P300 Brain Computer Interface Keyboard to Operate Assistive Technology

Phase 1

Completed

• Conditions: Neuromuscular Disease; Spinal Cord Injury; Cerebral Palsy; Healthy; Amyotrophic Lateral Sclerosis
• Interventions: Device: Brain Computer Interface Keyboard

• Registration Number: NCT00860951
• Lead Sponsor: University of Michigan

Brief Summary

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.

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-13
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-05
• Results First Submitted: 2015-05-27
• Results First Submitted QC: 2015-05-27
• Last Update Submitted: 2015-06-10
• Results First Posted: 2015-06-11
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brain Computer Interface Keyboard	Brain Computer Interface Keyboard	What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?

Primary Outcome Measures

Name	Time	Method
Accuracy of Typing With BCI Keyboard.	mean score from 3 sessions over 29 days	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.

Trial Locations

Locations (2)

Wadsworth Center; 🇺🇸 Albany, New York, United States

University of Michigan Direct Brain Interface Project; 🇺🇸 Ann Arbor, Michigan, United States