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Completed

NCT Number: NCT03221374

Mind-body Awareness Training and Brain-computer Interface

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomedical Engineering Department Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

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

Primary outcomes

  1. BCI Performance Change From Baseline

    Time frame: 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.

  2. Breath Counting Task

    Time frame: 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.

  3. Survey Results and Correlation With BCI Performance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2017
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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