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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

Tracking Information
First Submitted Date  ICMJE May 4, 2010
First Posted Date  ICMJE May 14, 2010
Results First Submitted Date  ICMJE March 4, 2016
Results First Posted Date  ICMJE August 1, 2016
Last Update Posted Date August 1, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. [ Time Frame: 3 1-2 hour sessions over 2-4 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
The accuracy of BCI typing while tilting in a power wheelchair and while sitting still in a power wheelchair. [ Time Frame: 3 times over 2-4 weeks ]
Subjects will participate in 3 sessions. During each session each subject will copy a word by typing using only brainwaves. The accuracy of the subject's copy spelling of the designated word will be measured for each session.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Official Title  ICMJE A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Brief Summary The investigators want to develop a brain-computer interface (BCI) that will eventually allow people who are completely paralyzed to independently control the tilt feature on their power wheelchairs. This study will allow healthy volunteers to test the feasibility and accuracy of controlling a BCI using only their brain signals while seated in a tilting wheelchair.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Healthy
  • Amyotrophic Lateral Sclerosis
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Tilt testing
Intervention: Device: Using a BCI to control wheelchair tilt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2014)
16
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2010)
48
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 or older.
  • Able to read text on a computer screen
  • Able to understand and remember instructions concerning participation.

Exclusion Criteria:

  • Unable give informed consent.
  • Unable to understand and follow instructions.
  • Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
  • Known to have photosensitive epilepsy.
  • Open head lesions or sores.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01123148
Other Study ID Numbers  ICMJE M0001
R21HD054913 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jane Huggins, PhD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Jane Huggins, PhD University of Michigan
PRS Account University of Michigan
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP