Clinical trial NCT04749901: Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies
Official title: Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies: Incidence and Influence on Cognitive Control Capacities and on Seizure Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epilepsy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Anxiety level
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Number of patients with PTSD
timeFrame: Baseline
measure: Emotion regulation
timeFrame: Baseline
measure: Quality of life of the patient
timeFrame: Baseline
measure: Seizures control
timeFrame: Baseline
measure: Seizures control (heart rythm)
timeFrame: Baseline
measure: PTSD
timeFrame: Baseline
measure: Emotionnal control of diabete
timeFrame: Baseline
measure: Emotionnal control of diabete and PTSD
timeFrame: Baseline
measure: Skin conductance
timeFrame: Baseline
measure: Eyes movements
timeFrame: Baseline
measure: Heart rythm variability
timeFrame: Baseline
measure: Attentional and executive control
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD
role: STUDY_DIRECTOR
References: