Mind-body Awareness Training and Brain-computer Interface

Healthy Subjects Clinical Trial

Official title:

Mind-body Awareness Training and Brain-computer Interface

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221374
• Other study ID #: R01AT009263-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Behavioral:
• Mindfulness Based Stress Reduction
8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.

Locations

Country	Name	City	State
United States	Biomedical Engineering Department Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Carnegie Mellon University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCI Learning over BCI sessions	During the course of the study over approximately 6 months/cohort of subjects (with approximately 10 projected cohorts), subject learning over time during the course of study will be examined in terms of performance change before/after the intervention as well as across sessions. The percent valid correct (percent correct over valid trials) metric will be used to evaluate learning.	6 months for each participant. The overall project will last for 5 years.
Secondary	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.