Real-time fMRI Neurofeedback as Treatment for Inter-critical Mood Symptoms in Bipolar Disorder : a Randomized Controlled Multicentric Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Changes in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
Bipolar Disorder (BD) is a severe mood disorder affecting between 1% and 3% of the general population. It is characterized by the succession of depressive and manic episodes, with periods of stabilization during which patients may present "residual" depressive or anxious symptoms, which are characterized by sadness and emotional hyper-reactivity. Although subthreshold, these residual symptoms are very disabling for their daily lives and are associated with the risk of recurrence and poor global functioning. The effect of pharmacological and psychotherapeutic treatments is demonstrated in the management of acute episodes but remains insufficient on residual symptoms. Therefore, there are so far few therapeutic options to target the inter-episode residual symptoms in BD. One novel approach is the real-time functional magnetic resonance imaging (fMRI) neurofeedback (NFB), which has already been shown to be an efficient method for self-regulating brain function, behavior and treating depression.
Hypothesis/Objective :
This study aims at assessing the efficacy of 3-weeks neurofeedback training with real-time fMRI on the treatment of residual mood symptoms in patients with BD. The investigators will specifically target depressive symptoms by training the patients to regulate the emotional network hemodynamic response to emotional stimuli.
Method :
The investigators will include 64 stabilized patients with BD. The investigators will recruit them in three French expert centers for BD and will randomly assign them to the experimental group, receiving feedback from the emotional brain network hemodynamic activity, or to the control group, receiving the signal from control brain areas not involved in emotion processing. Both groups will be trained to regulate their brain activity while they are presented with negatively valenced emotional pictures, based on the neurofeedback shown immediately after the trial. They will continue their usual treatment (as prescribed) throughout the duration of the study. Clinical scales and cognitive tests will enable us to evaluate the symptomatic, emotional, and cognitive changes after NFB training. The investigators will also measure resting-state functional connectivity and brain morphology before and after NFB to assess brain plasticity and to explore the neural mechanisms associated with successful regulation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with bipolar disorder I or II (DSM-5 criteria);
- •Aged between ≥ 18 and ≤ 65;
- •Absence of major mood episode for at least 3 months before inclusion (MADRS scores < 12; YMRS score < 10);
- •Presence of residual depressive symptoms, as assessed by the MADRS (score > 5);
- •Stabilized dose of mood stabilizer medication for at least 3 months before inclusion.
- •Written consent
- •Affiliation to a social security system
- •Effective contraception for women of childbearing age
排除标准
- •Severe physical disorders that may be life-threatening;
- •Major psychiatric (Axis 1) comorbidities except for anxiety disorders;
- •Any current substance abuse except for tobacco or cannabis. Substance abuse will be defined by the DSM V criteria;
- •Exclusion criteria applicable to MRI Panic disorder, claustrophobia, epilepsy Pace maker or neuronal stimulator, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical arterial material, non removable removable magnetizable metallic material
- •Somatic disorder that may affect cognitive abilities and brain structures (e.g., HIV infection, MS, lupus, Parkinson's disease, epilepsy, dementia...);
- •Ongoing non-pharmacological treatment: structured psychotherapeutic interventions (Cognitive Behavioral Therapy - CBT, Interpersonal and Social Rhythm Therapy - IPSRT) as well as brain stimulation techniques (Electroconvulsive Therapy - ECT, Transcranial Magnetic Stimulation - TMS, Deep Brain Stimulation - DBS);
- •Subject included in clinical and / or therapeutic experimentation in progress.
- •Patients under legal protection
- •Prisoners
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
Active feedback
Group receiving "real" neurofeedback (NFB) (activity of the emotional brain network)
干预措施: Real-time fMRI Neurofeedback (Other)
Sham feedback
Group receiving "sham" NFB (activity from brain regions not implicated in emotion processing) to control for a potential placebo effect.
干预措施: Real-time fMRI Neurofeedback (Other)
结局指标
主要结局
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline, 3 weeks.
Evaluation of depressive symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.
次要结局
- Montgomery and Asberg Depression Rating Scale (MADRS)(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- Young Mania Rating Scale (YMRS)(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- Bipolar Depression Rating Scale (BDRS)(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- State-Trait Anxiety Inventory (STAI A-B)(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- Multidimensional Assessment of Thymic States - MAThyS(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- Affective Intensity Measure - AIM(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- Affective Lability Scale - ALS(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- Cognitive Emotion Regulation Questionnaire - CERQ(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- Quality of life scale - QOLS(Baseline, 3 weeks, and 4, 8 weeks after the end of the training. .)
- Five Facets Mindfulness Questionnaire - FFMQ(Baseline, 3 weeks and 4, 8 weeks after the end of the training.)
- Global functioning assessment - GAF scale(Baseline, 3 weeks, and 4, 8 weeks after the end of the training.)
- Questionnaire of Adherence to the technology(Baseline, 3 weeks.)
- Self-efficacy scale(Baseline, 3 weeks.)
- The choice reaction task(Baseline, 3 weeks.)
- The Ekman facial recognition test(Baseline, 3 weeks.)
- The affective bias task(Baseline, 3 weeks.)
- The Test battery for Attentional Performance (TAP)(Baseline, 3 weeks.)
- MRI T1-T2 weighted scan(Baseline, 3 weeks)
- MRI diffusion weighted scan(Baseline, 3 weeks)
- functional MRI resting-state scan(Baseline, 3 weeks)