EPICHANGE: Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06035965
Collaborator
(none)
160
1
12
13.3

Study Details

Study Description

Brief Summary

Epilepsy is one of the most common chronic neurological diseases. According to data from the World Health Organization (WHO), it affects 0.5 to 1% of the population, or around 70 million people world-wide and around 600,000 in France. There are several more or less severe forms of epilepsy depending on the type of epileptic seizures and the frequency of these seizures. About 30% of epileptic patients respond poorly to well-conducted medical treatment, which makes the number of so-called "drug-resistant" patients estimated at between 100,000 and 150,000 patients.

Epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to complete seizure control. Beyond the impact on the control of seizures, surgery can have an impact on the lives of patients at the psychological, emotional and cognitive level, with consequences on their socio-professional but also personal life. Thus the impact on the daily life of patients after epilepsy surgery can vary greatly from one patient to another and the personal feelings of operated patients do not always seem to correspond to the objective elements collected by doctors. 2.3 We want to retrospectively assess the satisfaction and quality of life of patients operated on for more than 2 years based on their epileptological results (frequency of seizures).

To our knowledge, no French study has yet studied this.

Condition or Disease Intervention/Treatment Phase
  • Other: Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19)
  • Other: Quality of Life in Epilepsy Inventory (QOLIE-31)
  • Other: Generalized Anxiety Disorder 7 (GAD7)
  • Other: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
  • Other: Evaluation of Changes in Daily Life after Epilepsy Surgery (EVOCQUE)

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery, With Long-term Epileptological Objective Results
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the changes felt by patients [2 years]

    Evaluate the changes felt by patients more than 2 years after surgery in the context of drug-resistant epilepsy using a new questionnaire created by the epileptology team of the Toulouse University Hospital.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the Toulouse University Hospital.

  • Patient covered by a social security scheme.

  • Patient having given his non-objection to participate in the research.

Exclusion Criteria:
  • Minor under the age of 15 at the time of the questionnaires.

  • Serious psychiatric pathology unrelated to epilepsy surgery.

  • Severe intellectual disability limiting responses to self-questionnaires.

  • Language barrier.

  • Patients under guardianship and protection of justice.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Toulouse Toulouse France

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: HELENE MIRABEL, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT06035965
Other Study ID Numbers:
  • RC31/23/0411
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023