Amyotrophic Lateral Sclerosis, Healthy
Conditions
Keywords
Brain computer interface, wheelchair control
Brief summary
The investigators want to develop a brain-computer interface (BCI) that will eventually allow people who are completely paralyzed to independently control the tilt feature on their power wheelchairs. This study will allow healthy volunteers to test the feasibility and accuracy of controlling a BCI using only their brain signals while seated in a tilting wheelchair.
Interventions
DEVICEUsing a BCI to control wheelchair tilt
Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 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
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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 |
|---|---|---|
| The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. | 3 1-2 hour sessions over 2-4 weeks | Subjects will participate in 3 sessions. During each session each subject will copy a word in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days. |
Participant flow
Pre-assignment details
Of the 16 people consented, 2 were pilot subjects, not intended for inclusion in the final analysis. They helped to test the protocol and set-up for the planned data collection session to make sure that the instructions for future subjects were clear and that all equipment was working correctly.
Participants by arm
| Arm | Count |
|---|---|
| Tilt Testing Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Coughing caused unacceptable EEG quality | 1 |
| Overall Study | Didn't meet milestone criteria | 1 |
Baseline characteristics
| Characteristic | Tilt Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 40.5 years |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.
Subjects will participate in 3 sessions. During each session each subject will copy a word in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days.
Time frame: 3 1-2 hour sessions over 2-4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tilt Testing | The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. | BCI Controlled Movement | 91.18 % Accuracy of selections | Standard Deviation 6.36 |
| Tilt Testing | The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. | Continuous Movement | 88.38 % Accuracy of selections | Standard Deviation 11.69 |
| Tilt Testing | The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. | No Movement | 91.04 % Accuracy of selections | Standard Deviation 6.93 |