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Quality of Life and Psychogenic Nonepileptic Seizures.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02821208
Acronym
PronoCNEP
Enrollment
72
Registered
2016-07-01
Start date
2016-08-26
Completion date
2020-06-12
Last updated
2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychogenic Nonepileptic Seizures (PNESs)

Keywords

Psychogenic nonepileptic seizure, quality of life

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 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).

Interventions

None listed

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Average evolution in the quality of life measured by subscores of QOLIE -31 scale6 months
The average change in the quality of life, measured by the self-administered questionnaire SF -366 months
The proportion of patients with clinically significant improvement in quality of life subscores measured by the SF-366 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026