Amyotrophic Lateral Sclerosis
Conditions
Brief summary
People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer interface (BCI) keyboard to type in assistive technology devices. The results of this study will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.
Interventions
DEVICEP300 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.
Sponsors
U.S. Department of Education
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older. * Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities * Able to see the BCI display * Able to give informed consent * Able to understand and remember instructions concerning participation * Able to communicate effectively at least with familiar conversation partners
Exclusion criteria
* Are unable to give informed consent. * Are currently experiencing open head sores * Have a history of photo-sensitive epilepsy * Have a history of cognitive deficits requiring accommodation or special education services * Are unable to sit without moving the head and neck for at least 15 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Typing With a BCI Keyboard by ALS Patients. | 3 times over 2-4 weeks | 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 |
|---|---|
| P300 Brain Computer Interface for People With ALS P300 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | P300 Brain Computer Interface for People With ALS |
|---|---|
| Age, Continuous | 62 years |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Accuracy of Typing With a BCI Keyboard by ALS Patients.
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: 3 times over 2-4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brain-computer Interface (BCI) Environment | Accuracy of Typing With a BCI Keyboard by ALS Patients. | 81 percentage accuracy |
| Computer Environment | Accuracy of Typing With a BCI Keyboard by ALS Patients. | 78 percentage accuracy |
| Assistive Technology Enironment | Accuracy of Typing With a BCI Keyboard by ALS Patients. | 75 percentage accuracy |