- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02976545
Emotional Lived in Patients Suffering From Psychogenic Nonepileptic Seizures : Study by Functional Magnetic Resonance Imaging (EMOCRISES)
VECU EMOTIONNEL CHEZ LES PATIENTES SOUFFRANT DE CRISES NON EPILEPTIQUES PSYCHOGENES : ETUDE EN IMAGERIE PAR RESONANCE MAGNETIQUE FONCTIONNELLE-ETUDE EMOCRISES
Currently, hypothetical models of understanding Psychogenic Non-epileptic Seizures (PNES) involve emotional dysregulation.
The hypothesis of a disorder of emotional experience is mainly based on behavioral data and disturbance of autonomic responses in response to images in emotional content (Mignot et al 2015, in submission; Bakvis et al 2013). Various imaging studies have identified brain structures belonging to the limbic system in particular that seem functionally impaired in this population. These functional connectivity abnormalities are correlated with dissociation scores in PNES patients (Van der Kruijs et al 2012 and 2014).
Investigators propose to specifically study the brain activity of PNES patients during tasks emotional content to identify the mechanisms involved in this emotional dysregulation. This work is essential to understanding the mechanisms and the development of new therapeutic strategies
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Coraline Hingray, MD
- Phone Number: 33383926260
- Email: c.hingray@chru-nancy.fr
Study Locations
-
-
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Nancy, France, 54000
- CHRU de Nancy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Common Inclusion Criteria:
- Female,
- Right-handed
- Affiliation to the French social security system,
- Informed signing of the study consent.
Specific Inclusion Criteria for PNES group :
- PNES diagnosed by a neurologist specialized in epilepsy, based on clinical symptoms analysis and video-EEG recording,
- Absence of concomitant epilepsy.
Specific Inclusion Criteria for PTSD group : PTSD diagnosed by a psychiatrist, based on clinical symptoms as recorded in DSM5 (Diagnostic and Statistical Manual of Mental Disorders).
Specific Inclusion Criteria for healthy controls : Healthy controls will be paired up with patients on age and level of schooling criteria.
Exclusion Criteria:
common criteria for all groups:
- Neurological history or comorbidity (epilepsy included),
- Current neurological treatment,
- Posology change or introduction of psychoactive treatment dating back to less than a month,
- Psychotic comorbidity (schizophrenia),
- Addiction history apart for smoking,
- History of head trauma,
- Mental retardation,
- Being the subject of articles L.1121-5 to L.1121-8 and L1122-1-2 of the French Code of Public Health (i.e. being a not responsible adult),
- Lack of French language proficiency or inability to understand instructions,
- Uncorrected visual impairment,
- Any contraindication to MRI (pacemaker, ferromagnetic foreign body, claustrophobia, etc.).
Specific exclusion Criteria for PNES group : Diagnosis of PNES challenged or denied by the patient.
Specific exclusion Criteria for PTSD group :
- Diagnosis of PTSD challenged or denied by the patient, current or history of functional neurological symptom disorder,
- History of PNES (conversion disorder).
Specific exclusion Criteria for healthy controls :
- History of PTSD,
- History of PNES (conversion disorder).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PNES
Psychogenic Non-epileptic Seizures subjects
|
fMRI examination
psychiatric evaluation
|
Other: PTSD
Post Traumatic Stress Disorder
|
fMRI examination
psychiatric evaluation
|
Other: Healthy controls
|
fMRI examination
psychiatric evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activity
Time Frame: 6 months after the last inclusion
|
To compare brain activity during emotional tasks in fMRI (Blood-Oxygen-Level-Dependent contrast sequences) between: patients suffering from PNES, patients suffering from PTSD and healthy controls, with age and education level matching.
|
6 months after the last inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Valence and intensity of the emotional images
Time Frame: 6 months after the last inclusion
|
To compare subjective experience rating across the three groups, during emotional pictures watching task;
|
6 months after the last inclusion
|
Cerebral functional connectivity
Time Frame: 6 months after the last inclusion
|
To compare differences of cerebral functional connectivity (main physiological brain networks) in resting state fMRI across the tree groups
|
6 months after the last inclusion
|
"Dissociative Experience Scale (DES) questionnaire" score and "Toronto Alexithymia Scale (TAS20) questionnaire" score
Time Frame: 6 months after the last inclusion
|
To study the correlation between cerebral activity and level of dissociation (DES) and alexithymia (TAS20) in PNES and PTSD groups
|
6 months after the last inclusion
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-A01295-46
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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