Amyotrophic Lateral Sclerosis, Cerebral Palsy, Healthy, Neuromuscular Disease, Spinal Cord Injury
Conditions
Keywords
Normal
Brief summary
The purpose of this research is to develop tools enable people who are paralyzed to operate technology and access computers. These tools are called brain computer interfaces (BCIs). BCIs would let a person use brain signals to operate technology.
Detailed description
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 let a person use brain signals to operate technology. 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 keyboard to let people operate these technologies without moving. However, the investigators need people to test the BCI so that the investigators can see how well it can replace a keyboard. The investigators want to understand how well it can work so that the investigators can make it useful for people who are paralyzed. The investigators will ask people to use the BCI to do things like make a communication system speak or type words on a computer.
Interventions
DEVICEBrain Computer Interface Keyboard
Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
U.S. Department of Education
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 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 Typing With BCI Keyboard. | mean score from 3 sessions over 29 days | Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character. Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brain Computer Interface Keyboard What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?
Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Brain Computer Interface Keyboard |
|---|---|
| Age, Continuous | 43 years |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Accuracy of Typing With BCI Keyboard.
Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character. Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.
Time frame: mean score from 3 sessions over 29 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BCI Environment | Accuracy of Typing With BCI Keyboard. | 85 percentage accuracy |
| Computer Environment | Accuracy of Typing With BCI Keyboard. | 83 percentage accuracy |
| Assistive Technology Enironment | Accuracy of Typing With BCI Keyboard. | 83 percentage accuracy |