Sensorimotor Based Brain Computer Interface

Healthy Volunteers Clinical Trial

Official title:

Effect of Normalizer Adaptation on Accuracy in a Sensorimotor Based Brain-Computer Interface

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02169375
• Other study ID #: I0004
• Secondary ID: R21HD054913
• Status: Terminated
• Phase: N/A
• First received: June 16, 2014
• Last updated: June 18, 2014
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. Often, the computer software that analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals when the training target location is known. The investigators want the BCIs to be more universal, and not depend on knowing the target location. Therefore, the investigators will test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Brain computer Interface Mu (SMR) rhythm
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 10 sessions.

Locations

Country	Name	City	State
United States	University of Michigan	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 a mu rhythm BCI using adaptation versus no adaptation.	Accuracy with which subjects can select one of two targets after a 3-second time period. The accuracy for a run is calculated as the % of the trials in which the correct target is selected. The average accuracy will be calculated for each of the 10 usage sessions and changes over the sessions will be tracked.	10 times over 5 weeks	No

External Links

•   University of Michigan Direct Brain Interface Project