Clinical trial NCT04687904: Mindfulness Meditation for Epilepsy
Official title: Mindfulness Meditation for Epilepsy: Effect of Mindfulness Meditation Practice on Quality of Life and EEG Activity in Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Mindfulness meditation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Laboratoire Traitement du Signal et de l'Image, INSERM UMR1099 Rennes
name: Centre Hospitalier Guillaume Régnier, RENNES
First posted: 2020-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short Form Quality of Life Questionnaire (SF36) score at 3 months
timeFrame: At inclusion and at 3 months
Secondary outcomes:
measure: Short Form Quality of Life Questionnaire (SF36) score at 1 months
timeFrame: At inclusion and at 1 month
measure: Depressive symptoms assessed on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month
timeFrame: At inclusion and at 1 month
measure: Depressive symptoms assessed on the Evolution of MADRS score at 3 months
timeFrame: At inclusion and at 3 months
measure: Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 1 month
timeFrame: At inclusion and at 1 month
measure: Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 3 months
timeFrame: At inclusion and at 3 months
measure: Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 1 month.
timeFrame: At admission and at 1 month
measure: Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 3 months.
timeFrame: At inclusion and at 3 months
measure: Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.
timeFrame: At admission and at 1 month
measure: Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.
timeFrame: At admission and at 3 months
measure: Seizure frequency at 1 month
timeFrame: At 1 month
measure: Seizure frequency at 3 month
timeFrame: At 3 month
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: LTSI - INSERM UMR 1099
name: Isabelle MERLET, PhD
role: STUDY_CHAIR
References: