Mindfulness Meditation for Epilepsy: Effect of Mindfulness Meditation Practice on Quality of Life and EEG Activity in Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Short Form Quality of Life Questionnaire (SF36) score at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Psychiatrists responsible for psychiatric assessments (MH, DD, SM) remained blinded to group allocation throughout the study and during the analysis of psychometric rating scales.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Therapeutic education (Behavioral)
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)
干预措施: Mindfulness meditation training (Behavioral)
结局指标
主要结局
Short Form Quality of Life Questionnaire (SF36) score at 3 months
时间窗: 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.
次要结局
- Seizure frequency at 1 month(At 1 month)
- Seizure frequency at 3 month(At 3 month)
- Short Form Quality of Life Questionnaire (SF36) score at 1 months(At inclusion and at 1 month)
- Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.(At admission and at 3 months)
- Depressive symptoms assessed on the Evolution of MADRS score at 3 months(At inclusion and at 3 months)
- Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 1 month(At inclusion and at 1 month)
- Depressive symptoms assessed on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month(At inclusion and at 1 month)
- Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 3 months(At inclusion and at 3 months)
- Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 1 month.(At admission and at 1 month)
- Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 3 months.(At inclusion and at 3 months)
- Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.(At admission and at 1 month)
- EEG network analysis(Between inclusion and 3 months (M3))