Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology

NCT01117727 | Terminated Phase 1 Results

• 2 other identifiers: I0003 - AT SMR Switch Control5R21HD054697
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pilot Testing

EXPERIMENTAL

Device: Brain Computer Interface Switch

Interventions

Brain Computer Interface Switch DEVICE

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.

Pilot Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Able to read text on a computer screen
• Able to understand and remember instructions concerning participation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Michigan Direct Brain Interface Project

Ann Arbor, Michigan, 48108, United States

Location

Results Point of Contact

• Title: Jane Huggins
• Organization: University of Michigan

janeh@umich.edu

734-936-7177

Study Officials

• Jane Huggins, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 15, 2015
• Results First Posted: June 15, 2015

Record last verified: 2015-06

Locations

US (1)