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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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Healthy focused on measuring Brain computer interface, wheelchair control

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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)
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    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

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    A P300 Brain Computer Interface to Operate Power Wheelchair Tilt

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