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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction

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.

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Biomedical Engineering Department Carnegie Mellon University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCI Performance Change From Baseline	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.	6 months for each participant.
Breath Counting Task	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.	6 months for each participant.
Survey Results and Correlation With BCI Performance	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.	During the first experiment session, when each participant did the screening

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.

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Investigators: Principal Investigator: Bin He, Ph.D, Carnegie Mellon University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: R01AT009263-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No