Trial Outcomes & Findings for Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology (NCT NCT01117727)

Results Overview

Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

8 sessions over 2 months

Results posted on

2015-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Pilot Testing Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot Testing n=1 Participants Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 sessions over 2 months

Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .

Outcome measures

Outcome measures
Measure	Pilot Testing, 0.65 Scan Rate n=1 Participants Pilot subject testing protocol with scan rate at 0.65 seconds per item.	Pilot Testing With Scan Rate at 2 Stdev n=1 Participants Pilot testing with scan rate set at twice the standard deviation of the reaction time.
Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning	60.5 percent of correct targets selected	78.4 percent of correct targets selected

Adverse Events

Pilot 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

University of Michigan

Phone: 734-936-7177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place