Trial Outcomes & Findings for A P300 Brain Computer Interface to Operate Power Wheelchair Tilt (NCT NCT01123148)

Results Overview

Subjects will participate in 3 sessions. During each session each subject will copy a "word" in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

3 1-2 hour sessions over 2-4 weeks

Results posted on

2016-08-01

Participant Flow

Of the 16 people consented, 2 were pilot subjects, not intended for inclusion in the final analysis. They helped to test the protocol and set-up for the planned data collection session to make sure that the instructions for future subjects were clear and that all equipment was working correctly.

Participant milestones

Participant milestones
Measure	Tilt Testing Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
Overall Study STARTED	14
Overall Study BCI Calibration >50% Accuracy	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Tilt Testing Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
Overall Study Coughing caused unacceptable EEG quality	1
Overall Study Didn't meet milestone criteria	1

Baseline Characteristics

A P300 Brain Computer Interface to Operate Power Wheelchair Tilt

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tilt Testing n=12 Participants Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40.5 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 1-2 hour sessions over 2-4 weeks

Subjects will participate in 3 sessions. During each session each subject will copy a "word" in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days.

Outcome measures

Outcome measures
Measure	Tilt Testing n=12 Participants Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. No Movement	91.04 % Accuracy of selections Standard Deviation 6.93
The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. BCI Controlled Movement	91.18 % Accuracy of selections Standard Deviation 6.36
The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair. Continuous Movement	88.38 % Accuracy of selections Standard Deviation 11.69

Adverse Events

Tilt Testing

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, PhD

University of Michigan

Phone: 734-936-7177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place