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P300 Brain Computer Interface Keyboard to Operate Assistive Technology

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ClinicalTrials.gov Identifier: NCT00860951
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : June 11, 2015
Last Update Posted : July 9, 2015
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
U.S. Department of Education
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Amyotrophic Lateral Sclerosis Neuromuscular Disease Spinal Cord Injury Cerebral Palsy Device: Brain Computer Interface Keyboard Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Arms and Interventions
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Arm Intervention/treatment
Brain Computer Interface Keyboard
What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?
 Device: Brain Computer Interface Keyboard
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.


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of Typing With BCI Keyboard. [ Time Frame: mean score from 3 sessions over 29 days ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860951


Locations
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United States, Michigan
University of Michigan Direct Brain Interface Project
Ann Arbor, Michigan, United States, 48109
United States, New York
Wadsworth Center
Albany, New York, United States, 12201
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
U.S. Department of Education
Investigators
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Principal Investigator: Jane Huggins, PhD University of Michigan
More Information
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Additional Information:

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Responsible Party: Jane Huggins, PhD, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00860951    
Other Study ID Numbers: H0002 - AT P300 Keyboard Study
5R21HD054697 ( U.S. NIH Grant/Contract )
H133G090005 ( Other Grant/Funding Number: Department of Education )
First Posted: March 13, 2009    Key Record Dates
Results First Posted: June 11, 2015
Last Update Posted: July 9, 2015
Last Verified: May 2015
Keywords provided by Jane Huggins, PhD, University of Michigan:
Normal
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurodegenerative Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases