Amyotrophic Lateral Sclerosis
Conditions
Brief summary
The investigators are developing a tool to help people who are severely paralyzed. This tool is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic devices. This study allows a person with ALS to communicate, control their wheelchair tilt and perform other tasks using a BCI, thus increasing their independence.
Detailed description
This small-scale study of the feasibility of a BCI to operate the tilt position of a power wheelchair was also designed to determine the conditions and support structures necessary for use of a BCI in the home. In this study, people with Amyotrophic Lateral Sclerosis (ALS) will have a BCI in their home. They will receive training in order to operate and maintain the BCI. The BCI will allow them to access at least one task of primary interest to them. Task may include communication, computer access, control of assistive technology, or control of wheelchair seat position. Data concerning the use of the BCI will be collected throughout the study. Custom installations will be made for each participant to connect to their wheelchair and provide communication options if needed. Each installation is expected to be a unique prototype because of the differing control requirements for the individual wheelchairs in use by the participants. We intended to enroll six participants, but were only able to enroll one.
Interventions
DEVICEBrain Computer Interface for Wheelchair Tilt Control
Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
Sponsors
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. * Presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months. * Able to see the BCI display * Able to understand and remember instructions concerning participation. * Live in an environment that can accommodate the wheelchair portable BCI host computer * Expected to live in the same physical environment for at least 6 months. * Has family and caregiver(s) who are supportive of participation in this research. * Has a primary caregiver who is technically capable, willing to learn the setup and operation of the BCI system, and likely to remain with the subject for at least 6 months. * Has been shown to be able to use a BCI (in an experimental session under another IRB, e.g. HUM 00012968). * Has a clear understanding of the shortcomings of the present state of BCI technology
Exclusion criteria
* Open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes. * Inability to communicate well enough to give informed consent. * History of photo-sensitive epilepsy * Known significant cognitive deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of BCI Usage by Persons With ALS. | Monthly measurements for a period of up to 18 months. | Number of months of BCI usage by each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Accuracy of BCI for Controlling Devices and Text | 6 months, 12 months, 18 months | Changes in Accuracy Percentage (i.e., cumulative correct selections per month divided by the cumulative number of intended sections per month). Looking for trends over each 6 month period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brain Computer Interface In-Home Use Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Brain Computer Interface In-Home Use |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Duration of BCI Usage by Persons With ALS.
Number of months of BCI usage by each participant.
Time frame: Monthly measurements for a period of up to 18 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brain Computer Interface In-Home Use | Duration of BCI Usage by Persons With ALS. | 5 months |
Secondary
Changes in Accuracy of BCI for Controlling Devices and Text
Changes in Accuracy Percentage (i.e., cumulative correct selections per month divided by the cumulative number of intended sections per month). Looking for trends over each 6 month period.
Time frame: 6 months, 12 months, 18 months
Population: The first six month period was not completed by any participant so accuracy data for six months could not be analyzed.