Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery (EPICHANGE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06035965 |
Recruitment Status :
Recruiting
First Posted : September 13, 2023
Last Update Posted : December 18, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 The investigators 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).
Condition or disease | Intervention/treatment |
---|---|
Epilepsy | 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 Type : | Observational |
Estimated 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 |
Actual Study Start Date : | November 30, 2023 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | December 1, 2024 |
- Other: Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19)
19 items assessing post-surgery satisfaction.
- Other: Quality of Life in Epilepsy Inventory (QOLIE-31)
31 items to assess different dimensions of quality of life
- Other: Generalized Anxiety Disorder 7 (GAD7)
7 items, rated from 0 to 3, to detect anxiety disorders.
- Other: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
to screen for depressive disorders
- Other: Evaluation of Changes in Daily Life after Epilepsy Surgery (EVOCQUE)
self-questionnaire developed by the Toulouse epileptology team in 2023 for patients who have undergone epilepsy surgery. It aims to collect the feelings of patients concerning the changes induced by surgery in their daily life according to a 7-point Likert scale.
- Evaluation of the changes felt by patients [ Time Frame: 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. The rating of the responses is distributed between 0 and 100 (0 = very negative change, 50 = no change and 100 = very positive change).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035965
Contact: HELENE MIRABEL | 05 61 77 56 14 ext +33 | mirabel.h@chu-toulouse.fr | |
Contact: AMAURY DE BARROS | 05 61 77 90 27 ext +33 | debarros.a@chu-toulouse.fr |
France | |
CHU de Toulouse | Recruiting |
Toulouse, France | |
Contact: HELENE MIRABEL MIRABEL.H@CHU-TOULOUSE.FR | |
Contact: AMAURY DE BARROS debarros.a@chu-toulouse.fr | |
Principal Investigator: HELENE MIRABEL | |
Sub-Investigator: AMAURY DE BARROS | |
Sub-Investigator: MARIE DENUELLE | |
Sub-Investigator: LUC VALTON | |
Sub-Investigator: JONATHAN CUROT |
Principal Investigator: | HELENE MIRABEL | University Hospital, Toulouse |
Responsible Party: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT06035965 |
Other Study ID Numbers: |
RC31/23/0411 |
First Posted: | September 13, 2023 Key Record Dates |
Last Update Posted: | December 18, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |