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

NCT02976545 | Completed

• 1 other identifier: 2016-A01295-46
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Psychogenic Non-epileptic Seizures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Valence and intensity of the emotional images

  6 months after the last inclusion

• Cerebral functional connectivity

  6 months after the last inclusion

• "Dissociative Experience Scale (DES) questionnaire" score and "Toronto Alexithymia Scale (TAS20) questionnaire" score

  6 months after the last inclusion

Study Arms (3)

PNES

OTHER

Psychogenic Non-epileptic Seizures subjects

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

PTSD

OTHER

Post Traumatic Stress Disorder

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

Healthy controls

OTHER

Healthy controls

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

Interventions

fMRI (functional Magnetic Resonance Imaging) DEVICE

fMRI examination

Healthy controls; PNES; PTSD

psychiatric evaluation BEHAVIORAL

psychiatric evaluation

Healthy controls; PNES; PTSD

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female,
• Right-handed
• Affiliation to the French social security system,
• Informed signing of the study consent.
• PNES diagnosed by a neurologist specialized in epilepsy, based on clinical symptoms analysis and video-EEG recording,
• Absence of concomitant epilepsy.

You may not qualify if:

• 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.).
• Diagnosis of PTSD challenged or denied by the patient, current or history of functional neurological symptom disorder,
• History of PNES (conversion disorder).
• History of PTSD,

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

Location

Related Publications (1)

• 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.

  PMID: 34995332 BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: November 29, 2016
• Study Start: October 3, 2017
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

FR (1)