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

Central Hospital, Nancy, France

Status: Completed

Conditions: Psychogenic Non-epileptic Seizures

Treatments: Device: fMRI (functional Magnetic Resonance Imaging); Behavioral: psychiatric evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT02976545

2016-A01295-46

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

PNES

Other group

Description:

Psychogenic Non-epileptic Seizures subjects

Treatment:

Device: fMRI (functional Magnetic Resonance Imaging)

Behavioral: psychiatric evaluation

PTSD

Other group

Description:

Post Traumatic Stress Disorder

Treatment:

Device: fMRI (functional Magnetic Resonance Imaging)

Behavioral: psychiatric evaluation

Healthy controls

Other group

Description:

Healthy controls

Treatment:

Device: fMRI (functional Magnetic Resonance Imaging)

Behavioral: psychiatric evaluation