Trial Outcomes & Findings for A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis (NCT NCT01119001)

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

NA

Target enrollment

13 participants

Primary outcome timeframe

3 times over 2-4 weeks

Results posted on

2015-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	P300 Brain Computer Interface for People With ALS P300 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	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	P300 Brain Computer Interface for People With ALS P300 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

Baseline Characteristics

A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	P300 Brain Computer Interface for People With ALS n=11 Participants P300 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	62 years n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants

PRIMARY outcome

Timeframe: 3 times over 2-4 weeks

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

Outcome measures
Measure	Brain-computer Interface (BCI) Environment n=11 Participants Accuracy typing for three sessions with the BCI acting as a stand-alone device.	Computer Environment n=11 Participants Accuracy typing for three sessions with the BCI acting as a keyboard for a laptop computer.	Assistive Technology Enironment n=11 Participants Accuracy typing for three sessions with the BCI acting as a keyboard for a Dynawrite communication system.
Accuracy of Typing With a BCI Keyboard by ALS Patients.	81 percentage accuracy Interval 41.0 to 100.0	78 percentage accuracy Interval 42.0 to 100.0	75 percentage accuracy Interval 25.0 to 100.0

Adverse Events

P300 Brain Computer Interface for People With ALS

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place