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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

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

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

NCT ID

NCT02976545

First Posted

November 25, 2016

Last Updated

June 10, 2021

Sponsor

Central Hospital, Nancy, France

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

c.hingray@chru-nancy.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Gabriela Hossu, PhD

Phone

33383155096

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

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