Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression

Conditions
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Emotion Regulation

Intervention / Treatment
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* Device: BCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking Geriatric Depression Scale score of 4 and below Fit to provide informed consent Able to travel to study site independently Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Affective BCI training<br>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. | Device: BCI<br>* As participants listen to the music, the EEG waves of their affective states and their variations detected in real-time is converted into an auditory signal providing direct feedback to participants about their affective states and assisting participants to learn and practice emotion regulation.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion regulation questionnaire (ERQ) | To evaluate change in ERQ scores | Week 0 and Week 9 | 
| Positive and Negative Affect Scale (PANAS) | To evaluate change in PANAS score | Week 0 and Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Assessment of Cognition - Short form | To evaluate changes in neurocognition | Week 0 and Week 9 | 
| Geriatric Depression Scale (GDS) | To evaluate change in GDS score | Week 0 and Week 9 | 
| Positive Mental Health (PMH) instrument | To evaluate change in PMH score | Week 0 and Week 9 | 
| Body Awareness Questionnaire (BAQ) | To evaluate change in BAQ | Week 0 and Week 9 | 
| Subjective Happiness Scale | To evaluate change in SHS | Week 0 and Week 9 | 
| Connor-Davidson Resilience Scale 25 (CD-RISC-25) | To evaluate change in CD-RISC-25 score | Week 0 and Week 9 | 
| The Frenchay Activities Index (FAI) | To evaluate change in FAI scores | 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 | Participants in the intervention group will rate statements regarding their satisfaction and ease of use of the training components on a 7-point Likert scale | At the end of Week 8 |