An In-home Study of Brain Computer Interfaces
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|ClinicalTrials.gov Identifier: NCT01123200|
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Device: Brain Computer Interface for Wheelchair Tilt Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||An In-home Study of Brain Computer Interfaces|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
|Brain Computer Interface In-Home Use||
Device: 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.
- Duration of BCI Usage by Persons With ALS. [ Time Frame: Monthly measurements for a period of up to 18 months. ]Number of months of BCI usage by each participant.
- Changes in Accuracy of BCI for Controlling Devices and Text [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123200
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Jane Huggins, PhD||University of Michigan|