N/A
N=27
A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients
ALS (Amyotrophic Lateral Sclerosis)
Bottom Line
View on ClinicalTrials.gov: NCT00786032 ↗Enrolled (actual)
27
Serious AEs
44.4%
Results posted
Jan 2015
Primary outcome: Primary: BCI System Usage by the ALS Patient — 171 days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- BCI Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BCI System Usage by the ALS Patient |
2.9 | — |
| PRIMARY BCI System Usage by the ALS Patient |
2.9 | — |
| PRIMARY BCI System Usage by the ALS Patient |
2.9 | — |
| PRIMARY BCI System Usage by the ALS Patient |
2.9 | — |
| SECONDARY BCI Usage by and Impact on the ALS Patient |
6.59; 7.75; 6.93; 6.52; 7.26 | — |
| SECONDARY Time of BCI Impact on the Significant Other and Systems Operator |
13; 15; 4 | — |
| SECONDARY Facility Support Speed of Solution |
62 | — |
Summary
The goal of this VA demonstration project is to show that the Brain-computer interface (BCI) technology is a clinically practical and important new communication and control option that can improve the lives of veterans with amyotrophic lateral sclerosis (ALS). The project will test four well-supported hypotheses: (1) that people with ALS who find (or will soon find) conventional assistive technology inadequate can and will use a BCI system for important purposes in their daily lives without close technical oversight, 2) they will continue and even increase this use throughout the period of the study, (3) that BCI use will improve their lives, and 4) BCI will improve the lives of their families and caregivers.
Eligibility Criteria
Inclusion and Exclusion Criteria
- Subject will be a veteran with El Escorial "Lab Supported Probable" or more definite diagnosis of ALS.
- Subject will have lost the ability to communicate either verbally or in writing (item 1 or item 4 on the ALS Functional Rating Scale-Revised (ALSFRS-R) score of 0, Appendix A) .
- Subject will be an adult (age >18).
- Subject will be living at home.
- Subject will be living within 100 miles of the participating study site.
- Subject will have corrected visual acuity of at least 20/80.
- Subject will have the ability to read and understand 6th grade English text on a computer screen.
- Subject will be able to indicate willingness and understanding of the consent form (using their existing method of communication).
- Subject will be able to identify one significant other.
- Subject will identify one system operator (person that agrees to be trained and set up the BCI). This person can be the significant other.
- Subject will be able to communicate non-verbally with their significant other, caregiver and system operator, and with study personnel.
- Significant other, caregiver and system operator will be able to indicate willingness and understanding of the consent form, be adults (age> 18) and expect to be with the subject for at least one year.
- Subject, significant other, caregiver and system operator will have life expectancy of at least one year.
- In the opinion of the BCI installation team, the home environment is physically and technologically conducive to BCI operation and use.
- Subject will demonstrate during the screening phase sufficient EEG interaction for the BCI to operate, i.e. classification rate of 70%. Classification rate is defined as 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.
- Significant other, caregiver and system operator will demonstrate during the screening phase sufficient skill to manage the daily set-up and routine operations needed for the subject's basic operation of the BCI.
Data sourced from ClinicalTrials.gov (NCT00786032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.