Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
Agency for Science, Technology and Research
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Institute of Mental Health, Singapore

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.

Condition or disease Intervention/treatment Phase
Emotion Regulation Device: BCI Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Singapore
Duke-NUS Medical School
Singapore, Singapore, 169857
Institute of Mental Health
Singapore, Singapore, 539747
Sponsors and Collaborators
Institute of Mental Health, Singapore
Agency for Science, Technology and Research
Duke-NUS Graduate Medical School
Investigators
Layout table for investigator information
Principal Investigator: Jimmy Lee Institute of Mental Health, Singapore

Layout table for additonal information
Responsible Party: Institute of Mental Health, Singapore
ClinicalTrials.gov Identifier: NCT03696667     History of Changes
Other Study ID Numbers: 2017/00297
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms