HealthyNCT02069938
Brain Computer Interface Control of a Robotic Device
An observational study of Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Noninvasive Brain-Computer Interfaces (BCIs) have been used to control a number of virtual and physical objects through the voluntary modulation of brain rhythms. Current issues with noninvasive BCIs include exhausting motor imagery tasks and long training times required to achieve competent control. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 13 Mar 2016
- 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 subjects, primarily from individuals on the University of Minnesota Campus and Minneapolis area
Who may be able to join
- Subjects for this study will be healthy, English speaking adult volunteers (18-64 years old).
Who cannot join
- History of neurological deficit or traumatic brain injury.
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
Noninvasive Brain-Computer Interfaces (BCIs) have been used to control a number of virtual and physical objects through the voluntary modulation of brain rhythms. Current issues with noninvasive BCIs include exhausting motor imagery tasks and long training times required to achieve competent control. The investigators will address these issues within this protocol, examining new approaches to reduce the effort required by subjects to control a physical object in the task.
The PI's hypothesis is: Control of a physical robotic device will increase the performance of subjects in BCI tasks that are analogous to virtual tasks due to greater engagement with a physical output.
Read the detailed description
Subjects will be recruited to participate in controlling a physical robotic device such as a quadcopter or a robotic arm using imagination of movement or other activities as detected by brain waves that can be used to control a robotic device.
The subjects will be able to observe the controlling of a robotics device using one's thought and participate in multiple sessions to learn the skills to better control such a device.
- Conditions
- Healthy
- Keywords
- 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 | Noninvasive Brain Computer Interface Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of trials correct within each session of Brain Computer Interface experiments.
Accuracy and performance metrics of Brain-Computer Interface tasks over time. This will include the percent of trials correct, percent of trials completed, and time to completion within each session. Combining these metrics, we will examine subject learning over sessions with regression. Exact time frame of sessions will be determined by subject and equipment availability.
Measured: Session 1 through 10, within an average of 5 weeks. Each session separated by at least 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startMar 2014
- Primary completion13 Mar 2016
- Study completion13 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 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
- NCT02069938
- Sponsor's protocol ID
- 1312M46742
- Status last verified
- Jan 2018
- First submitted
- 18 Feb 2014
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface Control of a Robotic Device
- ClinicalTrials.gov ID
- NCT02069938
- Acronym / sponsor ID
- 1312M46742
- Conditions
- Healthy
- Keywords
- Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 13 Mar 2016 (actual)
- Study completion
- 13 Mar 2016 (actual)
- First posted
- 24 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.
Noninvasive Brain-Computer Interfaces (BCIs) have been used to control a number of virtual and physical objects through the voluntary modulation of brain rhythms. Current issues with noninvasive BCIs include exhausting motor imagery tasks and long training times required to achieve competent control. The investigators will address these issues within this protocol, examining new approaches to reduce the effort required by subjects to control a physical object in the task.
The PI's hypothesis is: Control of a physical robotic device will increase the performance of subjects in BCI tasks that are analogous to virtual tasks due to greater engagement with a physical output.
Detailed description
Subjects will be recruited to participate in controlling a physical robotic device such as a quadcopter or a robotic arm using imagination of movement or other activities as detected by brain waves that can be used to control a robotic device.
The subjects will be able to observe the controlling of a robotics device using one's thought and participate in multiple sessions to learn the skills to better control such a device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | –Noninvasive Brain Computer Interface Control |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects, primarily from individuals on the University of Minnesota Campus and Minneapolis area
Key inclusion criteria (1 listed)
- Subjects for this study will be healthy, English speaking adult volunteers (18-64 years old).
Key exclusion criteria (1 listed)
- History of neurological deficit or traumatic brain injury.
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
Percent of trials correct within each session of Brain Computer Interface experiments.
Time frame: Session 1 through 10, within an average of 5 weeks. Each session separated by at least 24 hours.
Accuracy and performance metrics of Brain-Computer Interface tasks over time. This will include the percent of trials correct, percent of trials completed, and time to completion within each session. Combining these metrics, we will examine subject learning over sessions with regression. Exact time frame of sessions will be determined by subject and equipment availability.
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 18 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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, 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 18 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?
Percent of trials correct within each session of Brain Computer Interface experiments. (time frame: Session 1 through 10, within an average of 5 weeks. Each session separated by at least 24 hours.). 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 18 Jan 2018.