P300 Brain Computer Interface Keyboard to Operate Assistive Technology

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860951
• Other study ID #: H0002 - AT P300 Keyboard Study
• Secondary ID: 5R21HD054697H133
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 11, 2009
• Last updated: June 10, 2015
• Start date: September 2008
• Est. completion date: May 2012

Study information

• Verified date: May 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Cerebral Palsy
• Healthy
• Neuromuscular Disease
• Neuromuscular Diseases
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Wadsworth Center	Albany	New York
United States	University of Michigan Direct Brain Interface Project	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	mean score from 3 sessions over 29 days	No

External Links

•   University of Michigan Direct Brain Interface Project