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An In-home Study of Brain Computer Interfaces

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01123200
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Amyotrophic Lateral Sclerosis
Intervention Device: Brain Computer Interface for Wheelchair Tilt Control
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brain Computer Interface In-Home Use
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Brain Computer Interface In-Home Use
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Duration of BCI Usage by Persons With ALS.
Hide Description Number of months of BCI usage by each participant.
Time Frame Monthly measurements for a period of up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brain Computer Interface In-Home Use
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1
Mean (Full Range)
Unit of Measure: months
5
(5 to 5)
2.Secondary Outcome
Title Changes in Accuracy of BCI for Controlling Devices and Text
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The first six month period was not completed by any participant so accuracy data for six months could not be analyzed.
Arm/Group Title Brain Computer Interface In-Home Use
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brain Computer Interface In-Home Use
Hide Arm/Group Description 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.
All-Cause Mortality
Brain Computer Interface In-Home Use
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Brain Computer Interface In-Home Use
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brain Computer Interface In-Home Use
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Product Issues   
Unexpected wheelchair movement * [1]  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
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.
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jane Huggins
Organization: University of Michigan
Phone: 734-936-7177
EMail: janeh@umich.edu
Layout table for additonal information
Responsible Party: Jane Huggins, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01123200    
Other Study ID Numbers: J0002
First Submitted: May 4, 2010
First Posted: May 14, 2010
Results First Submitted: January 12, 2017
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017