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Clinical Trial Summary

The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Psychogenic Non Epileptic Seizure
  • Seizures

NCT number NCT02311829
Study type Interventional
Source Central Hospital, Nancy, France
Contact Louis MAILLARD, PU-PH, HDR
Phone 03 83 85 16 86
Email l.maillard@chu-nancy.fr
Status Recruiting
Phase N/A
Start date January 2014
Completion date January 2018