Trial Outcomes & Findings for A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients (NCT NCT00786032)

NCT ID: NCT00786032

Last Updated: 2015-01-08

Results Overview

This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by total time.

• Recruitment status: COMPLETED
• Target enrollment: 27 participants
• Primary outcome timeframe: Up to 18 months
• Results posted on: 2015-01-08

Participant Flow

The recruitment process was from 09/01/11 to 04/30/12. After the participants were identified they were sent a letter asking them to participate. After that screening began. The participating sites were Cleveland, Durham, West Haven, Albany, Providence.

Screening qualifications of baseline assessment. The participants had initial contact for interest, consent obtained, and determine electrical environment. If participant passed screening they were enrolled and had to complete training on the device.

Participant milestones

Measure	BCI Device All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
Overall Study STARTED	27
Overall Study Independent Users	14
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	BCI Device All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
Overall Study Death	4
Overall Study Withdrawal by Subject	14
Overall Study Did not complete in the timeframe	6

Baseline Characteristics

A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients

Baseline characteristics by cohort

Measure	BCI Device n=27 Participants All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
Age, Continuous	61.32 years STANDARD_DEVIATION 11.67 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants
ALS-Functional Rating Scale-R (ALSFRS)	15 units on a scale STANDARD_DEVIATION 13 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 months

This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by total time.

Outcome measures

Measure	BCI Device n=14 Participants All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
BCI System Usage by the ALS Patient	171 days Standard Deviation 12

PRIMARY outcome

Timeframe: Up to 18 months

This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by time per application.

Outcome measures

Measure	BCI Device n=14 Participants All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
BCI System Usage by the ALS Patient	63 percentage of BCI time Standard Deviation 20

PRIMARY outcome

Timeframe: Up to 18 months

This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by accuracy. Accuracy rate - The proportion of correct selections made during the daily calibration period of "copy spelling." Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g., THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The independent-use periods of the 14 independent users was totaled by days. Of these days, BCI use was not possible for days (i.e. hiatus days) due to hospitalization, illness, home construction, travel, or BCI system assistant (SA) absence. Over these days, copy-spelling accuracy was averaged.

Outcome measures

Measure	BCI Device n=14 Participants All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
BCI System Usage by the ALS Patient	71 percentage of days Standard Deviation 11

PRIMARY outcome

Timeframe: Up to 18 months

This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by selection rate. Accuracy rate - The proportion of correct selections made during the daily calibration period of "copy spelling." Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g, THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The number of selections/min for the BCI applications was averaged across users.

Outcome measures

Measure	BCI Device n=14 Participants All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
BCI System Usage by the ALS Patient	2.9 number of selection per minute Standard Deviation 1.3

SECONDARY outcome

Timeframe: Up to 18 months

At three-month intervals, BCI use will be summarized. On a daily basis the BCI will record the total of number of selections made in copy spelling mode. Copy spelling mode is used for system calibration. Participants are expected to indicate that the burden associated with BCI use is inconsequential to the benefit derived from using the BCI. This will be assessed by the McGill Quality of Life (MQOL) at each visit.

Outcome measures

Measure	BCI Device n=14 Participants All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
BCI Usage by and Impact on the ALS Patient Visit 8.0 (15 month)	7.26 units on a scale Standard Deviation 0.61
BCI Usage by and Impact on the ALS Patient Visit 4.0 (3 month)	6.59 units on a scale Standard Deviation 1.94
BCI Usage by and Impact on the ALS Patient Visit 5.0 (6 month)	7.75 units on a scale Standard Deviation 0.85
BCI Usage by and Impact on the ALS Patient Visit 6.0 (9 month)	6.93 units on a scale Standard Deviation 1.63
BCI Usage by and Impact on the ALS Patient Visit 7.0 (12 month)	6.52 units on a scale Standard Deviation 1.56

SECONDARY outcome

Timeframe: Up to 18 months

The quality of life of the significant other, caregiver and system operator will be measured using the Caregiver Burden Assessment at visits. At three month intervals, the significant other, caregiver and system operator will be asked to estimate how much time they spend on the following tasks per day in minutes: BCI System setup ( placing the electrode cap and initiating system operation), BCI System cleanup, and BCI System maintenance (removing cap).

Outcome measures

Measure	BCI Device n=14 Participants All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
Time of BCI Impact on the Significant Other and Systems Operator BCI System setup	13 minutes Standard Deviation 6
Time of BCI Impact on the Significant Other and Systems Operator BCI System cleanup	15 minutes Standard Deviation 9
Time of BCI Impact on the Significant Other and Systems Operator BCI System maintenance	4 minutes Standard Deviation 6

SECONDARY outcome

Timeframe: Up to 18 months

This study will look at how the technical problems of the BCI are supported by the facility through analyzing the speed of solution.

Outcome measures

Measure	BCI Device n=14 Participants All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
Facility Support Speed of Solution	62 hours Standard Deviation 90

Adverse Events

BCI Device

Serious events: 12 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	BCI Device n=27 participants at risk All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
Infections and infestations Pneumonia	11.1% 3/27 • Number of events 3 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
General disorders Medical device complication and disease progression.	7.4% 2/27 • Number of events 2 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
Injury, poisoning and procedural complications Fall or overdose	7.4% 2/27 • Number of events 2 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
Surgical and medical procedures Gastrointestinal tube insertion	7.4% 2/27 • Number of events 2 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
Respiratory, thoracic and mediastinal disorders Aspiration	3.7% 1/27 • Number of events 1 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
Gastrointestinal disorders Gastrointestinal hemorrhage	3.7% 1/27 • Number of events 1 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
Social circumstances Respite care	3.7% 1/27 • Number of events 1 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device

Other adverse events

Measure	BCI Device n=27 participants at risk All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
Injury, poisoning and procedural complications Fall or procedural complications	7.4% 2/27 • Number of events 3 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
Surgical and medical procedures Therapy cessation and gastrointestinal tube insertion	7.4% 2/27 • Number of events 2 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
General disorders Unevaluable event	3.7% 1/27 • Number of events 1 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
Skin and subcutaneous tissue disorders Skin disorder	3.7% 1/27 • Number of events 1 • Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months. An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device

Additional Information

Project Manager

Hines Coordinating Center

Phone: 708-202-5785

Email: tamara.paine@va.gov

Results disclosure agreements

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