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P300 Brain Computer Interface Keyboard to Operate Assistive Technology

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ClinicalTrials.gov Identifier: NCT00860951
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : June 11, 2015
Last Update Posted : July 9, 2015
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
U.S. Department of Education
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Healthy
Amyotrophic Lateral Sclerosis
Neuromuscular Disease
Spinal Cord Injury
Cerebral Palsy
Intervention Device: Brain Computer Interface Keyboard
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brain Computer Interface Keyboard
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What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?

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.

Period Title: Overall Study
Started 29
Completed 22
Not Completed 7
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             5
Arm/Group Title Brain Computer Interface Keyboard
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What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?

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.

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
Participants who completed the protocol.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
43
(18 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
9
  40.9%
Male
13
  59.1%
1.Primary Outcome
Title Accuracy of Typing With BCI Keyboard.
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Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.

Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.

Time Frame mean score from 3 sessions over 29 days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCI Environment Computer Environment Assistive Technology Enironment
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Average accuracy of selections for three sessions of text copying within the BCI as a stand-alone device.
Average accuracy of selections for three sessions of text copying within the BCI acting as a keyboard replacement for a laptop computer.
Average accuracy of selections for three sessions of text copying with the BCI acting as a keyboard replacement for a communication system.
Overall Number of Participants Analyzed 22 22 22
Mean (Full Range)
Unit of Measure: percentage accuracy
85
(35 to 100)
83
(27 to 100)
83
(36 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brain Computer Interface Keyboard
Hide Arm/Group Description

What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?

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.

All-Cause Mortality
Brain Computer Interface Keyboard
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brain Computer Interface Keyboard
Affected / at Risk (%)
Total   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brain Computer Interface Keyboard
Affected / at Risk (%)
Total   0/29 (0.00%) 
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: NCT00860951     History of Changes
Other Study ID Numbers: H0002 - AT P300 Keyboard Study
5R21HD054697 ( U.S. NIH Grant/Contract )
H133G090005 ( Other Grant/Funding Number: Department of Education )
First Submitted: March 11, 2009
First Posted: March 13, 2009
Results First Submitted: May 27, 2015
Results First Posted: June 11, 2015
Last Update Posted: July 9, 2015