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

NCT00786032 | Completed Results DMC

• 1 other identifier: 567
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Keywords

Amyotrophic Lateral Sclerosis; Brain Computer Interface (BCI); Lou Gehrig's disease

Outcome Measures

Primary Outcomes (4)

• BCI System Usage by the ALS Patient

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

  Up to 18 months

• BCI System Usage by the ALS Patient

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

  Up to 18 months

• BCI System Usage by the ALS Patient

  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.

  Up to 18 months

• BCI System Usage by the ALS Patient

  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.

  Up to 18 months

Secondary Outcomes (3)

• BCI Usage by and Impact on the ALS Patient

  Up to 18 months

• Time of BCI Impact on the Significant Other and Systems Operator

  Up to 18 months

• Facility Support Speed of Solution

  Up to 18 months

Study Arms (1)

BCI Device

All participants will use the BCI System as a means of communication.

Device: BCI Device

Interventions

BCI Device DEVICE

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.

Also known as: Brain Computer Interface Device (BCI)

BCI Device

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects were patients at five VA medical centers who were severely disabled by amyotrophic lateral sclerosis (ALS).

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• New York State Department of Health: collaborator

Study Sites (5)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

Albany VA Medical Center Samuel S. Stratton, Albany, NY

Albany, New York, 12208, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Some limitations would be the Caregivers willingness and ability to support BCI user. In addition, the caregivers limited availability and the time commitment of the usage of the BCI system.

Results Point of Contact

• Title: Project Manager
• Organization: Hines Coordinating Center

tamara.paine@va.gov

708-202-5785

Study Officials

• Robert Ruff, MD PhD

  VA Medical Center-Cleveland

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2014
• Last Updated: January 8, 2015
• Results First Posted: January 8, 2015

Record last verified: 2015-01

Locations

US (5)