A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01119001
First received: May 5, 2010
Last updated: June 10, 2015
Last verified: June 2015
Results First Received: May 27, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Amyotrophic Lateral Sclerosis
Intervention: Device: P300 Brain Computer Interface Keyboard

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
P300 Brain Computer Interface for People With ALS P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.

Participant Flow:   Overall Study
    P300 Brain Computer Interface for People With ALS  
STARTED     13  
COMPLETED     11  
NOT COMPLETED     2  
Withdrawal by Subject                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
P300 Brain Computer Interface for People With ALS P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.

Baseline Measures
    P300 Brain Computer Interface for People With ALS  
Number of Participants  
[units: participants]
  11  
Age  
[units: years]
Mean (Full Range)
  62   (45 to 78)  
Gender  
[units: participants]
 
Female     4  
Male     7  



  Outcome Measures

1.  Primary:   Accuracy of Typing With a BCI Keyboard by ALS Patients.   [ Time Frame: 3 times over 2-4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Jane Huggins
Organization: University of Michigan
phone: 734-936-7177
e-mail: janeh@umich.edu


Publications of Results:

Responsible Party: Jane Huggins, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01119001     History of Changes
Other Study ID Numbers: H0004
Study First Received: May 5, 2010
Results First Received: May 27, 2015
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board