CompletedNot Applicable

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

France68 participantsStarted 2017-10-03

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain activity

Timeframe: 6 months after the last inclusion

Trial details

NCT IDNCT02976545

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Psychogenic Non-epileptic Seizures trials