Back to resultsA P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P300 Brain Computer Interface Keyboard
Sponsored by
About this trial
This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older.
- Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities
- Able to see the BCI display
- Able to give informed consent
- Able to understand and remember instructions concerning participation
- Able to communicate effectively at least with familiar conversation partners
Exclusion Criteria:
- Are unable to give informed consent.
- Are currently experiencing open head sores
- Have a history of photo-sensitive epilepsy
- Have a history of cognitive deficits requiring accommodation or special education services
- Are unable to sit without moving the head and neck for at least 15 minutes
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
P300 Brain Computer Interface for people with ALS
Arm Description
Outcomes
Primary Outcome Measures
Accuracy of Typing With a BCI Keyboard by ALS Patients.
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
NCT ID
NCT01119001
First Posted
May 5, 2010
Last Updated
June 10, 2015
Sponsor
University of Michigan
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT01119001
Brief Title
A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis
Official Title
A P300 Brain Computer Interface Keyboard to Control Assistive Technology for People With Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 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
U.S. Department of Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer interface (BCI) keyboard to type in assistive technology devices. The results of this study will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
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
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P300 Brain Computer Interface for people with ALS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
P300 Brain Computer Interface Keyboard
Other Intervention Name(s)
Electrode cap made by Electro-cap International.
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 a BCI Keyboard by ALS Patients.
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
3 times over 2-4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older.
Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities
Able to see the BCI display
Able to give informed consent
Able to understand and remember instructions concerning participation
Able to communicate effectively at least with familiar conversation partners
Exclusion Criteria:
Are unable to give informed consent.
Are currently experiencing open head sores
Have a history of photo-sensitive epilepsy
Have a history of cognitive deficits requiring accommodation or special education services
Are unable to sit without moving the head and neck for at least 15 minutes
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
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23590556
Citation
Thompson DE, Gruis KL, Huggins JE. A plug-and-play brain-computer interface to operate commercial assistive technology. Disabil Rehabil Assist Technol. 2014 Mar;9(2):144-50. doi: 10.3109/17483107.2013.785036. Epub 2013 Apr 16.
Results Reference
result
Links:
URL
http://www.umich.edu/~umdbi/
Description
University of Michigan Direct Brain Interface Project
Learn more about this trial
A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis
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