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

Emotion Regulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696667
• Other study ID #: 2017/00297
• Status: Completed
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: September 26, 2018

Study information

• Verified date: September 2018
• Source: Institute of Mental Health, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• 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.

Locations

Country	Name	City	State
Singapore	Duke-NUS Medical School	Singapore
Singapore	Institute of Mental Health	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Mental Health, Singapore	Agency for Science, Technology and Research, Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in functional MRI	To examine the neural mechanism underlying the intervention	Week 0 and Week 9
Primary	Emotion regulation questionnaire (ERQ)	To evaluate change in ERQ scores	Week 0 and Week 9
Primary	Positive and Negative Affect Scale (PANAS)	To evaluate change in PANAS score	Week 0 and Week 9
Secondary	Brief Assessment of Cognition - Short form	To evaluate changes in neurocognition	Week 0 and Week 9
Secondary	Geriatric Depression Scale (GDS)	To evaluate change in GDS score	Week 0 and Week 9
Secondary	Positive Mental Health (PMH) instrument	To evaluate change in PMH score	Week 0 and Week 9
Secondary	Body Awareness Questionnaire (BAQ)	To evaluate change in BAQ	Week 0 and Week 9
Secondary	Subjective Happiness Scale	To evaluate change in SHS	Week 0 and Week 9
Secondary	Connor-Davidson Resilience Scale 25 (CD-RISC-25)	To evaluate change in CD-RISC-25 score	Week 0 and Week 9
Secondary	The Frenchay Activities Index (FAI)	To evaluate change in FAI scores	Week 0 and Week 9
Secondary	Medical Outcomes Study: 20-item short form survey instrument		Week 0 and Week 9
Secondary	Outcome rating scale		After each BCI session during Weeks 1 to 8
Secondary	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