Quality of Life and Psychogenic Nonepileptic Seizures.

NCT02821208 | Completed

• 1 other identifier: CHUBX 2014/04
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psychogenic Nonepileptic Seizures (PNESs)

Keywords

Psychogenic nonepileptic seizure, quality of life

Outcome Measures

Primary Outcomes (1)

• Improvement of the quality of life measured by the self-administered questionnaire QOLIE-31 (quality of life in epilepsy - QOLIE-31)

  6 months

Secondary Outcomes (3)

• 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

Study Arms (1)

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).

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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…

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital of Bordeaux - Hospital Pellegrin

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Psychogenic Nonepileptic Seizures

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric FRISON, Doctor

  Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: July 1, 2016
• Study Start: August 26, 2016
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)