Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies

Epilepsy Clinical Trial

— SPIRALE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04749901
• Other study ID #: 2020-42
• Secondary ID: ID-RCB
• Status: Terminated
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: June 13, 2023

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 129
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Other:
• Psycho-emotional and semiological measures
Surveys, interviews and measures

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

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