N/A
N=231
Mind-body Awareness Training and Brain-computer Interface
Healthy Subjects
Bottom Line
View on ClinicalTrials.gov: NCT03221374 ↗Enrolled (actual)
231
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: BCI Performance Change From Baseline — 16.87; 7.9 Percent valid correct (PVC) — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Based Stress Reduction (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Carnegie Mellon University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BCI Performance Change From Baseline |
16.87; 7.9 | 0.003 sig |
| PRIMARY Breath Counting Task |
93.18; 77.79 | <0.001 sig |
| PRIMARY Survey Results and Correlation With BCI Performance |
44.5; 36.6; 4.42; 3.73 | <0.01 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03221374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.