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

NCT04749901 | Terminated

• 2 other identifiers: 2020-42ID-RCB
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (4)

Patients with epilepsy

OTHER

Other: Psycho-emotional and semiological measures

Patients with PTSD

OTHER

Other: Psycho-emotional and semiological measures

Patients with type 1 diabetes

OTHER

Other: Psycho-emotional and semiological measures

Patients with a heart rhythm disorder

OTHER

Other: Psycho-emotional and semiological measures

Interventions

Psycho-emotional and semiological measures OTHER

Surveys, interviews and measures

Also known as: Cognitive measures, Physiological measurements, Qualitative measures

Patients with PTSD; Patients with a heart rhythm disorder; Patients with epilepsy; Patients with type 1 diabetes

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jean-Olivier ARNAUD

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: February 11, 2021
• Study Start: February 11, 2021
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)