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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Computer Interface In-Home Use | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Computer Interface for Wheelchair Tilt Control | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of BCI Usage by Persons With ALS. | Number of months of BCI usage by each participant. | Monthly measurements for a period of up to 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months, 12 months, 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Huggins, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of BCI Usage by Persons With ALS. | Number of months of BCI usage by each participant. | Posted | Mean | Full Range | months | Monthly measurements for a period of up to 18 months. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unexpected wheelchair movement | Product Issues | Non-systematic Assessment | After the BCI was shut down and disconnected, the wheelchair reportedly moved without the user operating the controls. The movement was brief and no injury occurred. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Huggins | University of Michigan | 734-936-7177 | janeh@umich.edu |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | The first six month period was not completed by any participant so accuracy data for six months could not be analyzed. | Posted | 6 months, 12 months, 18 months |
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| 0 |
| 1 |
| 1 |
| 1 |
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |