Quality of Life and Psychogenic Nonepileptic Seizures.

Psychogenic Nonepileptic Seizures (PNESs) Clinical Trial

— PronoCNEP  

Official title:

Assessment and Prognostic Factors of Quality of Life in Patients With Psychogenic Nonepileptic Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821208
• Other study ID #: CHUBX 2014/04
• Status: Completed
• Start date: August 26, 2016
• Est. completion date: June 12, 2020

Study information

• Verified date: May 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to identify the prognostic factors of quality of life in patients with psychogenic non-epileptic seizures

Description:

This is a monocentric prospective study. Our main objective is to identify prognostic factors associated with an improvement of quality of life on the QOLIE-31 and Short Form Health Survey "SF-36" at six months from the diagnostic. We hypothesized that the absence of PNES during the last three-months before the six months follow-up visit is the best prognostic factor for an improvement of quality of life All adult (>15 years and 3 months) patients diagnosed with PNES will be prospectively included. All patients will undergo standard of care and have consultation with neurologist and a psychiatrist trained for this type of disease, as it is usually made for these patients (no intervention allocated in the context of the research). . Announcement of diagnostic will be standardized and adapted to each patient. Clinical and demographic data will be collect as well as medical and psychiatric history. All patients will undergo prolonged electroencephalogram (EEG) under video monitoring allowing the diagnostic of PNES and ruling out epilepsy. Different neurologic and psychiatric scales will be collected (Quality of life in epilepsy - 31 quotes (QOLIE-31), Short Form Health Survey (SF-36), Montreal Cognitive Assessment (MoCA), Beck Depression Inventory (BDI2), Beck Anxiety index (BAI), Clinician administrated Post traumatic stress disorder scale (CAPS), Chilhood Trauma Questionnaire (CTQ), Epworth). All patients will be oriented to psychiatric or psychological follow-up. Patients will undergo a one, three and six months follow-up and will be evaluated the number of seizure, their severity, and psychiatric or psychological follow-up will be evaluated. Patients will undergo scales (QOLI-31, SF-36, BDI2, BAI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Male or female adults (15 years and 3 months old)
• Psychogenic nonepileptic seizures (PNES) diagnosed as "probable" , "clinically established" or "documented" according to "Lafrance and al." criteria
• Having benefited a prolonged electroencephalogram recording under video control
• Patient Information and collection of non-opposition (patient or legal guardian)
• The patient or caregiver will be able to perform reliably the crisis diary and make the difference between PNES and epileptic seizure after investigator or co-investigator information.
• Affiliated to a social Insurance…

Exclusion Criteria:

• Patients for whom PNES have not been diagnosed
• Refused to participate
• The patient or his caregiver isn't able to perform reliably the crisis diary and don't make the difference between PNES and epileptic seizure after investigator or co-investigator information

Related Conditions & MeSH terms

• Psychogenic Nonepileptic Seizures (PNESs)
• Seizures

Locations

Country	Name	City	State
France	University Hospital of Bordeaux - Hospital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the quality of life measured by the self-administered questionnaire QOLIE-31 (quality of life in epilepsy - QOLIE-31)		6 months
Secondary	Average evolution in the quality of life measured by subscores of QOLIE -31 scale		6 months
Secondary	The average change in the quality of life, measured by the self-administered questionnaire SF -36		6 months
Secondary	The proportion of patients with clinically significant improvement in quality of life subscores measured by the SF-36		6 months