Mobility ImpairmentsNCT02011399
Brain Computer Interfaces (Mu Rhythm Learning)
An observational study of Mobility Impairments, run by University of Michigan at 1 site in United States.
Trial summary
Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. The Mu rhythm is a naturally occuring wave produced by the brain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Impairments
- What is being tested?
- Brain Computer Interface for Mu Rhythm
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Age 18 or older.
- Able to read text on a computer screen
- Able to understand and remember instructions concerning participation
Who cannot join
- Unable give informed consent.
- Unable to understand and follow instructions.
- Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
- Known to have photosensitive epilepsy.
- Open head lesions or sores
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EEG-based Brain Computer Interface and Mu Rhythm for Computer Access
Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals.
The Mu rhythm is a naturally occuring wave produced by the brain. This research project will determine how to best train subjects to use the Mu rhythm for computer control.
Read the detailed description
As a method of BCI control, Mu rhythms are difficult to learn and involve extensive training. The investigators want to keep users motivated and determine the best way to provide effective training. Healthy users will be trained to control a computer by wearing an electrode cap that is connected to a computer. They will have their levels of motivation and interest measured while learning to use the Mu rhythm. Two different types of learning programs will be used to determine which is most effective for Mu rhythm training. This method will be used for device control by people with severe physical impairments, who may be able to communicate or carry out other desired tasks using a BCI.
- Conditions
- Mobility Impairments
- Being tested
- Brain Computer Interface for Mu Rhythm
- Keywords
- brain, computer, interfaces, mobility impairments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Computer Interface for Mu RhythmProcedure or surgery
Also called The electrode cap used is made by Electro-cap International.
Device: Brain Computer Interface Subjects will wear an EEG (electrode) cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate a computer. Subjects will be asked to participate in 4-20 sessions.
Arms: Brain Computer Interface Keyboard
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Mu Rhythm Learning
The primary outcome measure is determining the best learning methods by which subjects can learn to use the Mu rhythm to hit targets on a computer screen.
Measured: 20 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Training procedure was not effective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility ImpairmentsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Huggins, PhD, University of Michigan
- Investigators
- Jane E. Huggins, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011399
- Sponsor's protocol ID
- I0001
- Status last verified
- Dec 2013
- First submitted
- 15 Apr 2011
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG-based Brain Computer Interface and Mu Rhythm for Computer Access
- ClinicalTrials.gov ID
- NCT02011399
- Acronym / sponsor ID
- I0001
- Conditions
- Mobility Impairments
- Keywords
- brain, computer, interfaces, mobility impairments
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Training procedure was not effective.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Dec 2013 (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.
Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals.
The Mu rhythm is a naturally occuring wave produced by the brain. This research project will determine how to best train subjects to use the Mu rhythm for computer control.
Detailed description
As a method of BCI control, Mu rhythms are difficult to learn and involve extensive training. The investigators want to keep users motivated and determine the best way to provide effective training. Healthy users will be trained to control a computer by wearing an electrode cap that is connected to a computer. They will have their levels of motivation and interest measured while learning to use the Mu rhythm. Two different types of learning programs will be used to determine which is most effective for Mu rhythm training. This method will be used for device control by people with severe physical impairments, who may be able to communicate or carry out other desired tasks using a BCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Age 18 or older.
- Able to read text on a computer screen
- Able to understand and remember instructions concerning participation
Key exclusion criteria (5 listed)
- Unable give informed consent.
- Unable to understand and follow instructions.
- Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
- Known to have photosensitive epilepsy.
- Open head lesions or sores
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Computer Interface for Mu RhythmAlso: The electrode cap used is made by Electro-cap International.Device: Brain Computer Interface Subjects will wear an EEG (electrode) cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate a computer. Subjects will be asked to participate in 4-20 sessions. Arms: Brain Computer Interface Keyboard | Procedure or surgery | – |
Primary outcome
Efficacy of Mu Rhythm Learning
Time frame: 20 sessions
The primary outcome measure is determining the best learning methods by which subjects can learn to use the Mu rhythm to hit targets on a computer screen.
Results and safety
The study was stopped early (reason given: Training procedure was not effective.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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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.
Jane E. Huggins, PhD principal investigator
University of Michigan
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 Mobility Impairments, run by University of Michigan 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Dec 2013. 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 was stopped early (reason given: Training procedure was not effective.). Results are not available in the source record.
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?
Efficacy of Mu Rhythm Learning (time frame: 20 sessions). 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 13 Dec 2013.