A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Primary Purpose
Healthy, Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Using a BCI to control wheelchair tilt
Sponsored by
About this trial
This is an interventional supportive care trial for Healthy focused on measuring Brain computer interface, wheelchair control
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tilt testing
Arm Description
Outcomes
Primary Outcome Measures
The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01123148
First Posted
May 4, 2010
Last Updated
June 20, 2016
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01123148
Brief Title
A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Official Title
A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Amyotrophic Lateral Sclerosis
Keywords
Brain computer interface, wheelchair control
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tilt testing
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Using a BCI to control wheelchair tilt
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Huggins, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://umich.edu/~umdbi
Description
University of Michigan Direct Brain Interface Project
Learn more about this trial
A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
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