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VA Cooperative Studies Program (CSP)

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CSP #567: Amytrophic Lateral Sclerosis-Brain Computer Interface (ALS-BCI)

 

Data Sharing Statement

What's available?

Pending

Available Documentation

Pending

Dates Data are Available

Pending

Access Criteria

Pending

Study Characteristics

Objectives

To show that 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)

Era of Service

All

Population

Patients from 5 VA medical centers who were severely disabled by ALS.  All participants were taught to use BCI System as a means of communication.

Study Design

Prospective cohort study

Time Period

September 2011 - August 2014

Setting

National

N

27

Response Rate

Pending

Recruitment Method

Participants were identified from the National Registry of Veterans with ALS and sent a letter asking them to participate.  After initial contact and consent was obtained, screening qualifications of baseline assessment was conducted.  Participants who passed screening were enrolled and had to complete training on the device.

Compensation

Pending

Data Collected

  • BCI usage by and impact on the ALS patient, continued use assessed by total time used, time per application, and accuracy rate
  • Quality of life of the significant other, caregiver, and system operator assessed by time spent per day on BCI system setup, cleanup and maintenance (McGill Quality of Life (MQOL) measure, Caregiver Burden Assessment)
  • Facility support assessed by how fast technical problems of the BCI are solved

Data Collection Methods

  • Language activity monitor installed on the participants’ BCI systems collected time-stamped logfiles as a record of language generated using the BCI systems
  • Site personnel collected data from home visits on paper case report forms 

Funding Source

VA Cooperative Studies Program (CSP)

Contact

Tamara.Paine@va.gov

Selected Publication

Hill K, Kovacs T, Shin S. Critical issues using brain-computer interfaces for augmentative and alternative communication. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S8-15.

Bedlack R, Ruff R, Reda D, Vaughan T, Shi H, Hill K, Ringer R, Banks P, Paine T, Wolpaw J. A clinical demonstration of an EEG brain-computer interface (BCI) for ALS patients (VA Cooperative Study #567): enrollment, retention, and adherence. Neurology. 2015 Apr;82(10):P4.086.1

More Information

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT00786032




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