Mindfulness Meditation for Epilepsy (MIME)

Mindfulness Meditation for Epilepsy: Effect of Mindfulness Meditation Practice on Quality of Life and EEG Activity in Refractory Epilepsy

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Healthy Subjects
• Intervention / Treatment: Behavioral: Therapeutic education; Behavioral: Mindfulness meditation training

Detailed Description

Through the development of standardized protocols, mindfulness meditation has been introduced as a complementary treatment to prevent the relapse of depression, and to reduce stress and improve well-being in many chronic conditions.

Epilepsy, which results from the activity of hyperexcitable circuits, is also associated with a disorganization of the physiological brain networks. Studies in cognitive neuroscience in healthy subjects suggest that meditation induces lasting changes in the physiological networks of attention and default mode and could potentially compensate for dysfunctions of these networks in epileptic patients.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Centre hospitalier universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Therapeutic education group; 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; 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.
Experimental: Mindfulness meditation group; 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; 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...).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form Quality of Life Questionnaire (SF36) score at 1 months	Change in the score on the Short Form Quality of Life Questionnaire (SF36) assessed before the intervention and at 1 month. 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 1 month
Depressive symptoms assessed on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month	MADRS score is evaluated before the intervention and at 1 month. Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;	At inclusion and at 1 month
Depressive symptoms assessed on the Evolution of MADRS score at 3 months	MADRS score is evaluated before the intervention and at 3 months. Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;	At inclusion and at 3 months
Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 1 month	NDDI-E score is evaluated before the intervention and at 1 month. Depression scale score 0 to 24	At inclusion and at 1 month
Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 3 months	NDDI-E score is evaluated before the intervention and at 3 months. Depression scale score 0 to 24	At inclusion and at 3 months
Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 1 month.	Scores on the State-Trait Anxiety Inventory scale (STAI A and B) evaluated before the intervention and at 1 month. STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;	At admission and at 1 month
Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 3 months.	Scores on the State-Trait Anxiety Inventory scale (STAI-Y A and B) evaluated before the intervention and at 3 months. STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;	At inclusion and at 3 months
Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.	Scores on GAD-7 scale evaluated before the intervention and at 1 month. Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.	At admission and at 1 month
Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.	Scores on GAD-7 scale evaluated before the intervention and at 3 months. Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.	At admission and at 3 months
Seizure frequency at 1 month	Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.	At 1 month
Seizure frequency at 3 month	Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.	At 3 month
EEG network analysis	Comparison of EEG resting state networks between patients and healthy controls. Networks are assessed with EEG functional connectivity measures	Between inclusion and 3 months (M3)

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Laboratoire Traitement du Signal et de l'Image, INSERM UMR1099 Rennes; Centre Hospitalier Guillaume Régnier, RENNES
• Investigators: Study Chair: Isabelle MERLET, PhD, LTSI - INSERM UMR 1099

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): June 6, 2024
• Study Completion (Actual): June 23, 2024

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness meditation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 35RC20_8848; 2020-A02336-33 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified data supporting the findings of this study will be available upon reasonable request and in compliance to with European Regulations.

Psychometric scale scores, socio-demographic and clinical data will be made available when analysis of outcomes are completed (approximately two years after princeps publication).

EEG data will be shared when all additionnal electrophysiological studies are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No