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

March 13, 2024 updated by: M.D. Coraline HINGRAY, Central Hospital, Nancy, France

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

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Nancy, France, 54000
        • CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimated)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-A01295-46

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Psychogenic Non-epileptic Seizures

Clinical Trials on fMRI (functional Magnetic Resonance Imaging)

3
Subscribe