Clinical trial NCT03696667: Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
Official title: Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Lead sponsor: Institute of Mental Health, Singapore
Sponsor class: OTHER
Collaborators: name: Agency for Science, Technology and Research
name: Duke-NUS Graduate Medical School
First posted: 2018-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Emotion regulation questionnaire (ERQ)
timeFrame: Week 0 and Week 9
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Week 0 and Week 9
Secondary outcomes:
measure: Brief Assessment of Cognition - Short form
timeFrame: Week 0 and Week 9
measure: Geriatric Depression Scale (GDS)
timeFrame: Week 0 and Week 9
measure: Positive Mental Health (PMH) instrument
timeFrame: Week 0 and Week 9
measure: Body Awareness Questionnaire (BAQ)
timeFrame: Week 0 and Week 9
measure: Subjective Happiness Scale
timeFrame: Week 0 and Week 9
measure: Connor-Davidson Resilience Scale 25 (CD-RISC-25)
timeFrame: Week 0 and Week 9
measure: The Frenchay Activities Index (FAI)
timeFrame: Week 0 and Week 9
measure: Medical Outcomes Study: 20-item short form survey instrument
timeFrame: Week 0 and Week 9
measure: Outcome rating scale
timeFrame: After each BCI session during Weeks 1 to 8
measure: Usability questionnaire
timeFrame: At the end of Week 8
Other outcomes:
measure: Changes in functional MRI
timeFrame: Week 0 and Week 9
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS Medical School
city: Singapore
country: Singapore
facility: Institute of Mental Health
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Jimmy Lee
role: PRINCIPAL_INVESTIGATOR
References: