Skip to content

Mind-body Awareness Training and Brain-computer Interface

Mind-body Awareness Training and Brain-computer Interface

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03221374
Enrollment
231
Registered
2017-07-18
Start date
2016-09-01
Completion date
2023-05-31
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices, has become increasingly prevalent due to an increase in awareness of the potential health benefits, and improvements in concentration that this training can provide to practitioners. In the present study, the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI) is being investigated. The hypothesis is that MBAT will improve performance in SMR based BCI.

Detailed description

In this protocol, the following hypothesis will be tested; namely that MBAT including the verified mindfulness based stress reduction (MBSR) course will improve the ability for subjects to concentrate on the control of the SMR thus improving the performance of BCI. Subjects will be recruited for short term MBAT and then undergo BCI training. The performance of subjects with MBAT will be compared with those without MBAT to test the hypothesis. Procedures involved include a standard 8-week MBSR course, and an EEG brain noninvasive brain computer interface study.

Interventions

BEHAVIORALMindfulness Based Stress Reduction

8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.

Sponsors

Carnegie Mellon University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Apparently healthy volunteers * Age 18-64, inclusive. * Willing and able to provide written consent. * Able to communicate in the English language.

Exclusion criteria

* Any past BCI experience. * Pregnancy * Any breathing, movement, or visual disorders. * Any active neurological or mental disorders. * History of epilepsy. * History of a vascular or cardiac disorder (e.g. heart disease) * History of a metabolic disorder (e.g. diabetes) * Any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.

Design outcomes

Primary

MeasureTime frameDescription
BCI Performance Change From Baseline6 months for each participant.This outcome is related to the sub-study to investigate the effect of the MBSR on BCI learning. During the course of the sub-study over approximately 6 months/cohort of participants, participant learning over time during the course of study will be examined in terms of performance change after the intervention as well as across sessions, with a positive number representing an increase, and a negative number to represent a decrease. The percent valid correct (percent correct over valid trials) metric will be used to evaluate learning.
Breath Counting Task6 months for each participant.This outcome is related to the sub-study to investigate the effect of the MBSR on BCI learning. The breath-counting task will be used to measure the participants' mindfulness. Specifically, participants will be asked to count their breaths in cycles of nine (inhale and exhale counting as one) for 18 minutes, pressing one button for the first eight breaths, and a second button for the ninth. Breath counting accuracy is quantified as the number of correctly labeled breath cycles divided by the total number of cycles. The breath-counting accuracy for pre and post-intervention will be used.
Survey Results and Correlation With BCI PerformanceDuring the first experiment session, when each participant did the screeningIn the first session, participants are asked to complete two surveys to measure one's level of mindfulness before the BCI experiment. In both surveys, a higher score indicates a higher level of mindfulness: Survey 1: The Freiburg Mindfulness Inventory (FMI), with 14 statements, such as I am open to the experience of the present moment. Participants are asked to use a 1-4 scale to indicate how often they have such an experience. The FMI score is calculated by summing up the answers to each question with a proper re-code of one question. FMI score range (minimum to maximum): 14 to 56. Survey 2: Day-to-Day Experiences, with 15 questions, such as I find it difficult to stay focused on what's happening in the present. Participants are asked to use a 1-6 scale to indicate how often they have such an experience. The Mindful Attention Awareness Scale (MAAS) is calculated by averaging answers to each question in this survey. MAAS score range (minimum to maximum): 1 to 6.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited by flyers posted around the campus, references by the meditator instructors, or department emails.

Pre-assignment details

Subjects will be excluded, if they tell the experimenter that they do not wish to continue the participation.

Participants by arm

ArmCount
Mindfulness Based Stress Reduction - UMN
Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.
72
Waitlist - UMN
Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing.
72
Experienced Meditator - CMU
participants that have more than 1 year of regular meditation experience
32
Meditation Naive - CMU
Participants that have no regular meditation experience
34
Mindfulness Based Stress Reduction - CMU
Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.
8
Waitlist - CMU
Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing.
8
Short Term Meditation - CMU - Meditation
Participants will undergo a 20-minute meditation between two Brain-computer interface sessions.
3
Short Term Meditation - CMU - Control
Participants will listen to a 20-min reading of meditation related journal aritcle between two Brain-computer interface sessions.
2
Total231

Baseline characteristics

CharacteristicMindfulness Based Stress Reduction - UMNWaitlist - UMNExperienced Meditator - CMUMeditation Naive - CMUMindfulness Based Stress Reduction - CMUWaitlist - CMUShort Term Meditation - CMU - MeditationShort Term Meditation - CMU - ControlTotal
Age, Continuous38.2 years
STANDARD_DEVIATION 14.6
34.1 years
STANDARD_DEVIATION 13.3
41.6 years
STANDARD_DEVIATION 16.5
26.5 years
STANDARD_DEVIATION 9.3
32.3 years
STANDARD_DEVIATION 15.4
26.8 years
STANDARD_DEVIATION 8
45.7 years
STANDARD_DEVIATION 19.3
39.5 years
STANDARD_DEVIATION 4.9
35.2 years
STANDARD_DEVIATION 14.4
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants1 Participants0 Participants2 Participants1 Participants0 Participants0 Participants0 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
63 Participants63 Participants30 Participants30 Participants7 Participants8 Participants3 Participants2 Participants206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
7 Participants8 Participants2 Participants2 Participants0 Participants0 Participants0 Participants0 Participants19 Participants
Prior regular meditation experience over 1 year0 Participants0 Participants32 Participants0 Participants0 Participants0 Participants1 Participants0 Participants33 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants7 Participants2 Participants5 Participants0 Participants6 Participants0 Participants0 Participants24 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants3 Participants4 Participants1 Participants2 Participants0 Participants1 Participants12 Participants
Race (NIH/OMB)
More than one race
7 Participants2 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants6 Participants2 Participants4 Participants1 Participants0 Participants0 Participants0 Participants17 Participants
Race (NIH/OMB)
White
57 Participants56 Participants24 Participants21 Participants6 Participants0 Participants3 Participants1 Participants168 Participants
Sex: Female, Male
Female
56 Participants59 Participants17 Participants23 Participants5 Participants2 Participants2 Participants0 Participants164 Participants
Sex: Female, Male
Male
16 Participants13 Participants15 Participants11 Participants3 Participants6 Participants1 Participants2 Participants67 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 720 / 720 / 320 / 340 / 80 / 80 / 30 / 2
other
Total, other adverse events
0 / 720 / 720 / 320 / 340 / 80 / 80 / 30 / 2
serious
Total, serious adverse events
0 / 720 / 720 / 320 / 340 / 80 / 80 / 30 / 2

