Mindfulness Meditation for Epilepsy

NCT04687904 | Completed

• 2 other identifiers: 35RC20_88482020-A02336-33
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

In one-third of epileptic patients treated in France, seizures persist despite drug treatment. These so-called "refractory" epilepsies are among the most severe. Only a minority of patients with refractory epilepsy can undergo surgery. The other options available are based on brain or vagus nerve stimulation interventions which clinical effectiveness is still being studied. Alternative therapies are needed both to decrease the frequency of patients' seizures and to improve their quality of life. The practice of mindfulness meditation has recently been included in the recommendations of the International League Against Epilepsy in order to alleviate anxiety or depression comorbid symptoms. This study falls within this framework by targeting two aspects of the pathology.

Conditions

Healthy Subjects; Epilepsy

Keywords

Mindfulness meditation

Outcome Measures

Primary Outcomes (1)

• Short Form Quality of Life Questionnaire (SF36) score at 3 months

  Change in the score on the Short Form Quality of Life Questionnaire (SF36) assessed before the intervention and at 3 months. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  At inclusion and at 3 months

Secondary Outcomes (12)

• Short Form Quality of Life Questionnaire (SF36) score at 1 months

  At inclusion and at 1 month

• Depressive symptoms assessed on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month

  At inclusion and at 1 month

• Depressive symptoms assessed on the Evolution of MADRS score at 3 months

  At inclusion and at 3 months

• Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 1 month

  At inclusion and at 1 month

• Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 3 months

  At inclusion and at 3 months

Study Arms (2)

Therapeutic education group

ACTIVE COMPARATOR

The psychologist associated with the project takes care of the patient to receive a 1.5 hour therapeutic education interview ("control" group).

Behavioral: Therapeutic education

Mindfulness meditation group

EXPERIMENTAL

The psychologist associated with the project takes care of the patient to receive training in mindfulness meditation twice (1.5 hours) ("active" group)

Behavioral: Mindfulness meditation training

Interventions

Mindfulness meditation training BEHAVIORAL

Patients will be able to benefit from mindfulness meditation training at the rate of 1h30 in the morning and 1h30 in the afternoon. During this training, patients will be invited to share with the psychologist their vision of mindfulness meditation and their expectations of this practice. The psychologist will then introduce what mindfulness is and how the sessions will take place. Several sessions guided by the psychologist will then be offered to the patient (body scan, focused attention, mindfulness movements...).

Mindfulness meditation group

Therapeutic education BEHAVIORAL

Patients will benefit from a 2-hour interview which will be conducted by the psychologist associated with the project. The aim of this interview is to help patients better understand their disease in order to adopt the right behaviors on a daily basis. This session will inform patients about their disease, its origins, its treatment, the difficulties it causes and the means to remedy it. The objective of this session is to better understand and manage epilepsy and to enable patients to take an active part in the process of care and management of the disease. No specific instructions will be given at the end of this interview.

Therapeutic education group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients :
• Patients over 16 years of age;
• Epilepsy refractory to drug treatment according to the consensus criteria of the International League Against Epilepsy ;
• Affiliated with a health insurance plan;
• Free, informed and written consent signed by the patient, and parents for patients under the age of 18.
• For healthy subjects :
• Healthy subjects 16 years of age and older;
• Affiliated with a health insurance plan;
• Free, informed and written consent signed by the volunteer, or parents, for volunteers under the age of 18.

You may not qualify if:

• For patients :
• Alcohol Addiction Disorders (assessed by the Mini-International Neuropsychiatric Interview (MINI) scale) ;
• Patients with psychogenic crises;
• Treatment with antidepressants;
• Simultaneous participation in other research that may interfere with the protocol;
• Persons of legal age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
• For healthy subjects :
• Psychiatric pathology and/or alcohol addiction disorders (evaluated by the MINI scale) ;
• Simultaneous participation in other research that may interfere with the protocol;
• Persons of legal age subject to legal protection (protection of justice, guardianship, trusteeship), persons deprived of liberty.

Sponsors & Collaborators

• Rennes University Hospital: lead
• Laboratoire Traitement du Signal et de l'Image, INSERM UMR1099 Rennes: collaborator
• Centre Hospitalier Guillaume Régnier, RENNES: collaborator

Study Sites (1)

Centre Hospitalier Universitaire

Rennes, 35033, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Isabelle MERLET, PhD

  LTSI - INSERM UMR 1099

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Psychiatrists responsible for psychiatric assessments (MH, DD, SM) remained blinded to group allocation throughout the study and during the analysis of psychometric rating scales.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20 Patients with drug resistant epilepsia and 17 healthy volonteers (out of 20 expected) were included. Volonteers had only an EEG examination to constitue the control group for the secondary outcome measure regarding EEG resting state analysis

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 29, 2020
• Study Start: January 14, 2021
• Primary Completion: June 6, 2024
• Study Completion: June 23, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)