ClinicalTrials.gov

History of Changes for Study: NCT03696667
Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
Latest version (submitted October 3, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 October 3, 2018 None (earliest Version on record)
Comparison Format:

Scroll up to access the controls

Study NCT03696667
Submitted Date:  October 3, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2017/00297
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2018
Overall Status: Completed
Study Start: March 8, 2018
Primary Completion: September 26, 2018 [Actual]
Study Completion: September 26, 2018 [Actual]
First Submitted: October 3, 2018
First Submitted that
Met QC Criteria:
October 3, 2018
First Posted: October 5, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 3, 2018
Last Update Posted: October 5, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Institute of Mental Health, Singapore
Responsible Party: Sponsor
Collaborators: Agency for Science, Technology and Research
Duke-NUS Graduate Medical School
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Emotion Regulation
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Device Feasibility
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 30 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Emotion regulation questionnaire (ERQ)
[ Time Frame: Week 0 and Week 9 ]

To evaluate change in ERQ scores
2. Positive and Negative Affect Scale (PANAS)
[ Time Frame: Week 0 and Week 9 ]

To evaluate change in PANAS score
Secondary Outcome Measures:
1. Brief Assessment of Cognition - Short form
[ Time Frame: Week 0 and Week 9 ]

To evaluate changes in neurocognition
2. Geriatric Depression Scale (GDS)
[ Time Frame: Week 0 and Week 9 ]

To evaluate change in GDS score
3. Positive Mental Health (PMH) instrument
[ Time Frame: Week 0 and Week 9 ]

To evaluate change in PMH score
4. Body Awareness Questionnaire (BAQ)
[ Time Frame: Week 0 and Week 9 ]

To evaluate change in BAQ
5. Subjective Happiness Scale
[ Time Frame: Week 0 and Week 9 ]

To evaluate change in SHS
6. Connor-Davidson Resilience Scale 25 (CD-RISC-25)
[ Time Frame: Week 0 and Week 9 ]

To evaluate change in CD-RISC-25 score
7. The Frenchay Activities Index (FAI)
[ Time Frame: Week 0 and Week 9 ]

To evaluate change in FAI scores
8. Medical Outcomes Study: 20-item short form survey instrument
[ Time Frame: Week 0 and Week 9 ]

9. Outcome rating scale
[ Time Frame: After each BCI session during Weeks 1 to 8 ]

10. 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
Other Outcome Measures:
1. Changes in functional MRI
[ Time Frame: Week 0 and Week 9 ]

To examine the neural mechanism underlying the intervention
Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Study Officials: Jimmy Lee
Principal Investigator
Institute of Mental Health, Singapore
Locations: Singapore
Duke-NUS Medical School
Singapore, Singapore, 169857
Institute of Mental Health
Singapore, Singapore, 539747
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services