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

• ClinicalTrials.gov Identifier: NCT03696667
• Recruitment Status: Completed
• First Posted: October 5, 2018
• Last Update Posted: October 5, 2018
• Sponsor: Institute of Mental Health, Singapore
• Collaborators: Agency for Science, Technology and Research; Duke-NUS Graduate Medical School
• Information provided by (Responsible Party): Institute of Mental Health, Singapore

Tracking Information

• First Submitted Date: October 3, 2018
• First Posted Date: October 5, 2018
• Last Update Posted Date: October 5, 2018
• Actual Study Start Date: March 8, 2018
• Actual Primary Completion Date: September 26, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 3, 2018)

• Emotion regulation questionnaire (ERQ) [ Time Frame: Week 0 and Week 9 ]
  To evaluate change in ERQ scores
• Positive and Negative Affect Scale (PANAS) [ Time Frame: Week 0 and Week 9 ]
  To evaluate change in PANAS score

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 3, 2018)

• Brief Assessment of Cognition - Short form [ Time Frame: Week 0 and Week 9 ]
  To evaluate changes in neurocognition
• Geriatric Depression Scale (GDS) [ Time Frame: Week 0 and Week 9 ]
  To evaluate change in GDS score
• Positive Mental Health (PMH) instrument [ Time Frame: Week 0 and Week 9 ]
  To evaluate change in PMH score
• Body Awareness Questionnaire (BAQ) [ Time Frame: Week 0 and Week 9 ]
  To evaluate change in BAQ
• Subjective Happiness Scale [ Time Frame: Week 0 and Week 9 ]
  To evaluate change in SHS
• Connor-Davidson Resilience Scale 25 (CD-RISC-25) [ Time Frame: Week 0 and Week 9 ]
  To evaluate change in CD-RISC-25 score
• The Frenchay Activities Index (FAI) [ Time Frame: Week 0 and Week 9 ]
  To evaluate change in FAI scores
• Medical Outcomes Study: 20-item short form survey instrument [ Time Frame: Week 0 and Week 9 ]
• Outcome rating scale [ Time Frame: After each BCI session during Weeks 1 to 8 ]
• Usability questionnaire [ Time Frame: At the end of Week 8 ]
  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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 3, 2018)

Changes in functional MRI [ Time Frame: Week 0 and Week 9 ]

To examine the neural mechanism underlying the intervention

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
• Official Title: Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Device Feasibility
• Condition: Emotion Regulation

Intervention

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.

Study Arms

• 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.
  Intervention: Device: BCI
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 3, 2018): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 26, 2018
• Actual Primary Completion Date: September 26, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT03696667
• Other Study ID Numbers: 2017/00297
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Institute of Mental Health, Singapore
• Original Responsible Party: Same as current
• Current Study Sponsor: Institute of Mental Health, Singapore
• Original Study Sponsor: Same as current

Collaborators

• Agency for Science, Technology and Research
• Duke-NUS Graduate Medical School

Investigators

• Principal Investigator: Jimmy Lee; Institute of Mental Health, Singapore

• PRS Account: Institute of Mental Health, Singapore
• Verification Date: September 2018