Mind-body Awareness Training and Brain-computer Interface

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mind-body Awareness Training and Brain-computer Interface

Conditions
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Healthy Subjects

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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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. Exclusion criteria that would prevent subjects from participating in the optional MRI component will be: Any MRI incompatible indwelling metal objects or implantable devices, including but not limited to the following (dental mental is allowable): Cardiac pacemaker Implanted cardiac defibrillator Carotid artery vascular clamp Intravascular stents, filters, or coils Aortic clip Internal pacing wires Vascular access port and/or catheter Swan-Ganz catheter Shunt (spinal or intraventricular) Aneurysm clip(s) Neurostimulator Electrodes (on body, head, or brain) Heart valve prosthesis Any type of prosthesis (eye, penile, etc.) Artificial limb or joint replacement Bone growth/fusion stimulator Bone/joint pin, screw, nail, wire, plate Metal rods in bones Harrington rods (spine) Metal or wire mesh implants Wire sutures or surgical staples Insulin pump or infusion device Any metal fragments (i.e. metal shop) Any implant held in place by a magnet Cochlear, otologic, or ear implant Claustrophobia Hearing aid use Any yoga/meditation in the last three months. More than 12 yoga/meditation classes in the last 12 months. Approximately weekly yoga/meditation for a year or more at any point in the past.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Stress Reduction<br>Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. | Behavioral: Mindfulness Based Stress Reduction<br>* 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.<br>|
| No Intervention: Waitlist<br>Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCI Learning over BCI sessions | During the course of the study over approximately 6 months/cohort of subjects (with approximately 10 projected cohorts), subject learning over time during the course of study will be examined in terms of performance change before/after the intervention as well as across sessions. The percent valid correct (percent correct over valid trials) metric will be used to evaluate learning. | 6 months for each participant. The overall project will last for 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of proficient subjects | During the course of the study over approximately 6 months/cohort of subjects (with approximately 10 projected cohorts), the proportion of subjects that achieve a pre-determined threshold of one-dimensional BCI competency as a time to event analysis will be examined for each group. | 6 months for each participant. The overall project will last for 5 years. |