Psychogenic Non-epileptic SeizuresEMOCRISESNCT02976545
Emotional Lived in Patients Suffering From Psychogenic Nonepileptic Seizures : Study by Functional Magnetic Resonance Imaging
A study testing fMRI (functional Magnetic Resonance Imaging) and psychiatric evaluation in people with Psychogenic Non-epileptic Seizures, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychogenic Non-epileptic Seizures
- What is being tested?
- fMRI (functional Magnetic Resonance Imaging) and psychiatric evaluation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2017to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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,
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Psychogenic Non-epileptic Seizures
- Being tested
- fMRI (functional Magnetic Resonance Imaging), psychiatric evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI (functional Magnetic Resonance Imaging)Device
fMRI examination
psychiatric evaluationBehavioural
psychiatric evaluation
| Study group | Role | What they receive |
|---|---|---|
| PNES | Other | Psychogenic Non-epileptic Seizures subjects Receives: Device: fMRI (functional Magnetic Resonance Imaging); Behavioral: psychiatric evaluation |
| PTSD | Other | Post Traumatic Stress Disorder Receives: Device: fMRI (functional Magnetic Resonance Imaging); Behavioral: psychiatric evaluation |
| Healthy controls | Other | Healthy controls Receives: Device: fMRI (functional Magnetic Resonance Imaging); Behavioral: psychiatric evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the last inclusion
Secondary outcomes (3)
Valence and intensity of the emotional images
To compare subjective experience rating across the three groups, during emotional pictures watching task;
Measured: 6 months after the last inclusion
Cerebral functional connectivity
To compare differences of cerebral functional connectivity (main physiological brain networks) in resting state fMRI across the tree groups
Measured: 6 months after the last inclusion
"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
Measured: 6 months after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start3 Oct 2017
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychogenic Non-epileptic SeizuresStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.D. Coraline HINGRAY, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976545
- Sponsor's protocol ID
- 2016-A01295-46
- Acronym
- EMOCRISES
- Status last verified
- Mar 2024
- First submitted
- 25 Nov 2016
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fauve P, Tyvaert L, Husson C, Hologne E, Gao X, Maillard L, Schwan R, Banasiak C, El-Hage W, Hossu G, Hingray C. Functional MRI-based study of emotional experience in patients with psychogenic non-epileptic seizures: Protocol for an observational case-control study-EMOCRISES study. PLoS One. 2022 Jan 7;17(1):e0262216. doi: 10.1371/journal.pone.0262216. eCollection 2022.
PubMed 34995332
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VECU EMOTIONNEL CHEZ LES PATIENTES SOUFFRANT DE CRISES NON EPILEPTIQUES PSYCHOGENES : ETUDE EN IMAGERIE PAR RESONANCE MAGNETIQUE FONCTIONNELLE-ETUDE EMOCRISES
- ClinicalTrials.gov ID
- NCT02976545
- Acronym / sponsor ID
- EMOCRISES / 2016-A01295-46
- Conditions
- Psychogenic Non-epileptic Seizures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PNES | Other | Device: fMRI (functional Magnetic Resonance Imaging), Behavioral: psychiatric evaluationPsychogenic Non-epileptic Seizures subjects |
| PTSD | Other | Device: fMRI (functional Magnetic Resonance Imaging), Behavioral: psychiatric evaluationPost Traumatic Stress Disorder |
| Healthy controls | Other | Device: fMRI (functional Magnetic Resonance Imaging), Behavioral: psychiatric evaluationHealthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI (functional Magnetic Resonance Imaging)fMRI examination | Device | Healthy controls, PNES, PTSD |
| psychiatric evaluationpsychiatric evaluation | Behavioural | Healthy controls, PNES, PTSD |
Primary outcome
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.
3 secondary outcomes
Valence and intensity of the emotional images
Time frame: 6 months after the last inclusion
Cerebral functional connectivity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 34995332Fauve P, Tyvaert L, Husson C, Hologne E, Gao X, Maillard L, Schwan R, Banasiak C, El-Hage W, Hossu G, Hingray C. Functional MRI-based study of emotional experience in patients with psychogenic non-epileptic seizures: Protocol for an observational case-control study-EMOCRISES study. PLoS One. 2022 Jan 7;17(1):e0262216. doi: 10.1371/journal.pone.0262216. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI (functional Magnetic Resonance Imaging) and psychiatric evaluation in people with Psychogenic Non-epileptic Seizures, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: 6 months after the last inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.