Psychogenic Non Epileptic Seizure
Conditions
Keywords
Quality of life, PNES, Epilepsy,
Brief summary
The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.
Detailed description
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.
Interventions
OTHERTelephone 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.
Sponsors
Dr Coraline HINGRAY
Pr Raymund SCHWAN
Dr Vincent LAPREVOTE
Dr Jean Pierre VIGNAL
Pr Hervé VESPIGNANI
Dr Anne THIRIAUX
Dr Delphine RAUCHER CHENE
Dr Martine LEMESLE
Dr Benoît TROJAK
Pr Edouard HIRSCH
Pr Pierre Vidailhet
Dr Dominique Mastelli
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of quality of life scores every 6 months (From 6 to 24 months) | 24 months | The primary endpoint is the assessment of quality of life scores measured at 6, 12, 18 and 24 months after start of treatment (visit D0) by self-administered questionnaires of quality of life (SF-36 general questionnaire quality of life) and QOLIE 31 (specific questionnaire epilepsy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of non epileptic seizures per month | 24 months (average for 6 months) | Seizures diaries follow |
| Severity of seizures | 24 months | Duration, injuries, loss of urine and feces, fall, loss of consciousness and subjective control feel of the listed crisis between 0 and 10 on EVA scale crisis control feel. |
| Psychiatric symptomology scores | 24 months | Questionnaires (DSM-IV, Beck 21, MADRS, HAMA, DES, SDQ-20, TAS 20, Brief COPE) |
| Percentage of programmed psychological consultation and actually honored in medical and psychological center | 24 months | This percentage is collected in medical and psychological center or from liberal psychiatrist \\ psychologist (collected with phone call) |
| Number of urgent consultations or unprogrammed and \ or unprogrammed | 24 months | consultations ( SAMU, emergency, reanimation, unprogrammed neurological consultations). |
Countries
France
Contacts
Primary ContactLouis MAILLARD, PU-PH, HDR
Backup ContactCoraline HINGRAY, PU-PH
Outcome results
None listed