Mind-body Awareness Training and Brain-computer Interface

NCT03221374 | Completed Results DMC

• 1 other identifier: R01AT009263-01
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

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

Behavioral: Mindfulness Based Stress Reduction

Waitlist

NO INTERVENTION

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

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

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

Mindfulness Based Stress Reduction

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy volunteers
• Age 18-64, inclusive.
• Willing and able to provide written consent.
• Able to communicate in the English language.

You may not qualify if:

• 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

Sponsors & Collaborators

• Carnegie Mellon University: lead

Study Sites (1)

Biomedical Engineering Department Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Limitations of the MBSR brain-computer interface sub-study design: 1. The lack of an active control group that requires the same mental commitment of time or intensity as a meditation practice. 2. The exclusive use of the breath counting task as our sole measure of mindfulness. Limitation of the experienced meditation sub-study design: Due to the limited sample size, we were unable to determine if the difference in age and sex between groups were significantly influencing the results.

Results Point of Contact

• Title: Dr. Bin He
• Organization: Carnegie Mellon University

bhe1@andrew.cmu.edu

412-268-9857

Study Officials

• Bin He, Ph.D

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomedical Engineering

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 18, 2017
• Study Start: September 1, 2016
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-07

Locations

US (1)