Mind-body Awareness Training and Brain-computer Interface

Carnegie Mellon University

Status: Completed

Conditions: Healthy Subjects

Treatments: Behavioral: Mindfulness Based Stress Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03221374

R01AT009263-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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231 participants in 2 patient groups

Mindfulness Based Stress Reduction

Experimental group

Description:

Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing.

Treatment:

Behavioral: Mindfulness Based Stress Reduction

Waitlist

No Intervention group

Description:

Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing.