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Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology

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ClinicalTrials.gov Identifier: NCT01117727
Recruitment Status : Terminated (Performance of BCI switch insufficient in pilot testing.)
First Posted : May 5, 2010
Results First Posted : June 15, 2015
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 allow a person to use brain signals to operate technology. Specifically this project's goal is to design a BCI to operate a switch.

Condition or disease Intervention/treatment Phase
Healthy Device: Brain Computer Interface Switch Phase 1 Phase 2

Detailed Description:
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 switch to let people operate these technologies without moving. However, investigators need people to test the BCI so they can determine how effective it is in replacing a switch.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology
Study Start Date : January 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pilot Testing Device: Brain Computer Interface Switch
Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.


Outcome Measures

Primary Outcome Measures :
  1. Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning [ Time Frame: 8 sessions over 2 months ]
    Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 to 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

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): NCT01117727


Locations
United States, Michigan
University of Michigan Direct Brain Interface Project
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jane Huggins, PhD University of Michigan
More Information

Additional Information:
Responsible Party: Jane Huggins, PhD, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01117727     History of Changes
Other Study ID Numbers: I0003 - AT SMR Switch Control
5R21HD054697 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2010    Key Record Dates
Results First Posted: June 15, 2015
Last Update Posted: June 15, 2015
Last Verified: June 2015