Psychogenic Non-epileptic Seizures Clinical Trial
— EMOCRISESOfficial title:
VECU EMOTIONNEL CHEZ LES PATIENTES SOUFFRANT DE CRISES NON EPILEPTIQUES PSYCHOGENES : ETUDE EN IMAGERIE PAR RESONANCE MAGNETIQUE FONCTIONNELLE-ETUDE EMOCRISES
| Verified date | March 2024 |
| Source | Central Hospital, Nancy, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | September 30, 2022 |
| Est. primary completion date | September 30, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU de Nancy | Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
Fauve P, Tyvaert L, Husson C, Hologne E, Gao X, Maillard L, Schwan R, Banasiak C, El-Hage W, Hossu G, Hingray C. Functional MRI-based study of emotional experience in patients with psychogenic non-epileptic seizures: Protocol for an observational case-control study-EMOCRISES study. PLoS One. 2022 Jan 7;17(1):e0262216. doi: 10.1371/journal.pone.0262216. eCollection 2022. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brain activity | 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 | Valence and intensity of the emotional images | To compare subjective experience rating across the three groups, during emotional pictures watching task; | 6 months after the last inclusion | |
| Secondary | Cerebral functional connectivity | 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 | |
| Secondary | "Dissociative Experience Scale (DES) questionnaire" score and "Toronto Alexithymia Scale (TAS20) questionnaire" score | 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 |