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Development of a Miniaturized Wearable Ultrasonic Beam-forming Device for Localized Targeting of Brain Regions in Freely-moving Experimental Subjects

Award Number: R43NS126007
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Development of a Miniaturized Wearable Ultrasonic Beam-forming Device for Localized Targeting of Brain Regions in Freely-moving Experimental Subjects - This Phase I SBIR will further develop, validate, and initiate commercialization of the miniature ultrasound beamforming array (MUBA) system for transcranial focused ultrasound (tFUS). The MUBA system will allow preclinical researchers to reversibly and non-invasively modulate neural activity in intact brain circuits with unparalleled precision. The technology was first developed under a BRAIN initiative-funded exploratory research grant (5R21EY029424; PI: Dr. Kiani). We will ready this system for commercialization for preclinical research applications in response to ‘Translation of BRAIN Initiative Technologies to the Marketplace’ (NOT- MH-21-125) under BRAIN initiative priority area #4: ‘Interventional Tools: link brain activity to behavior with precise interventional tools that change neural circuit dynamics.’ Public Health Problem: The therapeutic utility of brain stimulation, or more generally neuromodulation, in managing numerous neurological and psychiatric diseases is well understood. Deep brain stimulation (DBS) ameliorates Parkinson’s disease symptoms and is being examined for neurological conditions such as dystonia, epilepsy, depression, and obsessive-compulsive disorder. Neuromodulation is also a powerful tool to study brain circuits by being able to selectively activate/inactivate regions (e.g. optogenetics, sonothermogenetics). Currently, neuromodulation can be achieved with different modalities from pharmacological and chemical methods, which lack specificity and have numerous metabolic requirements, to physical methods such as electrical, electromagnetic, optical, and ultrasound. Among noninvasive methods, low-intensity transcranial focused ultrasound (tFUS) stimulation for activation and suppression of neural activity has recently gained more attention due to its improved spatial resolution of millimeter scale relative to its noninvasive counterparts. Conventional tFUS technologies with single-element ultrasound transducers and off-the-shelf driver electronics have limited utility (e.g., fixed/limited brain targeting, bulky) and instrumentation variation limits comparisons that can be made between studies from different labs. The MUBA system will be a lightweight, out-of-the-box solution that researchers can use for dynamic neuromodulation of virtually any region of the brain of awake and behaving research subjects. Aim 1: Optimize, build, and test lightweight MUBA system. Acceptance Criteria. Optimized linear array integrated with beamforming chip, for 2D targeting with millimeter-scale spatial resolution and at least 1 MPa ultrasound pressure at the focal zone. Demonstrate this performance in 10 replicate systems fabricated by AMI team. Aim 2: Validate the MUBA system for precise and effective neuromodulation of brain targets via electrophysiology and immunohistochemistry. Acceptance Criteria: Demonstrate ability to produce millimeter- scale neural activation areas (c-fos immunohistochemistry) at cortical and sub-cortical depths, and steerable excitation (reproducibly and predictably evoked motor response across multiple MUBA systems).


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 = $0 )
2025	2023	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	2/7/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $315,986 )
2023	2023	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	5/10/2023	SUPPLEMENT FOR EXPANSION	$24,129
2023	2023	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	2	8/23/2023	NON-COMPETING CONTINUATION	$267,728
2023	2023	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	5/11/2023	SUPPLEMENT FOR EXPANSION	$24,129
2023	2023	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	1	6/8/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $315,986

Issue Date FY: 2022 ( Subtotal = $450,304 )
2022	2022	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/31/2022	NEW	$450,304
														Subtotal = $450,304

Grand Total All Awards = $766,290

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Development of a Miniaturized Wearable Ultrasonic Beam-forming Device for Localized Targeting of Brain Regions in Freely-moving Experimental Subjects

Award Number: R43NS126007

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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