Evaluation of a Telephone Follow-up Procedure on the Quality of Life in Psychogenic Non-epileptic Seizures
NCT ID: NCT02311829
Last Updated: 2016-03-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
136 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-01-31
Study Completion Date
2018-01-31
Brief Summary
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The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.
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Detailed Description
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This study is a multicenter, non-drug therapy and randomized research trial, comparing a group of patients integrating the phone monitoring device (DST group) to a control group where patients are cared for in the usual way.
Subject recruiting modalities:
The study population represents patients diagnosis, PNES confirmed by following by the video-EEG, recorded in a center of epilepsy and in different CHU and informed of the diagnosis of PNES in a standardized manner.
Patients were recruited during their hospitalization video-EEG is conducted in part of the diagnostic workup of drug-resistant epilepsies, or demonstrations paroxysmal undetermined which may prove to be PNES.
Usual care:
After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannual with the neurologist.
In the study:
* For patients in both groups: Management usual care and, in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannually for 24 months after the appointment with the neurologist.
* For patients in the DST group only: Phone calls by psychologist at J 15, at 2 months, then every 2 months until M12. The device telephone follow (DST) consists of telephone calls (D15, M2, then every 2 months until M12) of the patient by an external independent psychologist designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended.
Subject recruiting modalities:
The study population represents patients diagnosis, PNES confirmed by following by the video-EEG, recorded in a center of epilepsy and in different CHU and informed of the diagnosis of PNES in a standardized manner.
Patients were recruited during their hospitalization video-EEG is conducted in part of the diagnostic workup of drug-resistant epilepsies, or demonstrations paroxysmal undetermined which may prove to be PNES.
Usual care:
After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannual with the neurologist.
In the study:
* For patients in both groups: Management usual care and, in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannually for 24 months after the appointment with the neurologist.
* For patients in the DST group only: Phone calls by psychologist at J 15, at 2 months, then every 2 months until M12. The device telephone follow (DST) consists of telephone calls (D15, M2, then every 2 months until M12) of the patient by an external independent psychologist designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended.
Conditions
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Psychogenic Non Epileptic Seizure
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Telephone follow-up device (DST)
An external independent clinical psychologist is responsible for calling regular the patient included in DST-arm.
Telephone follow-up device(DST) consists of telephone calls at 15 day, 2 month and then every 2 months until 12 months. The clinical psychologist is designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended.
Group Type
EXPERIMENTAL
Telephone follow-up device
Intervention Type
OTHER
For patients in the DST group only: Phone calls by clinical psychologist at J 15 at 2, then every 2 months until M12.
Group control ; usual care
\- Usual care: After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannually with the neurologist
\- For patients in both groups: in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannual for 24 months after the appointment with the neurologist.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Telephone follow-up device
For patients in the DST group only: Phone calls by clinical psychologist at J 15 at 2, then every 2 months until M12.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patient above 18 years old
* Affiliation to social security
* Evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years
* Diagnosis of PNES (associated or not with epilepsy) or laid confirmed following a video-EEG examination
* Standardized announcement of the disease made by a neurologist participant / PHRC training
* Good understanding of the French language
* Patient consented to participate in the study
* Affiliation to social security
* Evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years
* Diagnosis of PNES (associated or not with epilepsy) or laid confirmed following a video-EEG examination
* Standardized announcement of the disease made by a neurologist participant / PHRC training
* Good understanding of the French language
* Patient consented to participate in the study
Exclusion Criteria
* Acute psychiatric pathology at the time of inclusion warranting urgent hospitalization (acute suicidal risk, Table delusional ...)
* Progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...)
* A patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...)
* Simultaneous participation to another therapeutic intervention study during the first 12 months
* Progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...)
* A patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...)
* Simultaneous participation to another therapeutic intervention study during the first 12 months
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dr Coraline HINGRAY
UNKNOWN
Sponsor Role
collaborator
Pr Raymund SCHWAN
UNKNOWN
Sponsor Role
collaborator
Dr Vincent LAPREVOTE
UNKNOWN
Sponsor Role
collaborator
Dr Jean Pierre VIGNAL
UNKNOWN
Sponsor Role
collaborator
Pr Hervé VESPIGNANI
UNKNOWN
Sponsor Role
collaborator
Dr Anne THIRIAUX
UNKNOWN
Sponsor Role
collaborator
Dr Delphine RAUCHER CHENE
UNKNOWN
Sponsor Role
collaborator
Dr Martine LEMESLE
UNKNOWN
Sponsor Role
collaborator
Dr Benoît TROJAK
UNKNOWN
Sponsor Role
collaborator
Pr Edouard HIRSCH
UNKNOWN
Sponsor Role
collaborator
Pr Pierre Vidailhet
UNKNOWN
Sponsor Role
collaborator
Dr Dominique Mastelli
UNKNOWN
Sponsor Role
collaborator
Central Hospital, Nancy, France
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Louis MAILLARD, PU-PH, HDR
Role: PRINCIPAL_INVESTIGATOR
Central Hospital, Nancy, France
Locations
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Chu Strasbourg
Strasbourg, Alsace, France
Site Status
RECRUITING
Chu Dijon
Dijon, Bourgogne-Franche-Comté, France
Site Status
RECRUITING
Chu Reims
Reims, Champagne Ardennes, France
Site Status
RECRUITING
Chu Nancy
Nancy, Lorraine, France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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Reference Type
RESULT
Other Identifiers
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2012-A01580-43
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies
NCT03094793
COMPLETED
NA
Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
NCT04126369
RECRUITING
NA
Seizure Detection and Automatic Magnet Mode Performance Study
NCT01325623
COMPLETED
NA
Study of Pharmacological and Clinical Correlates of Frontal Cortical Electroencephalographic (EEG) Signal During the Induction, Maintenance and Emergence Phases of Anesthesia in Children
NCT06020599
RECRUITING
Human Intracranial Electrophysiology
NCT05529264
RECRUITING
NA
Collaborative Care in Posttraumatic Epilepsy
NCT05353452
RECRUITING
NA
Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task
NCT02409069
COMPLETED
NA
Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.
NCT02875964
COMPLETED
NA
Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies
NCT04749901
TERMINATED
NA
Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy
NCT06202196
RECRUITING
NA
Electroencephalographic Monitoring in Patients Treated by Deep Brain Stimulation
NCT03114748
UNKNOWN
NA
MEG Versus EEG HR for the Localization of the Epileptogenic Zone as Part of the Pre-surgical Assessment of Epilepsy
NCT03893916
RECRUITING
NA
Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies
NCT06212609
RECRUITING
NA
Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
NCT03244345
UNKNOWN
NA
Rehabilitative Trial for the Rescue of Neurophysiological Parameters in Progranulin Deficient Subjects
NCT02999282
COMPLETED
NA
Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
NCT04653012
RECRUITING
NA
Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database
NCT02107989
RECRUITING
Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
NCT06334952
RECRUITING
NA
Transcranial Stimulation During Sleep to Improve Cognition in Epilepsy
NCT02268591
WITHDRAWN
NA