Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03696667|
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Emotion Regulation||Device: BCI||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression|
|Actual Study Start Date :||March 8, 2018|
|Actual Primary Completion Date :||September 26, 2018|
|Actual Study Completion Date :||September 26, 2018|
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.
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.
- 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
- 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
- Changes in functional MRI [ Time Frame: Week 0 and Week 9 ]To examine the neural mechanism underlying the intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696667
|Duke-NUS Medical School|
|Singapore, Singapore, 169857|
|Institute of Mental Health|
|Singapore, Singapore, 539747|
|Principal Investigator:||Jimmy Lee||Institute of Mental Health, Singapore|