Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Metrics for Brain Controlled Communication: A comprehensive review of clinical outcome assessments for communication brain computer interfaces in amyotrophic lateral sclerosis

Award Number: UH2FD008137
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2025

Group Awards By:

View Award Description

Metrics for Brain Controlled Communication: A comprehensive review of clinical outcome assessments for communication brain computer interfaces in amyotrophic lateral sclerosis - PROJECT SUMMARY/ABSTRACT Approximately 25,000 individuals in the US are currently living with amyotrophic lateral sclerosis (ALS), an ultimately fatal neurodegenerative disease that progressively impacts motor function. Patients may live for years after the onset of symptoms that result in complete loss of written and verbal communication, which drastically decreases quality of life, increases caregiver burden, and creates a significant barrier to life extending care and ALS research efforts. Communication brain computer interfaces (cBCIs) offer a unique opportunity for completely movement-free communication for those with severe paralysis due to ALS or other causes. Prior work with Blackrock Neurotech cBCI technology has developed methods to control keyboards, decode handwriting, restore speech, and restore verbal communication in locked-in ALS patients. In conjunction with development of our ground-breaking cBCI technologies, we hope to lead the market in the development of a comprehensive knowledgebase of how cBCIs affect ALS patients and how future advancements can better improve the lives of those with this irreversible, fatal condition. Our long-term goal is to establish and validate standardized clinical outcome assessments (COAs) to capture (1) the needs and values of ALS patients, their caregivers, and healthcare providers as they relate to communication and cBCIs, (2) patient perceptions of cBCIs, (3) capacity and efficacy of communication using cBCIs, (4) healthcare and quality of life impacts of cBCIs on patients and caregivers, and (5) financial and health economic impacts of cBCIs in the ALS population. Given the relative novelty of cBCIs as an option for ALS patients and the variation within and across cBCI technologies, there is a critical need to better understand how cBCIs are clinically assessed and to establish a framework for future development of COAs for cBCIs in patients with ALS. Our objective is to develop a deep and wide-ranging understanding of (1) the current clinical and scientific landscape surrounding cBCIs, (2) the assessment of their impacts and efficacy, (3) the strengths and weaknesses of current COAs, (4) patient needs and their perceptions of cBCIs, and (5) to evaluate areas for future COA development. UH2 development will comprise a comprehensive literature review and a series of interviews with key opinion leaders to establish a base of knowledge as well as expert perspectives on the current COA landscape related to cBCIs and the ALS patient population. UH3 development will occur in collaboration with Johns Hopkins University, Rancho Los Amigos National Rehabilitation Center, and the University of Utah and will consist of a series of patient and caregiver focus groups to gain insight into clinically meaningful concepts and endpoints related to communication and cBCI technologies. At the conclusion of this project, our expectation is that we will have comprehensively assessed the current landscape of COAs for cBCIs and identified a clear path toward future development of COAs to aid in clinical application and assessment of cBCIs to enhance the lives of those with advanced ALS.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	BLACKROCK MICROSYSTEMS, INC	630 S KOMAS DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Food and Drug Administration Research	000	1	10/16/2023	NEW	$0
2024	2023	BLACKROCK MICROSYSTEMS, INC	630 S KOMAS DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Food and Drug Administration Research	002	1	2/28/2024	NEW	$0
2024	2023	BLACKROCK MICROSYSTEMS, INC	630 S KOMAS DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Food and Drug Administration Research	001	1	12/12/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $199,809 )
2023	2023	BLACKROCK MICROSYSTEMS, INC	630 S KOMAS DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Food and Drug Administration Research	000	1	9/19/2023	NEW	$199,809
														Subtotal = $199,809

Grand Total All Awards = $199,809

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Metrics for Brain Controlled Communication: A comprehensive review of clinical outcome assessments for communication brain computer interfaces in amyotrophic lateral sclerosis

Award Number: UH2FD008137

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2025

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer