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临床试验/NCT01945372
NCT01945372Unknown不适用

Self-modulation of Prefrontal Alpha Asymmetry:Novel Neurofeedback Treatment of Affective Instability in Premenstrual Dysphoric Disorder(PMDD)

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
PMDD symptoms

研究概览

简要总结

Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to patients' functioning and quality of life, ~40% do not respond to conventional treatment options.

In this study, the investigators aim to examine a novel therapeutic approach for the treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF) probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either a real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after training period. Comprehensive psychological assessment will be performed for outcome measure. The investigators hypothesize that EEG-NF treatment will enhance affective stability, thus improving patients' daily lives.

详细描述

Epidemiological and clinical studies consistently show that approximately 2-8% of all premenopausal women suffer from premenstrual dysphoric disorder (PMDD) - a serious pattern of distressing symptoms beginning at the luteal phase of the menstrual cycle and terminating shortly after the onset of menses. The most common psychological symptoms reported by women with PMDD are mood lability and irritability, and to a lesser extent a depressed mood or diminished interest and pleasure. In contrast to the milder premenstrual syndrome (PMS), PMDD is a severe mental disorder which can in some cases even trigger suicidal thoughts and attempts. Sadly, many women do not respond to currently available pharmacological treatments, while others suffer from their side effects throughout the month.

The proposed study aims to examine the clinical effectiveness of a novel therapeutic approach for treating emotional instability in PMDD. The investigators plan to use a clinical model of weekly brain-guided training (i.e. NeuroFeedBack, NF) to gain better self control of affect and its regulation. Feedback will be based on modulating pre-frontal EEG Alpha waves, a technique shown in prior studies to have a therapeutic effect in affective symptoms; however the brain circuitry which underlies such effects is largely unknown. By using simultaneous fMRI and EEG the investigators intend to unveil the neural correlates of response to such treatment and to provide new markers for clinical trajectory in PMDD.

Prospectively diagnosed PMDD women will be randomly assigned to either a real or sham EEG-NF protocol. During the training, patients will be instructed to "Think Positively" in order to actively manipulate brain areas that are related to positive experiences, while viewing a stream of various faces with different expressions. Following each facial image, feedback based on the alpha asymmetry score will be given to the patient regarding their ability to generate positive thoughts during the stream of faces. However, only the women within study group will receive accurate feedback. To obtain a neural and hormonal profile, patients will undergo simultaneous EEG-fMRI testing before and after training, and blood samples of hormone levels will be gathered. Comprehensive psychiatric and psychological assessment will be performed as an outcome measure.

The investigators hypothesize that the NF protocol will enhance affective stability, thus improving daily functioning and quality of life among PMDD patients, without the need for pharmacological agents, intrusive techniques or time consuming interventions. Moreover, this treatment method is individually tailored to the needs and symptoms of the patient and can be used periodically rather than continuously. The patient remains in control throughout the procedure, and can potentially learn to use this technique on a continuous basis, beyond the scope of the clinical trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

EEG NeuroFeedback - real feedback

Experimental

Thw women in the experimental group will receive accurate realtime feedback corresponding to their performance on the task.

干预措施: EEG NeuroFeedback (Other)

EEG NeuroFeedback - sham feedback

Sham Comparator

The women in the sham group will receive neural feedback from another person in the study, thus unrelated to their mental practice

干预措施: EEG NeuroFeedback (Other)

结局指标

主要结局

PMDD symptoms

时间窗: Up to 24 months

Will be assessed by the score on the PMTS questionnaire before, during and after the intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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