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Completed

NCT Number: NCT02976545

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

fmri (functional magnetic resonance imaging)

Device

fMRI examination

psychiatric evaluation

Behavioral

psychiatric evaluation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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;

  2. 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

  3. "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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

VECU EMOTIONNEL CHEZ LES PATIENTES SOUFFRANT DE CRISES NON EPILEPTIQUES PSYCHOGENES : ETUDE EN IMAGERIE PAR RESONANCE MAGNETIQUE FONCTIONNELLE-ETUDE EMOCRISES

Acronym: EMOCRISES

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2016
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.