Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology

This study has been terminated.
(Performance of BCI switch insufficient in pilot testing.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01117727
First received: May 4, 2010
Last updated: June 16, 2014
Last verified: June 2014
  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 allow a person to use brain signals to operate technology. Specifically this project's goal is to design a BCI to operate a switch.


Condition Intervention Phase
Healthy
Device: Brain Computer Interface Switch
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Accuracy of using the BCI as a switch for scanning. [ Time Frame: 20 times over 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pilot Testing 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.

Detailed 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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117727

Locations
United States, Michigan
University of Michigan Direct Brain Interface Project
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jane Huggins, PhD University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: Jane Huggins, PhD, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01117727     History of Changes
Other Study ID Numbers: I0003 - AT SMR Switch Control, 5R21HD054697
Study First Received: May 4, 2010
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014