Healthy VolunteersNCT02169375
Sensorimotor Based Brain Computer Interface
A study testing Brain computer Interface Mu (SMR) rhythm in people with Healthy Volunteers, 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. Often, the computer software that analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals when the training target location is known. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Brain computer Interface Mu (SMR) rhythm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2011
- Phase
- Interventional
- 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
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: Effect of Normalizer Adaptation on Accuracy in a Sensorimotor Based Brain-Computer Interface
Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. Often, the computer software that analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals when the training target location is known. The investigators want the BCIs to be more universal, and not depend on knowing the target location. Therefore, the investigators will test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.
- Conditions
- Healthy Volunteers
- Being tested
- Brain computer Interface Mu (SMR) rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain computer Interface Mu (SMR) rhythmOther
Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 10 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mu Rhythm with adaptation | Experimental | Not described Receives: Other: Brain computer Interface Mu (SMR) rhythm |
| Mu Rhythm without adaptation | Experimental | Not described Receives: Other: Brain computer Interface Mu (SMR) rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of a mu rhythm BCI using adaptation versus no adaptation.
Accuracy with which subjects can select one of two targets after a 3-second time period. The accuracy for a run is calculated as the % of the trials in which the correct target is selected. The average accuracy will be calculated for each of the 10 usage sessions and changes over the sessions will be tracked.
Measured: 10 times over 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Insufficient improvement in primary measures under either condition.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jane Huggins, PhD, University of Michigan
- Investigators
- Jane Huggins, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169375
- Sponsor's protocol ID
- I0004
- Other IDs
- R21HD054913
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normalizer Adaptation on Accuracy in a Sensorimotor Based Brain-Computer Interface
- ClinicalTrials.gov ID
- NCT02169375
- Acronym / sponsor ID
- I0004
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient improvement in primary measures under either condition.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jun 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.
Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. Often, the computer software that analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals when the training target location is known. The investigators want the BCIs to be more universal, and not depend on knowing the target location. Therefore, the investigators will test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mu Rhythm with adaptation | Experimental | Other: Brain computer Interface Mu (SMR) rhythm |
| Mu Rhythm without adaptation | Experimental | Other: Brain computer Interface Mu (SMR) rhythm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 Mu (SMR) rhythmSubjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 10 sessions. | Other | Mu Rhythm with adaptation, Mu Rhythm without adaptation |
Primary outcome
Accuracy of a mu rhythm BCI using adaptation versus no adaptation.
Time frame: 10 times over 5 weeks
Accuracy with which subjects can select one of two targets after a 3-second time period. The accuracy for a run is calculated as the % of the trials in which the correct target is selected. The average accuracy will be calculated for each of the 10 usage sessions and changes over the sessions will be tracked.
Results and safety
The study was stopped early (reason given: Insufficient improvement in primary measures under either condition.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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 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?
A study testing Brain computer Interface Mu (SMR) rhythm in people with Healthy Volunteers, 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 23 Jun 2014. 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: Insufficient improvement in primary measures under either condition.). 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?
Accuracy of a mu rhythm BCI using adaptation versus no adaptation. (time frame: 10 times over 5 weeks). 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 23 Jun 2014.