SPIRALE: Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Patients with epilepsy
|
Other: Psycho-emotional and semiological measures
Surveys, interviews and measures
Other Names:
|
| Other: Patients with PTSD
|
Other: Psycho-emotional and semiological measures
Surveys, interviews and measures
Other Names:
|
| Other: Patients with type 1 diabetes
|
Other: Psycho-emotional and semiological measures
Surveys, interviews and measures
Other Names:
|
| Other: Patients with a heart rhythm disorder
|
Other: Psycho-emotional and semiological measures
Surveys, interviews and measures
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Anxiety level [Baseline]
Beck Anxiety inventory (0-63), higher values mean worse outcome
- Depression [Baseline]
Beck Anxiety inventory (0-21), higher values mean worse outcome
- Number of patients with PTSD [Baseline]
Post-traumatic stress disorder
- Emotion regulation [Baseline]
The difficulties in emotion regulation scale,(0-180), higher values mean better outcome
- Quality of life of the patient [Baseline]
Medical Outcome Study and 36-item Short Form Health Survey (0-60),higher values mean worse outcome
- Seizures control [Baseline]
Seizure control scale (0-85), higher values mean better outcome
- Seizures control (heart rythm) [Baseline]
HRSC
- PTSD [Baseline]
PTSD-E (0-100), higher values mean worse outcome
- Emotionnal control of diabete [Baseline]
DID-C (Diabete insulino-dependant-Control) (elaborated for the study) (0-150), higher values mean worse outcome
- Emotionnal control of diabete and PTSD [Baseline]
DID-PTSD (Diabete insulino-dependant-Posttraumatic Stress Disorder) (elaborated for the study) (0-185), higher values mean worse outcome
- Skin conductance [Baseline]
BIOPAC SCL (EDA 100C)
- Eyes movements [Baseline]
EyeLink 1000 (SR Research)
- Heart rythm variability [Baseline]
BIOPAC ECG (EL250)
- Attentional and executive control [Baseline]
Attentional and executive control task in the context of hypervigilance (elaborated for the study) (0-180), higher values mean worse outcome
Eligibility Criteria
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.
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Group of patients with T1 diabetes mellitus [Group D]: definite diagnosis of type 1 diabetes established by a specialist doctor.
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Group of patients with PTSD [Group T]: definite diagnosis of PTSD established by a specialist doctor.
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Person having given his non-objection
Exclusion Criteria:
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Pregnancy;
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Breastfeeding women;
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Severe cognitive impairment
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Addiction to alcohol or drugs (including drugs other than those related to epilepsy or the chronic disease from which the patient has);
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Other neurological and / or psychiatric disorders than CNEP or epilepsy except anxiety and depressive disorders;
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Adults under guardianship or under judicial protection
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People deprived of their liberty
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Inability to read French.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assistance Publique Hopitaux de Marseille | Marseille | France | 13354 |
Sponsors and Collaborators
- Assistance Publique Hopitaux De Marseille
Investigators
- Study Director: Jean-Olivier ARNAUD, Assistance Publique Hôpitaux de Marseille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-42
- ID-RCB