Healthy SubjectsNCT02074722
Brain-Computer Interface and Mind-Body Awareness Training
An observational study of Healthy Subjects, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 28 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy population in Minneapolis area
Who may be able to join
- 18-64 years old healthy subjects
Who cannot join
- History of traumatic brain injury/brain lesion, history of neurological deficit or neurodegenerative disorder, or history of epileptic seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nils Hasselmo Hall at the University of Minnesota - Twin Cities Campus
Minneapolis, Minnesota, 55455
About this study
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, we investigate the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).
The PI's hypothesis is that MBAT will improve performance in SMR based BCI.
Read the detailed description
In this protocol, we will test the PI's hypothesis that MBAT including yoga will improve the ability for subjects to concentrate on control 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 6 weeks yoga classes with at least 3 classes per week, and a EEG brain noninvasive brain computer interface study.
- Conditions
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Healthy Subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance over BCI sessions
During the course of the study over 5-10 weeks, we will quantitatively examine three main components of data: the proportion of subjects that achieve a pre-determined threshold of one-dimensional BCI competency as a time to event analysis, how subjects performed on average in each metric (accuracy, speed, etc.) over the course of the study (5-10 weeks), and subject learning over time during the course of study (5-10 weeks).
Measured: one to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin He, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074722
- Sponsor's protocol ID
- 1312M46727
- Status last verified
- Jan 2018
- First submitted
- 7 Feb 2014
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-Computer Interface and Mind-Body Awareness Training
- ClinicalTrials.gov ID
- NCT02074722
- Acronym / sponsor ID
- 1312M46727
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, we investigate the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).
The PI's hypothesis is that MBAT will improve performance in SMR based BCI.
Detailed description
In this protocol, we will test the PI's hypothesis that MBAT including yoga will improve the ability for subjects to concentrate on control 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 6 weeks yoga classes with at least 3 classes per week, and a EEG brain noninvasive brain computer interface study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | –Healthy Subjects |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy population in Minneapolis area
Key inclusion criteria (1 listed)
- 18-64 years old healthy subjects
Key exclusion criteria (1 listed)
- History of traumatic brain injury/brain lesion, history of neurological deficit or neurodegenerative disorder, or history of epileptic seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance over BCI sessions
Time frame: one to three months
During the course of the study over 5-10 weeks, we will quantitatively examine three main components of data: the proportion of subjects that achieve a pre-determined threshold of one-dimensional BCI competency as a time to event analysis, how subjects performed on average in each metric (accuracy, speed, etc.) over the course of the study (5-10 weeks), and subject learning over time during the course of study (5-10 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin He, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance over BCI sessions (time frame: one to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.