Outcome results

Primary

BCI Performance Change From Baseline

This outcome is related to the sub-study to investigate the effect of the MBSR on BCI learning. During the course of the sub-study over approximately 6 months/cohort of participants, participant learning over time during the course of study will be examined in terms of performance change after the intervention as well as across sessions, with a positive number representing an increase, and a negative number to represent a decrease. The percent valid correct (percent correct over valid trials) metric will be used to evaluate learning.

Time frame: 6 months for each participant.

Population: The population consists of participants recruited in the UMN site to investigate the effect of 8-week MBSR class on the effect of BCI learning. During the analysis, participants were excluded if they dropped the experiment, did not follow the task guideline, or exhibited ceiling performance.~The number of participants in the Mindfulness-Based Stress Reduction - CMU, Waitlist - CMU are too small to draw statistical conclusions and thus were not included.

ArmMeasureValue (MEAN)Dispersion
Mindfulness Based Stress Reduction - UMNBCI Performance Change From Baseline16.87 Percent valid correct (PVC)Standard Deviation 14.55
Waitlist - UMNBCI Performance Change From Baseline7.9 Percent valid correct (PVC)Standard Deviation 15.96
p-value: 0.003Mixed Models Analysis
p-value: 0.024t-test, 2 sided
Primary

Breath Counting Task

This outcome is related to the sub-study to investigate the effect of the MBSR on BCI learning. The breath-counting task will be used to measure the participants' mindfulness. Specifically, participants will be asked to count their breaths in cycles of nine (inhale and exhale counting as one) for 18 minutes, pressing one button for the first eight breaths, and a second button for the ninth. Breath counting accuracy is quantified as the number of correctly labeled breath cycles divided by the total number of cycles. The breath-counting accuracy for pre and post-intervention will be used.

Time frame: 6 months for each participant.

Population: The population consists of participants recruited in the UMN site to investigate the effect of 8-week MBSR class on the effect of BCI learning. During the analysis, participants were excluded if they dropped the experiment, did not follow the task guideline, or exhibited ceiling performance.~The number of participants in the Mindfulness-Based Stress Reduction - CMU, Waitlist - CMU are too small to draw statistical conclusions and thus were not included.

ArmMeasureValue (MEDIAN)
Mindfulness Based Stress Reduction - UMNBreath Counting Task93.18 percentage of breath counting accuracy
Waitlist - UMNBreath Counting Task77.79 percentage of breath counting accuracy
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary

Survey Results and Correlation With BCI Performance

In the first session, participants are asked to complete two surveys to measure one's level of mindfulness before the BCI experiment. In both surveys, a higher score indicates a higher level of mindfulness: Survey 1: The Freiburg Mindfulness Inventory (FMI), with 14 statements, such as I am open to the experience of the present moment. Participants are asked to use a 1-4 scale to indicate how often they have such an experience. The FMI score is calculated by summing up the answers to each question with a proper re-code of one question. FMI score range (minimum to maximum): 14 to 56. Survey 2: Day-to-Day Experiences, with 15 questions, such as I find it difficult to stay focused on what's happening in the present. Participants are asked to use a 1-6 scale to indicate how often they have such an experience. The Mindful Attention Awareness Scale (MAAS) is calculated by averaging answers to each question in this survey. MAAS score range (minimum to maximum): 1 to 6.

Time frame: During the first experiment session, when each participant did the screening

Population: The population consists of experienced meditators and meditation naive controls. During the analysis, outliers whose BCI performance were outside the ± 2.5 median absolute deviations from the median of the whole sample were excluded.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Based Stress Reduction - UMNSurvey Results and Correlation With BCI PerformanceFMI score44.5 score on a scaleStandard Deviation 4.5
Mindfulness Based Stress Reduction - UMNSurvey Results and Correlation With BCI PerformanceMAAS score4.42 score on a scaleStandard Deviation 0.81
Waitlist - UMNSurvey Results and Correlation With BCI PerformanceFMI score36.6 score on a scaleStandard Deviation 6.7
Waitlist - UMNSurvey Results and Correlation With BCI PerformanceMAAS score3.73 score on a scaleStandard Deviation 0.67
p-value: <0.01Wilcoxon (Mann-Whitney)
p-value: <0.05Wilcoxon (Mann-Whitney)
p-value: <0.05Regression, Linear
p-value: <0.05Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026