EpilepsyMIMENCT04687904
Mindfulness Meditation for Epilepsy
A study testing Mindfulness meditation training and Therapeutic education in people with Epilepsy and Healthy Subjects, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Healthy Subjects
- What is being tested?
- Mindfulness meditation training and Therapeutic education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to 23 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 :
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy, Healthy Subjects
- Being tested
- Mindfulness meditation training, Therapeutic education
- Keywords
- Mindfulness meditation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation trainingBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Behavioral: Mindfulness meditation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion and at 3 months
Secondary outcomes (12)
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.
Measured: 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 ;
Measured: 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 ;
Measured: 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
Measured: 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
Measured: 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;
Measured: 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;
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 1 month
Seizure frequency at 3 month
Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.
Measured: 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
Measured: Between inclusion and 3 months (M3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start14 Jan 2021
- Primary completion6 Jun 2024
- Study completion23 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rennes, Centre Hospitalier Guillaume Régnier, RENNES
- Responsible party
- Sponsor
- Investigators
- Isabelle MERLET, PhD, Study chair, LTSI - INSERM UMR 1099
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687904
- Sponsor's protocol ID
- 35RC20_8848
- Other IDs
- 2020-A02336-33
- Acronym
- MIME
- Status last verified
- Feb 2026
- First submitted
- 18 Dec 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation for Epilepsy: Effect of Mindfulness Meditation Practice on Quality of Life and EEG Activity in Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT04687904
- Acronym / sponsor ID
- MIME / 35RC20_8848
- Conditions
- Epilepsy, Healthy Subjects
- Keywords
- Mindfulness meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- University of Rennes, Centre Hospitalier Guillaume Régnier, RENNES
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Therapeutic education group | Active comparator | Behavioral: Therapeutic educationThe psychologist associated with the project takes care of the patient to receive a 1.5 hour therapeutic education interview ("control" group). |
| Mindfulness meditation group | Experimental | Behavioral: Mindfulness meditation trainingThe psychologist associated with the project takes care of the patient to receive training in mindfulness meditation twice (1.5 hours) ("active" group) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- For patients :
- For healthy subjects :
Key exclusion criteria (10 listed)
- For patients :
- For healthy subjects :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditation trainingPatients 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...). | Behavioural | Mindfulness meditation group |
| Therapeutic educationPatients 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. | Behavioural | Therapeutic education group |
Primary outcome
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.
12 secondary outcomes
Short Form Quality of Life Questionnaire (SF36) score at 1 months
Time frame: At inclusion and at 1 month
Depressive symptoms assessed on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month
Time frame: At inclusion and at 1 month
Depressive symptoms assessed on the Evolution of MADRS score at 3 months
Time frame: At inclusion and at 3 months
Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 1 month
Time frame: At inclusion and at 1 month
Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 3 months
Time frame: At inclusion and at 3 months
Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 1 month.
Time frame: At admission and at 1 month
Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 3 months.
Time frame: At inclusion and at 3 months
Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.
Time frame: At admission and at 1 month
Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.
Time frame: At admission and at 3 months
Seizure frequency at 1 month
Time frame: At 1 month
Seizure frequency at 3 month
Time frame: At 3 month
EEG network analysis
Time frame: Between inclusion and 3 months (M3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle MERLET, PhD study chair
LTSI - INSERM UMR 1099
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation training and Therapeutic education in people with Epilepsy and Healthy Subjects, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Quality of Life Questionnaire (SF36) score at 3 months (time frame: At inclusion and at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.