P300 Brain Computer Interface Keyboard to Operate Assistive Technology

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Cerebral Palsy; Amyotrophic Lateral Sclerosis; Spinal Cord Injury; Neuromuscular Disease
• Intervention / Treatment: Device: Brain Computer Interface Keyboard

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Direct Brain Interface Project
  • New York
    • Albany, New York, United States, 12201
      • Wadsworth Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Brain Computer Interface Keyboard; What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); U.S. Department of Education

Publications and helpful links

Helpful Links

• University of Michigan Direct Brain Interface Project

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 11, 2009
• First Submitted That Met QC Criteria: March 11, 2009
• First Posted (Estimate): March 13, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: June 10, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Normal
• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Brain Damage, Chronic; Neurodegenerative Diseases; Trauma, Nervous System; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Cerebral Palsy; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Neuromuscular Diseases
• Other Study ID Numbers: H0002 - AT P300 Keyboard Study; 5R21HD054697 (U.S. NIH Grant/Contract); H133G090005 (Other Grant/Funding Number: Department of Education)