Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Emotion regulation questionnaire (ERQ)
研究概览
简要总结
The primary objective is to examine the feasibility and efficacy of a locally developed brain-computer interface (BCI) based system training for regulating mood in healthy elderly. The investigators hypothesize that elderly who complete the training program will be better at regulating emotions as compared to controls, based on their ratings of the primary outcome measures.
详细描述
In this project, we will leverage on a locally developed electroencephalograph (EEG)-based BCI technology for decoding affective states of the brain, and thereby develop a closed-loop sensing and stimulation mechanism. The technology uses advanced neural signal computing on the EEG in real-time and audio feedback using a machine learning model that associates individual user's EEG characteristics in relation to music-emotion features. The system is portable and will allow emotion regulation training to be done outside of hospital setting with ease thus potentially addressing the treatment gap for MDD in the elderly.
This is a two group randomized study. One group will undergo the intervention which is 24 sessions of BCI emotion regulation training (i.e. listening to music with audio feedback to regulate emotions towards positive affect) over an 8-week period. The control group will undergo 8 weeks of music sessions, without any emotion regulation training. Both groups will undergo pre- and post- psychometric assessments looking at cognition, quality of life, functioning and emotional states. This study will also carry out functional MRI of the brain before and after 8 weeks of either training (intervention) or music music session (control) to examine changes associated with the affective BCI training. Study findings derived from psychometric assessments, EEG analysis and neuroimaging will provide evidences on efficacy and usability of this technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-speaking
- •Geriatric Depression Scale score of 4 and below
- •Fit to provide informed consent
- •Able to travel to study site independently
排除标准
- •Presence of hearing impairment
- •Presence of any known neuropsychiatric disorders (e.g. dementia, epilepsy or mental retardation)
- •Contraindications for MRI such as surgical clips, cardiac pacemakers, metal implants and plates, orthodontics and claustrophobia
研究组 & 干预措施
Affective BCI training
15 participants in the intervention group will undergo 24 sessions of BCI-based emotion regulation training over an 8-week period. Each session will take about 30-minute to complete where participants will listen to music with audio feedback to regulate emotions toward positive affect.
干预措施: BCI (Device)
Control group
15 participants in the control group will take part in 24 music sessions (with no audio feedback) over an 8-week period. Each session will take about 30-minute to complete.
结局指标
主要结局
Emotion regulation questionnaire (ERQ)
时间窗: Week 0 and Week 9
To evaluate change in ERQ scores
Positive and Negative Affect Scale (PANAS)
时间窗: Week 0 and Week 9
To evaluate change in PANAS score
次要结局
- Brief Assessment of Cognition - Short form(Week 0 and Week 9)
- Geriatric Depression Scale (GDS)(Week 0 and Week 9)
- Positive Mental Health (PMH) instrument(Week 0 and Week 9)
- Body Awareness Questionnaire (BAQ)(Week 0 and Week 9)
- Subjective Happiness Scale(Week 0 and Week 9)
- Connor-Davidson Resilience Scale 25 (CD-RISC-25)(Week 0 and Week 9)
- The Frenchay Activities Index (FAI)(Week 0 and Week 9)
- Medical Outcomes Study: 20-item short form survey instrument(Week 0 and Week 9)
- Outcome rating scale(After each BCI session during Weeks 1 to 8)
- Usability questionnaire(At the end of Week 8)