Emotional Lived in Patients Suffering From Psychogenic Nonepileptic Seizures : Study by Functional Magnetic Resonance Imaging

Not Applicable

Completed

• Conditions: Psychogenic Non-epileptic Seizures
• Interventions: Device: fMRI (functional Magnetic Resonance Imaging); Behavioral: psychiatric evaluation

• Registration Number: NCT02976545
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Study Start: 2017-10-03
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTSD	psychiatric evaluation	Post Traumatic Stress Disorder
Healthy controls	fMRI (functional Magnetic Resonance Imaging)	Healthy controls
Healthy controls	psychiatric evaluation	Healthy controls
PTSD	fMRI (functional Magnetic Resonance Imaging)	Post Traumatic Stress Disorder
PNES	psychiatric evaluation	Psychogenic Non-epileptic Seizures subjects
PNES	fMRI (functional Magnetic Resonance Imaging)	Psychogenic Non-epileptic Seizures subjects

Primary Outcome Measures

Name	Time	Method
Brain activity	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.

Secondary Outcome Measures

Name	Time	Method
"Dissociative Experience Scale (DES) questionnaire" score and "Toronto Alexithymia Scale (TAS20) questionnaire" score	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
Valence and intensity of the emotional images	6 months after the last inclusion	To compare subjective experience rating across the three groups, during emotional pictures watching task;
Cerebral functional connectivity	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

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Nancy, France