Last updated: March 13, 2024
Sponsor: Central Hospital, Nancy, France
Overall Status: Completed
Phase
N/A
Condition
Somatoform And Dissociative Disorders
Treatment
psychiatric evaluation
fMRI (functional Magnetic Resonance Imaging)
Clinical Study ID
NCT02976545
2016-A01295-46
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 symptomsanalysis and video-EEG recording,
- Absence of concomitant epilepsy. Specific Inclusion Criteria for PTSD group : PTSD diagnosed by a psychiatrist, based onclinical symptoms as recorded in DSM5 (Diagnostic and Statistical Manual of MentalDisorders). Specific Inclusion Criteria for healthy controls : Healthy controls will be paired up withpatients on age and level of schooling criteria.
Exclusion
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 amonth,
- 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 ofPublic 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 thepatient. Specific exclusion Criteria for PTSD group :
- Diagnosis of PTSD challenged or denied by the patient, current or history offunctional neurological symptom disorder,
- History of PNES (conversion disorder). Specific exclusion Criteria for healthy controls :
- History of PTSD,
- History of PNES (conversion disorder).
Study Design
Total Participants: 68
Treatment Group(s): 2
Primary Treatment: psychiatric evaluation
Phase:
Study Start date:
October 03, 2017
Estimated Completion Date:
September 30, 2022
Connect with a study center
CHRU de Nancy
Nancy, 54000
FranceSite Not Available
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