Healthy
Conditions
Brief summary
The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain-computer interfaces (BCIs). BCIs would allow a person to use brain signals to operate technology. Specifically this project's goal is to design a BCI to operate a switch.
Detailed description
The investigators want to make a BCI that can be used to operate commercially available technologies for communication, environmental control or computer access. The BCI would replace a switch to let people operate these technologies without moving. However, investigators need people to test the BCI so they can determine how effective it is in replacing a switch.
Interventions
DEVICEBrain Computer Interface Switch
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 14-20 sessions.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or older * Able to read text on a computer screen * Able to understand and remember instructions concerning participation
Exclusion criteria
* Unable to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning | 8 sessions over 2 months | Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. . |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pilot Testing Brain Computer Interface Switch: 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 14-20 sessions. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Pilot Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning
Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .
Time frame: 8 sessions over 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilot Testing, 0.65 Scan Rate | Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning | 60.5 percent of correct targets selected |
| Pilot Testing With Scan Rate at 2 Stdev | Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning | 78.4 percent of correct targets selected |