P300 Brain Computer Interface Keyboard to Operate Assistive Technology

This study is ongoing, but not recruiting participants.

First Received: March 11, 2009 Last Updated: April 2, 2009 History of Changes

Sponsors and Collaborators:	University of Michigan Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00860951

Purpose

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.

Condition	Intervention	Phase
Healthy	Device: Brain Computer Interface Keyboard	Phase I Phase II

MedlinePlus related topics: Assistive Devices

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Single Group Assignment

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Accuracy of typing with BCI keyboard. [ Time Frame: 3 times over 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	158
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860951

Locations

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

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:

University of Michigan Direct Brain Interface Project This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Michigan Physical Medicine and Rehabilitation ( Jane Huggins, PhD/Research Assistant Professor )
Study ID Numbers:	H002 - AT P300 Keyboard Study
Study First Received:	March 11, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00860951 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Normal

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009