Clinical Trial: Quality of Life and Psychogenic Nonepileptic Seizures.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary:

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).


Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Improvement of the quality of life measured by the self-administered questionnaire QOLIE-31 (quality of life in epilepsy - QOLIE-31) [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: June 22, 2016
Date Started: August 2016
Date Completion: June 2018
Last Updated: September 7, 2016
Last Verified: September 2016