Monday, June 30, 2025 6/30/2025

A Pilot Clinical Trial for Speech Neuroprosthesis

Award Number: U01DC018671
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/03/2021
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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A Pilot Clinical Trial for Speech Neuroprosthesis - PROJECT SUMMARY Neurological injury that results in the loss of communication is devastating. This proposed pilot trial is designed to evaluate the feasibility of speech prosthetic technology in a small cohort of paralyzed patients. We will leverage a decade-long scientific investigation of the functional properties of human speech motor cortex, and recent demonstration of speech decoding in normally speaking patients implanted with electrodes (for epilepsy surgery planning). We propose an early feasibility study of a long-term direct neural interface for restoration of communication. We propose three critical innovations to achieve this goal: 1) a chronically implanted high- density 128 channel electrocorticography (ECoG) array which samples from the entire lateral motor cortex (including speech motor cortex), 2) application of state-of-the-art neural network decoding approaches, and 3) direct comparison of text and speech synthesis decoder approaches. Electrocorticography is a method of recording neural activity (local field potentials) from the brain surface using non-penetrating electrodes. We hypothesize that ECoG may have distinct advantages for clinical application over current alternatives (e.g. microelectrode or scalp EEG) given that we can achieve both high-density sampling and cover the entire speech motor cortex. We have previously demonstrated that this scale and coverage is necessary and sufficient to decode speech in intact individuals. ECoG has an increasing well documented safety and reliability profile for long-term implantation in human medical applications such epilepsy and brain computer interfaces. We have already de-risked regulatory hurdles with FDA IDE and local IRB approval for investigational use. The primary goals of the study are to enable communication via text and synthesized speech decoded from neural signals. The secondary goal is to demonstrate the robustness and stability of ECoG-based recordings in the chronic implantation setting. These aims will determine the feasibility of speech neuroprosthetic technology in target population of patients who are paralyzed.


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: 2025 ( Subtotal = $1,085,087 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	002	5	6/13/2025	NON-COMPETING CONTINUATION	$108,507
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	001	5	2/24/2025	NON-COMPETING CONTINUATION	$976,580
2025	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	000	4	12/31/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,085,087

Issue Date FY: 2024 ( Subtotal = $878,875 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	001	4	2/14/2024	NON-COMPETING CONTINUATION	$770,079
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	002	4	5/3/2024	NON-COMPETING CONTINUATION	$108,796
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	000	3	12/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $878,875

Issue Date FY: 2023 ( Subtotal = $1,365,333 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	001	3	8/9/2023	NON-COMPETING CONTINUATION	$0
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	000	3	2/28/2023	NON-COMPETING CONTINUATION	$1,365,333
														Subtotal = $1,365,333

Issue Date FY: 2022 ( Subtotal = $1,093,507 )
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	002	2	7/15/2022	NON-COMPETING CONTINUATION	$0
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	001	2	5/24/2022	NON-COMPETING CONTINUATION	$0
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	000	2	5/11/2022	NON-COMPETING CONTINUATION	$1,093,507
														Subtotal = $1,093,507

Issue Date FY: 2021 ( Subtotal = $1,158,067 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Research Related to Deafness and Communication Disorders	000	1	3/4/2021	NEW	$1,158,067
														Subtotal = $1,158,067

Grand Total All Awards = $5,580,869

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A Pilot Clinical Trial for Speech Neuroprosthesis

Award Number: U01DC018671

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 03/03/2021

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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