Trial Outcomes & Findings for P300 Brain Computer Interface Keyboard to Operate Assistive Technology (NCT NCT00860951)

NCT ID: NCT00860951

Last Updated: 2015-07-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: mean score from 3 sessions over 29 days
• Results posted on: 2015-07-09

Participant Flow

Participant milestones

Measure	Brain Computer Interface Keyboard What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard? 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.
Overall Study STARTED	29
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Brain Computer Interface Keyboard What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard? 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.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	5

Baseline Characteristics

P300 Brain Computer Interface Keyboard to Operate Assistive Technology

Baseline characteristics by cohort

Measure	Brain Computer Interface Keyboard n=22 Participants What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard? 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.
Age, Continuous	43 years n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	BCI Environment n=22 Participants Average accuracy of selections for three sessions of text copying within the BCI as a stand-alone device.	Computer Environment n=22 Participants Average accuracy of selections for three sessions of text copying within the BCI acting as a keyboard replacement for a laptop computer.	Assistive Technology Enironment n=22 Participants Average accuracy of selections for three sessions of text copying with the BCI acting as a keyboard replacement for a communication system.
Accuracy of Typing With BCI Keyboard.	85 percentage accuracy Interval 35.0 to 100.0	83 percentage accuracy Interval 27.0 to 100.0	83 percentage accuracy Interval 36.0 to 100.0

Adverse Events

Brain Computer Interface Keyboard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jane Huggins

University of Michigan

Phone: 734-936-7177

Email: janeh@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place