Clinical trial NCT03221374: Mind-body Awareness Training and Brain-computer Interface
Official title: Mind-body Awareness Training and Brain-computer Interface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: BCI Performance Change From Baseline
timeFrame: 6 months for each participant.
measure: Breath Counting Task
timeFrame: 6 months for each participant.
measure: Survey Results and Correlation With BCI Performance
timeFrame: During the first experiment session, when each participant did the screening
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Biomedical Engineering Department Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Bin He, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: