Mindfulness Meditation for Epilepsy (MIME)

Rennes University Hospital

Status: Enrolling

Conditions: Epilepsy

Treatments: Behavioral: Mindfulness meditation training; Behavioral: Therapeutic education

Study type: Interventional

Funder types: Other

Identifiers

NCT04687904

35RC20_8848

2020-A02336-33 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Therapeutic education group

Active Comparator group

Description:

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

Treatment:

Behavioral: Therapeutic education

Mindfulness meditation group

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness meditation training