VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available

Available Documentation

Dates Data are Available

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Tamara.Paine@va.gov. Investigators may be asked to provide further documentation such as a study proposal. All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

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 

Time Period

September 2011 - August 2014

Setting

National

N

27 participants

Response Rate

Unconfirmed

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

Unconfirmed

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

A language activity monitor installed on the participants’ BCI systems was used to collect time-stamped logfiles as a record of language generated using the BCI systems. Data were transmitted from the BCI devices study centers for processing. Site personnel collected data from home visits on paper case report forms, which were entered into electronic data capture system.

Funding Source

VA Cooperative Studies Program (CSP)

Investigators

Study Chair: Robert Ruff, MD, PhD
Jonathan Wolpaw, MD
Richard Bedlack, Jr., MD, PhD

Contact

Tamara.Paine@va.gov

Selected Publications

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
• Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)