Mind-body Awareness Training and Brain-computer Interface

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brain-Computer Interface and Mind-Body Awareness Training

NCT02074722

Healthy Subjects

COMPLETED

Development of Web-Based Mind-Body Trainings for Adults With Subjective Concerns

NCT06410807

Aging Focus Groups

COMPLETED

Internet-based Mind-Body Training for Brain Health

NCT07019402

Subjective Cognitive Decline

RECRUITING NA

Virtual Coach for Mindfulness Meditation Training

NCT01212497

Mindfulness Training

COMPLETED NA

The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury

NCT01613872

Traumatic Brain Injury Brain Injury Stress

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness Based Stress Reduction

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

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type BEHAVIORAL

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

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness Based Stress Reduction

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes