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A P300 Brain Computer Interface to Operate Power Wheelchair Tilt

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ClinicalTrials.gov Identifier: NCT01123148
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : August 1, 2016
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
Conditions Healthy
Amyotrophic Lateral Sclerosis
Intervention Device: Using a BCI to control wheelchair tilt
Enrollment 16
Recruitment Details  
Pre-assignment Details Of the 16 people consented, 2 were pilot subjects, not intended for inclusion in the final analysis. They helped to test the protocol and set-up for the planned data collection session to make sure that the instructions for future subjects were clear and that all equipment was working correctly.
Arm/Group Title Tilt Testing
Hide Arm/Group Description Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
Period Title: Overall Study
Started 14
BCI Calibration >50% Accuracy 13
Completed 12
Not Completed 2
Reason Not Completed
Coughing caused unacceptable EEG quality             1
Didn't meet milestone criteria             1
Arm/Group Title Tilt Testing
Hide Arm/Group Description Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
40.5
(19 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
8
  66.7%
Male
4
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.
Hide Description Subjects will participate in 3 sessions. During each session each subject will copy a "word" in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days.
Time Frame 3 1-2 hour sessions over 2-4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tilt Testing
Hide Arm/Group Description:
Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: % Accuracy of selections
No Movement 91.04  (6.93)
BCI Controlled Movement 91.18  (6.36)
Continuous Movement 88.38  (11.69)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tilt Testing
Hide Arm/Group Description Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
All-Cause Mortality
Tilt Testing
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Tilt Testing
Affected / at Risk (%)
Total   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tilt Testing
Affected / at Risk (%)
Total   0/16 (0.00%) 
This study only includes data from able-bodied individuals.
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, PhD
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: NCT01123148    
Other Study ID Numbers: M0001
R21HD054913 ( U.S. NIH Grant/Contract )
First Submitted: May 4, 2010
First Posted: May 14, 2010
Results First Submitted: March 4, 2016
Results First Posted: August 1, 2016
Last Update Posted: August 1, 2016