Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Cerebral activation in fMRI
研究概览
简要总结
Cognitive impairment is a common residual symptom after a depressive episode and expose patients to a risk of relapsing or therapeutic resistance.
Neurofeedback (using ElectroEncephaloGraphy - EEG or functional Magnetic Resonance Imaging - fMRI) allows patients to self-regulate their cerebral activity, which is supposedly provided through an intelligible and motivating feedback.
Recent results exhibited clinical improvement in depressed patients who underwent a fMRI neurofeedback protocol targeting the amygdala. Furthermore, prefrontal alpha activity was temporally correlated to variations of the BOLD signal in the amygdala. Simultaneous fMRI/EEG neurofeedback is hypothesized to potentialize its antidepressant effect.
Our objective will be to test this assumption by conducting a double-blind randomized trial, and to prove the superiority of bimodal fMRI/EEG neurofeedback over fMRI neurofeedback alone in depressed patients.
An original visual feedback will be provided and validated beforehand by a pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Aged 18 to 65 years old
- •Signature of an informed consent after being given clear and loyal oral and written information
排除标准
- •Related to the volunteer
- •Prior experience of a neurofeedback task
- •Related to the MRI
- •Implanted cardiac pacemaker of defibrillator
- •Brain aneurysm clip
- •Cochlear implant
- •Ocular on encephalic metallic foreign body
- •Endoprothesis implanted for less than 4 weeks and ostheosynthesis device implanted for less than 6 weeks.
- •Claustrophobia
- •Other criteria
- •Unstable hemodynamic status
- •Acute respiratory failure
- •Alteration of general state or continuous monitoring requirement
- •Other psychiatric condition (DSM-5) such as schizophrenia, substance abuse…
- •Neurological condition or diagnosis of dementia in medical history
- •Undergoing treatment by benzodiazepines or anticonvulsants prescribed less than a month prior to inclusion
- •Undergoing treatment influencing the blood flow prescribed less than three weeks prior to inclusion
- •Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)
研究组 & 干预措施
EEG/fMRI neurofeedback
Healthy volunteers
干预措施: EEG/fMRI neurofeedback (Other)
结局指标
主要结局
Cerebral activation in fMRI
时间窗: day 1
Measurement by an enregistrement in fMRI
EEG power in alpha band
时间窗: day 1
Measurement by an enregistrement in EEG
次要结局
- Technology prone behaviour(day 1)
- Anxious personality traits(day 1)
- Mindfulness skills(day 1)