Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies (SPIRALE)

Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies: Incidence and Influence on Cognitive Control Capacities and on Seizure Control

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

Study Overview

• Status: Terminated
• Conditions: Epilepsy
• Intervention / Treatment: Other: Psycho-emotional and semiological measures

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with epilepsy	Other: Psycho-emotional and semiological measures; Surveys, interviews and measures; Other Names: Cognitive measures; Physiological measurements; Qualitative measures
Other: Patients with PTSD	Other: Psycho-emotional and semiological measures; Surveys, interviews and measures; Other Names: Cognitive measures; Physiological measurements; Qualitative measures
Other: Patients with type 1 diabetes	Other: Psycho-emotional and semiological measures; Surveys, interviews and measures; Other Names: Cognitive measures; Physiological measurements; Qualitative measures
Other: Patients with a heart rhythm disorder	Other: Psycho-emotional and semiological measures; Surveys, interviews and measures; Other Names: Cognitive measures; Physiological measurements; Qualitative measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level	Beck Anxiety inventory (0-63), higher values mean worse outcome	Baseline
Depression	Beck Anxiety inventory (0-21), higher values mean worse outcome	Baseline
Number of patients with PTSD	Post-traumatic stress disorder	Baseline
Emotion regulation	The difficulties in emotion regulation scale,(0-180), higher values mean better outcome	Baseline
Quality of life of the patient	Medical Outcome Study and 36-item Short Form Health Survey (0-60),higher values mean worse outcome	Baseline
Seizures control	Seizure control scale (0-85), higher values mean better outcome	Baseline
Seizures control (heart rythm)	HRSC	Baseline
PTSD	PTSD-E (0-100), higher values mean worse outcome	Baseline
Emotionnal control of diabete	DID-C (Diabete insulino-dependant-Control) (elaborated for the study) (0-150), higher values mean worse outcome	Baseline
Emotionnal control of diabete and PTSD	DID-PTSD (Diabete insulino-dependant-Posttraumatic Stress Disorder) (elaborated for the study) (0-185), higher values mean worse outcome	Baseline
Skin conductance	BIOPAC SCL (EDA 100C)	Baseline
Eyes movements	EyeLink 1000 (SR Research)	Baseline
Heart rythm variability	BIOPAC ECG (EL250)	Baseline
Attentional and executive control	Attentional and executive control task in the context of hypervigilance (elaborated for the study) (0-180), higher values mean worse outcome	Baseline

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Jean-Olivier ARNAUD, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 2020-42; ID-RCB (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No