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Completed

NCT Number: NCT04687904

Mindfulness Meditation for 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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Healthy Subjects Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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...).

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.

Primary outcomes

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

    Time frame: At inclusion and 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.

Secondary outcomes

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

    Time frame: At inclusion and at 1 month

    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.

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

    Time frame: At inclusion and 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 ;

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

    Time frame: At inclusion and 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 ;

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

    Time frame: At inclusion and at 1 month

    NDDI-E score is evaluated before the intervention and at 1 month. Depression scale score 0 to 24

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

    Time frame: At inclusion and at 3 months

    NDDI-E score is evaluated before the intervention and at 3 months. Depression scale score 0 to 24

  6. Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 1 month.

    Time frame: At admission and 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;

  7. Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 3 months.

    Time frame: At inclusion and 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;

  8. Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.

    Time frame: At admission and 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.

  9. Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.

    Time frame: At admission and at 3 months

    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.

  10. Seizure frequency at 1 month

    Time frame: At 1 month

    Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.

  11. Seizure frequency at 3 month

    Time frame: At 3 month

    Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.

  12. EEG network analysis

    Time frame: Between inclusion and 3 months (M3)

    Comparison of EEG resting state networks between patients and healthy controls. Networks are assessed with EEG functional connectivity measures

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Centre Hospitalier Guillaume Régnier, RENNES
  • University of Rennes

Registry information

Official study title

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

Acronym: MIME

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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