MedDataX Logo

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

NCT ID: NCT06035965

Last Updated: 2023-12-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19)

19 items assessing post-surgery satisfaction.

Intervention Type OTHER

Quality of Life in Epilepsy Inventory (QOLIE-31)

31 items to assess different dimensions of quality of life

Intervention Type OTHER

Generalized Anxiety Disorder 7 (GAD7)

7 items, rated from 0 to 3, to detect anxiety disorders.

Intervention Type OTHER

Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)

to screen for depressive disorders

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

HELENE MIRABEL

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

HELENE MIRABEL

Role: CONTACT

Phone: 05 61 77 56 14

Email: [email protected]

AMAURY DE BARROS

Role: CONTACT

Phone: 05 61 77 90 27

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

HELENE MIRABEL

Role: primary

AMAURY DE BARROS

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC31/23/0411

Identifier Type: -

Identifier Source: org_study_id