Quality of Life and Psychogenic Nonepileptic Seizures. (PronoCNEP)

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

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

Study Overview

• Status: Completed
• Conditions: Psychogenic Nonepileptic Seizures (PNESs)

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • University Hospital of Bordeaux - Hospital Pellegrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Every patient who come in hospital for diagnostic of Psychogenic nonepileptic seizures (PNES)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

One cohorte : patient psychogenic nonepileptic seizures; The Psychogenic nonepileptic seizures (PNESs) are paroxysmal episodes type of abnormal movements, behavior modification or alteration of the contact-like seizures. These episodes are involuntary and underpinned by an unconscious psychological processes. In the International Classification of Disease-10 (ICD-10), they are classified as dissociative phenomena as conversing syndromes in the Manual of Diagnostic and Statistical Mental Disorders-IV (DSM-IV). The participants of the study only receive the usual care they would have if they were not included (no new/different intervention allocated in the study).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of the quality of life measured by the self-administered questionnaire QOLIE-31 (quality of life in epilepsy - QOLIE-31)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Average evolution in the quality of life measured by subscores of QOLIE -31 scale	6 months
The average change in the quality of life, measured by the self-administered questionnaire SF -36	6 months
The proportion of patients with clinically significant improvement in quality of life subscores measured by the SF-36	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Eric FRISON, Doctor, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2016
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Psychogenic nonepileptic seizure, quality of life
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: CHUBX 2014/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No