (0-85), higher values mean better outcome
Number of patients with PTSD
时间窗: Baseline
Post-traumatic stress disorder
Skin conductance
时间窗: Baseline
BIOPAC SCL (EDA 100C)
Depression
时间窗: Baseline
Beck Anxiety inventory (0-21), higher values mean worse outcome
Quality of life of the patient
时间窗: Baseline
Medical Outcome Study and 36-item Short Form Health Survey (0-60),higher values mean worse outcome
Emotionnal control of diabete and PTSD
时间窗: Baseline
DID-PTSD (Diabete insulino-dependant-Posttraumatic Stress Disorder) (elaborated for the study) (0-185), higher values mean worse outcome
Eyes movements
时间窗: Baseline
EyeLink 1000 (SR Research)
Seizures control (heart rythm)
时间窗: Baseline
HRSC
PTSD
时间窗: Baseline
PTSD-E (0-100), higher values mean worse outcome
Emotionnal control of diabete
时间窗: Baseline
DID-C (Diabete insulino-dependant-Control) (elaborated for the study) (0-150), higher values mean worse outcome
Attentional and executive control
时间窗: Baseline
Attentional and executive control task in the context of hypervigilance (elaborated for the study) (0-180), higher values mean worse outcome
Heart rythm variability
时间窗: Baseline
BIOPAC ECG (EL250)
次要结局
未报告次要终点