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Completed

NCT Number: NCT03696667

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

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke-NUS Medical School, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCI

Device

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.

Primary outcomes

  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 outcomes

  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 outcomes

  1. Changes in functional MRI

    Time frame: Week 0 and Week 9

    To examine the neural mechanism underlying the intervention

Sponsors and collaborators

Lead sponsor

Institute of Mental Health, Singapore

Other

Collaborators

  • Agency for Science, Technology and Research
  • Duke-NUS Graduate Medical School

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2018
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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