Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology

Healthy Clinical Trial

Official title:

Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01117727
• Other study ID #: I0003 - AT SMR Switch Control
• Secondary ID: 5R21HD054697
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 4, 2010
• Last updated: June 11, 2015
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: June 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2012
• Est. primary completion date: December 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 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

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Direct Brain Interface Project	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning	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. .	8 sessions over 2 months	No

External Links

•   University of Michigan Direct Brain Interface Project