search
Back to results

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

Primary Purpose

Psychogenic Non-epileptic Seizures

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI (functional Magnetic Resonance Imaging)
psychiatric evaluation
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psychogenic Non-epileptic Seizures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

PNES

PTSD

Healthy controls

Arm Description

Psychogenic Non-epileptic Seizures subjects

Post Traumatic Stress Disorder

Healthy controls

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Valence and intensity of the emotional images
To compare subjective experience rating across the three groups, during emotional pictures watching task;
Cerebral functional connectivity
To compare differences of cerebral functional connectivity (main physiological brain networks) in resting state fMRI across the tree groups
"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

Full Information

First Posted
November 25, 2016
Last Updated
June 10, 2021
Sponsor
Central Hospital, Nancy, France
search

1. Study Identification

Unique Protocol Identification Number
NCT02976545
Brief Title
Emotional Lived in Patients Suffering From Psychogenic Nonepileptic Seizures : Study by Functional Magnetic Resonance Imaging
Acronym
EMOCRISES
Official Title
VECU EMOTIONNEL CHEZ LES PATIENTES SOUFFRANT DE CRISES NON EPILEPTIQUES PSYCHOGENES : ETUDE EN IMAGERIE PAR RESONANCE MAGNETIQUE FONCTIONNELLE-ETUDE EMOCRISES
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychogenic Non-epileptic Seizures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PNES
Arm Type
Other
Arm Description
Psychogenic Non-epileptic Seizures subjects
Arm Title
PTSD
Arm Type
Other
Arm Description
Post Traumatic Stress Disorder
Arm Title
Healthy controls
Arm Type
Other
Arm Description
Healthy controls
Intervention Type
Device
Intervention Name(s)
fMRI (functional Magnetic Resonance Imaging)
Intervention Description
fMRI examination
Intervention Type
Behavioral
Intervention Name(s)
psychiatric evaluation
Intervention Description
psychiatric evaluation
Primary Outcome Measure Information:
Title
Brain activity
Description
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.
Time Frame
6 months after the last inclusion
Secondary Outcome Measure Information:
Title
Valence and intensity of the emotional images
Description
To compare subjective experience rating across the three groups, during emotional pictures watching task;
Time Frame
6 months after the last inclusion
Title
Cerebral functional connectivity
Description
To compare differences of cerebral functional connectivity (main physiological brain networks) in resting state fMRI across the tree groups
Time Frame
6 months after the last inclusion
Title
"Dissociative Experience Scale (DES) questionnaire" score and "Toronto Alexithymia Scale (TAS20) questionnaire" score
Description
To study the correlation between cerebral activity and level of dissociation (DES) and alexithymia (TAS20) in PNES and PTSD groups
Time Frame
6 months after the last inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Coraline Hingray, MD
Phone
33383926260
Email
c.hingray@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela Hossu, PhD
Phone
33383155096
Email
g.hossu@chru-nancy.fr
Facility Information:
Facility Name
CHRU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coraline Hingray, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs