Healthy Subjects
Conditions
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
8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| BCI Performance Change From Baseline | 6 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 Task | 6 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 Performance | During the first experiment session, when each participant did the screening | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 231 |
Baseline characteristics
| Characteristic | Mindfulness Based Stress Reduction - UMN | Waitlist - UMN | Experienced Meditator - CMU | Meditation Naive - CMU | Mindfulness Based Stress Reduction - CMU | Waitlist - CMU | Short Term Meditation - CMU - Meditation | Short Term Meditation - CMU - Control | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.2 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 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 63 Participants | 30 Participants | 30 Participants | 7 Participants | 8 Participants | 3 Participants | 2 Participants | 206 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 8 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 19 Participants |
| Prior regular meditation experience over 1 year | 0 Participants | 0 Participants | 32 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 2 Participants | 5 Participants | 0 Participants | 6 Participants | 0 Participants | 0 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 17 Participants |
| Race (NIH/OMB) White | 57 Participants | 56 Participants | 24 Participants | 21 Participants | 6 Participants | 0 Participants | 3 Participants | 1 Participants | 168 Participants |
| Sex: Female, Male Female | 56 Participants | 59 Participants | 17 Participants | 23 Participants | 5 Participants | 2 Participants | 2 Participants | 0 Participants | 164 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 15 Participants | 11 Participants | 3 Participants | 6 Participants | 1 Participants | 2 Participants | 67 Participants |
Adverse events
| Event type | EG000 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 / 72 | 0 / 72 | 0 / 32 | 0 / 34 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 72 | 0 / 72 | 0 / 32 | 0 / 34 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 | 0 / 32 | 0 / 34 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 2 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Stress Reduction - UMN | BCI Performance Change From Baseline | 16.87 Percent valid correct (PVC) | Standard Deviation 14.55 |
| Waitlist - UMN | BCI Performance Change From Baseline | 7.9 Percent valid correct (PVC) | Standard Deviation 15.96 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mindfulness Based Stress Reduction - UMN | Breath Counting Task | 93.18 percentage of breath counting accuracy |
| Waitlist - UMN | Breath Counting Task | 77.79 percentage of breath counting accuracy |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction - UMN | Survey Results and Correlation With BCI Performance | FMI score | 44.5 score on a scale | Standard Deviation 4.5 |
| Mindfulness Based Stress Reduction - UMN | Survey Results and Correlation With BCI Performance | MAAS score | 4.42 score on a scale | Standard Deviation 0.81 |
| Waitlist - UMN | Survey Results and Correlation With BCI Performance | FMI score | 36.6 score on a scale | Standard Deviation 6.7 |
| Waitlist - UMN | Survey Results and Correlation With BCI Performance | MAAS score | 3.73 score on a scale | Standard Deviation 0.67 |