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Completed

NCT Number: NCT02821208

Quality of Life and 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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Bordeaux - Hospital Pellegrin

Bordeaux, 33000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Average evolution in the quality of life measured by subscores of QOLIE -31 scale

    Time frame: 6 months

  2. The average change in the quality of life, measured by the self-administered questionnaire SF -36

    Time frame: 6 months

  3. The proportion of patients with clinically significant improvement in quality of life subscores measured by the SF-36

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: PronoCNEP

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2016
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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