IndividualityNCT02071485
Non-Invasive Brain-Computer Interface for Virtual Object Control
An observational study of Individuality, run by University of Minnesota at 1 site in United States.
Trial summary
A brain-computer interface (BCI) is a system that provides a separate output pathway for neurological signals whereby they can be interpreted to determine the user's intended cognitive action. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Individuality
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 8 Jan 2018
- 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: Students and workers at the University of Minnesota - Twin Cities campus
Who may be able to join
- Between the age of 18 and 64
Who cannot join
- History of traumatic brain injury/brain lesion, neurological deficit or neurodegenerative disorder
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
A brain-computer interface (BCI) is a system that provides a separate output pathway for neurological signals whereby they can be interpreted to determine the user's intended cognitive action. Utilizing EEG-based sensorimotor rhythms (SMRs) generated in the motor cortex has allowed subjects to control virtual computer cursors in up to three dimensions by simply imagining the movement of a specified body part. Nevertheless, the scalp EEG signals are smeared by the volume conduction effect and measurement noise. The overall hypothesis of this study is that EEG-based virtual object control may help reveal optimal motor imagination tasks best used in a BCI.
The PI's hypotheses include: (1) The use of advanced signal processing techniques will better reveal characteristics of EEG signals that represent the underlying motor cognitive function of the subject; (2) BCI systems based on SMR generated using motor imaginations will allow effective control of a virtual object in real time; (3) EEG imaging techniques will provide insight into the areas of cortical activation during a motor imagery task that can be utilized to increase the spatial resolution of non-invasive BCI's.
Read the detailed description
The goal of the present study is to explore advanced signal processing techniques that will better reveal characteristics of EEG signals that represent the underlying motor cognitive function of the subject, and conduct experiments to better control an virtual object on the computer screen including a cursor or a helicopter.
The primary objective of this study is to test the above hypotheses (1) and (2) in a healthy subject population.This study will determine the ability of subjects with full cognitive function to control a non-invasive brain-computer interface by imagining a particular movement. Using non-invasive methods, we will investigate the neural processes that occur during the motor imagination tasks associated with controlling a virtual object. Using a variety of motor imaginations, we will determine which tasks are best used for BCI control by quantitative means of BCI performance and neurological dynamic system analysis.
Subjects for this study will be healthy, English speaking adult volunteers (18-64 years old) with no history of mental illness, neurological deficit, or traumatic brain injury.
- Conditions
- Individuality
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 |
|---|---|---|
| No treatment | Subjects in this study will receive no treatment and rather will only be trained in using the motor imagination-based BCI system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification accuracy (%) and Cohen's Kappa Coefficient (unit-less) will be measured by discriminating features within the EEG time courses of different motor imagery tasks.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startMar 2014
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IndividualityStudies 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
- 205 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
- NCT02071485
- Sponsor's protocol ID
- 1312M46726
- 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
- Non-Invasive Brain-Computer Interface for Virtual Object Control
- ClinicalTrials.gov ID
- NCT02071485
- Acronym / sponsor ID
- 1312M46726
- Conditions
- Individuality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 26 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.
A brain-computer interface (BCI) is a system that provides a separate output pathway for neurological signals whereby they can be interpreted to determine the user's intended cognitive action. Utilizing EEG-based sensorimotor rhythms (SMRs) generated in the motor cortex has allowed subjects to control virtual computer cursors in up to three dimensions by simply imagining the movement of a specified body part. Nevertheless, the scalp EEG signals are smeared by the volume conduction effect and measurement noise. The overall hypothesis of this study is that EEG-based virtual object control may help reveal optimal motor imagination tasks best used in a BCI.
The PI's hypotheses include: (1) The use of advanced signal processing techniques will better reveal characteristics of EEG signals that represent the underlying motor cognitive function of the subject; (2) BCI systems based on SMR generated using motor imaginations will allow effective control of a virtual object in real time; (3) EEG imaging techniques will provide insight into the areas of cortical activation during a motor imagery task that can be utilized to increase the spatial resolution of non-invasive BCI's.
Detailed description
The goal of the present study is to explore advanced signal processing techniques that will better reveal characteristics of EEG signals that represent the underlying motor cognitive function of the subject, and conduct experiments to better control an virtual object on the computer screen including a cursor or a helicopter.
The primary objective of this study is to test the above hypotheses (1) and (2) in a healthy subject population.This study will determine the ability of subjects with full cognitive function to control a non-invasive brain-computer interface by imagining a particular movement. Using non-invasive methods, we will investigate the neural processes that occur during the motor imagination tasks associated with controlling a virtual object. Using a variety of motor imaginations, we will determine which tasks are best used for BCI control by quantitative means of BCI performance and neurological dynamic system analysis.
Subjects for this study will be healthy, English speaking adult volunteers (18-64 years old) with no history of mental illness, neurological deficit, or traumatic brain injury.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –Subjects in this study will receive no treatment and rather will only be trained in using the motor imagination-based BCI system |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students and workers at the University of Minnesota - Twin Cities campus
Key inclusion criteria (1 listed)
- Between the age of 18 and 64
Key exclusion criteria (1 listed)
- History of traumatic brain injury/brain lesion, neurological deficit or neurodegenerative disorder
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
Classification accuracy (%) and Cohen's Kappa Coefficient (unit-less) will be measured by discriminating features within the EEG time courses of different motor imagery tasks.
Time frame: two years
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 Individuality, 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?
Classification accuracy (%) and Cohen's Kappa Coefficient (unit-less) will be measured by discriminating features within the EEG time courses of different motor imagery tasks. (time frame: two years). 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.