Trial Outcomes & Findings for An In-home Study of Brain Computer Interfaces (NCT NCT01123200)

Results Overview

Number of months of BCI usage by each participant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Monthly measurements for a period of up to 18 months.

Results posted on

2017-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Brain Computer Interface In-Home Use Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Brain Computer Interface In-Home Use Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

An In-home Study of Brain Computer Interfaces

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brain Computer Interface In-Home Use n=1 Participants Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment 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	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Monthly measurements for a period of up to 18 months.

Number of months of BCI usage by each participant.

Outcome measures

Outcome measures
Measure	Brain Computer Interface In-Home Use n=1 Participants Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
Duration of BCI Usage by Persons With ALS.	5 months Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: 6 months, 12 months, 18 months

Population: The first six month period was not completed by any participant so accuracy data for six months could not be analyzed.

Changes in Accuracy Percentage (i.e., cumulative correct selections per month divided by the cumulative number of intended sections per month). Looking for trends over each 6 month period.

Outcome measures

Outcome data not reported

Adverse Events

Brain Computer Interface In-Home Use

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brain Computer Interface In-Home Use n=1 participants at risk Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
Product Issues Unexpected wheelchair movement	100.0% 1/1 • Number of events 1

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