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

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.

Study Overview

• Status: Completed
• Conditions: Emotion Regulation
• Intervention / Treatment: Device: BCI

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169857
    • Duke-NUS Medical School
  • Singapore, Singapore, 539747
    • Institute of Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Device: BCI; 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.
NO_INTERVENTION: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in functional MRI	To examine the neural mechanism underlying the intervention	Week 0 and Week 9

Collaborators and Investigators

• Sponsor: Institute of Mental Health, Singapore
• Collaborators: Duke-NUS Graduate Medical School; Agency for Science, Technology and Research
• Investigators: Principal Investigator: Jimmy Lee, Institute of Mental Health, Singapore

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2018
• Primary Completion (ACTUAL): September 26, 2018
• Study Completion (ACTUAL): September 26, 2018

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (ACTUAL): October 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2017/00297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No