Emotion RegulationNCT03696667
Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
A study testing BCI in people with Emotion Regulation, run by Institute of Mental Health, Singapore at 2 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- BCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSingapore
- Study dates
- 8 Mar 2018to 26 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- Geriatric Depression Scale score of 4 and below
- Fit to provide informed consent
- Able to travel to study site independently
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Duke-NUS Medical School
Singapore, 169857
Institute of Mental Health
Singapore, 539747
About this study
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.
Read the 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.
- Conditions
- Emotion Regulation
- Being tested
- BCI
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCIDevice
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 group | Role | What they receive |
|---|---|---|
| Affective BCI training | Active comparator | 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. Receives: Device: BCI |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Emotion regulation questionnaire (ERQ)
To evaluate change in ERQ scores
Measured: Week 0 and Week 9
Positive and Negative Affect Scale (PANAS)
To evaluate change in PANAS score
Measured: Week 0 and Week 9
Secondary outcomes (10)
Brief Assessment of Cognition - Short form
To evaluate changes in neurocognition
Measured: Week 0 and Week 9
Geriatric Depression Scale (GDS)
To evaluate change in GDS score
Measured: Week 0 and Week 9
Positive Mental Health (PMH) instrument
To evaluate change in PMH score
Measured: Week 0 and Week 9
Body Awareness Questionnaire (BAQ)
To evaluate change in BAQ
Measured: Week 0 and Week 9
Subjective Happiness Scale
To evaluate change in SHS
Measured: Week 0 and Week 9
Connor-Davidson Resilience Scale 25 (CD-RISC-25)
To evaluate change in CD-RISC-25 score
Measured: Week 0 and Week 9
The Frenchay Activities Index (FAI)
To evaluate change in FAI scores
Measured: Week 0 and Week 9
Medical Outcomes Study: 20-item short form survey instrument
Measured: Week 0 and Week 9
Outcome rating scale
Measured: 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
Measured: At the end of Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start8 Mar 2018
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Jimmy Lee, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696667
- Sponsor's protocol ID
- 2017/00297
- Other IDs
- 2017
- Status last verified
- Sep 2018
- First submitted
- 3 Oct 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
- ClinicalTrials.gov ID
- NCT03696667
- Acronym / sponsor ID
- 2017/00297
- Conditions
- Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute of Mental Health, SingaporeUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research, Duke-NUS Graduate Medical School
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affective BCI training | Active comparator | Device: BCI15 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking
- Geriatric Depression Scale score of 4 and below
- Fit to provide informed consent
- Able to travel to study site independently
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCIAs 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. | Device | Affective BCI training |
Primary outcome
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
10 secondary outcomes
Brief Assessment of Cognition - Short form
Time frame: Week 0 and Week 9
Geriatric Depression Scale (GDS)
Time frame: Week 0 and Week 9
Positive Mental Health (PMH) instrument
Time frame: Week 0 and Week 9
Body Awareness Questionnaire (BAQ)
Time frame: Week 0 and Week 9
Subjective Happiness Scale
Time frame: Week 0 and Week 9
Connor-Davidson Resilience Scale 25 (CD-RISC-25)
Time frame: Week 0 and Week 9
The Frenchay Activities Index (FAI)
Time frame: Week 0 and Week 9
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Emotion Regulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy Lee principal investigator
Institute of Mental Health, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI in people with Emotion Regulation, run by Institute of Mental Health, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion regulation questionnaire (ERQ) (time frame: Week 0 and Week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.