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P300 Brain Computer Interface Keyboard to Operate Assistive Technology

Primary Purpose

Healthy, Amyotrophic Lateral Sclerosis, Neuromuscular Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brain Computer Interface Keyboard
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthy focused on measuring Normal

Eligibility Criteria

18 Years - undefined (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

  • University of Michigan Direct Brain Interface Project
  • Wadsworth Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Brain Computer Interface Keyboard

Arm Description

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

Outcomes

Primary Outcome Measures

Accuracy of Typing With BCI Keyboard.
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.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2009
Last Updated
June 10, 2015
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT00860951
Brief Title
P300 Brain Computer Interface Keyboard to Operate Assistive Technology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (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), U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to develop tools enable people who are paralyzed to operate technology and access computers. These tools are called brain computer interfaces (BCIs). BCIs would let a person use brain signals to operate technology.
Detailed Description
The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain computer interfaces (BCIs). BCIs would let a person use brain signals to operate technology. The investigators want to make a BCI that can be used to operate commercially available technologies for communication, environmental control or computer access. The BCI would replace a keyboard to let people operate these technologies without moving. However, the investigators need people to test the BCI so that the investigators can see how well it can replace a keyboard. The investigators want to understand how well it can work so that the investigators can make it useful for people who are paralyzed. The investigators will ask people to use the BCI to do things like make a communication system speak or type words on a computer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Amyotrophic Lateral Sclerosis, Neuromuscular Disease, Spinal Cord Injury, Cerebral Palsy
Keywords
Normal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain Computer Interface Keyboard
Arm Type
Other
Arm Description
What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?
Intervention Type
Device
Intervention Name(s)
Brain Computer Interface Keyboard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy of Typing With BCI Keyboard.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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
Facility Information:
Facility Name
University of Michigan Direct Brain Interface Project
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wadsworth Center
City
Albany
State/Province
New York
ZIP/Postal Code
12201
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.umich.edu/~umdbi/
Description
University of Michigan Direct Brain Interface Project

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P300 Brain Computer Interface Keyboard to Operate Assistive Technology

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