Quality of Life and Psychogenic Nonepileptic Seizures. | NCT02821208

Studies
Quality of Life and Psychogenic Nonepileptic Seizures.

NCT02821208

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

May 13, 2022Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Psychogenic Nonepileptic Seizures (PNESs)

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2016Actual

Primary Completion Date

Jun 12, 2020Actual

Completion Date

Jun 12, 2020Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 28, 2016

First Posted Date

Jul 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2022

Last Update Posted Date

May 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric FRISON, Doctor	Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Bordeaux - Hospital Pellegrin		Bordeaux		33000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000091323	Psychogenic Nonepileptic Seizures

Ancestor Terms

ID	Term
D012640	Seizures
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

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Browse Branches

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