Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies (SPIRALE)
Primary Purpose
Epilepsy
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psycho-emotional and semiological measures
Sponsored by
About this trial
This is an interventional other trial for Epilepsy
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.
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Patients with epilepsy
Patients with PTSD
Patients with type 1 diabetes
Patients with a heart rhythm disorder
Arm Description
Outcomes
Primary Outcome Measures
Anxiety level
Beck Anxiety inventory (0-63), higher values mean worse outcome
Depression
Beck Anxiety inventory (0-21), higher values mean worse outcome
Number of patients with PTSD
Post-traumatic stress disorder
Emotion regulation
The difficulties in emotion regulation scale,(0-180), higher values mean better outcome
Quality of life of the patient
Medical Outcome Study and 36-item Short Form Health Survey (0-60),higher values mean worse outcome
Seizures control
Seizure control scale (0-85), higher values mean better outcome
Seizures control (heart rythm)
HRSC
PTSD
PTSD-E (0-100), higher values mean worse outcome
Emotionnal control of diabete
DID-C (Diabete insulino-dependant-Control) (elaborated for the study) (0-150), higher values mean worse outcome
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
Skin conductance
BIOPAC SCL (EDA 100C)
Eyes movements
EyeLink 1000 (SR Research)
Heart rythm variability
BIOPAC ECG (EL250)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04749901
First Posted
January 14, 2021
Last Updated
July 22, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04749901
Brief Title
Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies
Acronym
SPIRALE
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Impossible to pursue the study
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
June 13, 2023 (Actual)
Study Completion Date
June 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with epilepsy
Arm Type
Other
Arm Title
Patients with PTSD
Arm Type
Other
Arm Title
Patients with type 1 diabetes
Arm Type
Other
Arm Title
Patients with a heart rhythm disorder
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Psycho-emotional and semiological measures
Other Intervention Name(s)
Cognitive measures, Physiological measurements, Qualitative measures
Intervention Description
Surveys, interviews and measures
Primary Outcome Measure Information:
Title
Anxiety level
Description
Beck Anxiety inventory (0-63), higher values mean worse outcome
Time Frame
Baseline
Title
Depression
Description
Beck Anxiety inventory (0-21), higher values mean worse outcome
Time Frame
Baseline
Title
Number of patients with PTSD
Description
Post-traumatic stress disorder
Time Frame
Baseline
Title
Emotion regulation
Description
The difficulties in emotion regulation scale,(0-180), higher values mean better outcome
Time Frame
Baseline
Title
Quality of life of the patient
Description
Medical Outcome Study and 36-item Short Form Health Survey (0-60),higher values mean worse outcome
Time Frame
Baseline
Title
Seizures control
Description
Seizure control scale (0-85), higher values mean better outcome
Time Frame
Baseline
Title
Seizures control (heart rythm)
Description
HRSC
Time Frame
Baseline
Title
PTSD
Description
PTSD-E (0-100), higher values mean worse outcome
Time Frame
Baseline
Title
Emotionnal control of diabete
Description
DID-C (Diabete insulino-dependant-Control) (elaborated for the study) (0-150), higher values mean worse outcome
Time Frame
Baseline
Title
Emotionnal control of diabete and PTSD
Description
DID-PTSD (Diabete insulino-dependant-Posttraumatic Stress Disorder) (elaborated for the study) (0-185), higher values mean worse outcome
Time Frame
Baseline
Title
Skin conductance
Description
BIOPAC SCL (EDA 100C)
Time Frame
Baseline
Title
Eyes movements
Description
EyeLink 1000 (SR Research)
Time Frame
Baseline
Title
Heart rythm variability
Description
BIOPAC ECG (EL250)
Time Frame
Baseline
Title
Attentional and executive control
Description
Attentional and executive control task in the context of hypervigilance (elaborated for the study) (0-180), higher values mean worse outcome
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies
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