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

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ClinicalTrials.gov Identifier: NCT03696667
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
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  ICMJE October 3, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE March 8, 2018
Actual Primary Completion Date September 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Emotion Regulation
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2018)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 26, 2018
Actual Primary Completion Date September 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03696667
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Institute of Mental Health, Singapore
Study Sponsor  ICMJE Institute of Mental Health, Singapore
Collaborators  ICMJE
  • Agency for Science, Technology and Research
  • Duke-NUS Graduate Medical School
Investigators  ICMJE
Principal Investigator: Jimmy Lee Institute of Mental Health, Singapore
PRS Account Institute of Mental Health, Singapore
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP