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Translating an MR-guided focused ultrasound system for first-in-human precision neuromodulation of pain circuits

Award Number: UG3NS135551
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Translating an MR-guided focused ultrasound system for first-in-human precision neuromodulation of pain circuits - This proposal responds to PAR-21-315 Blueprint MedTech Translator and aims to translate a next-generation noninvasive neuromodulation system that supports a device-based strategy for non-addictive pain treatments. Specifically, we have developed an integrated magnetic resonance (MR) image-guided focused ultrasound (MRgFUS) stimulation system for targeted and high precision modulation of deep brain regions with real-time targeting feedback and functional monitoring by fMRI. Although there are several devices available on the market to treat pain, their efficacy is limited by imprecise targeting resulting from insufficient mechanistic data about “device-able” targets, and from lack of feedback of effects to modulate the therapy. Reversible FUS stimulation under MRI guidance (MRgFUS) combines the dual neuromodulation capacity of low frequency focal ultrasound with simultaneous monitoring of neuromodulation in action using fMRI. MRgFUS overcomes the limitations of existing pain-treatment devices and has great potential to improve patient outcomes through FUS and MRI technologies that enable targeting and control. Our group has developed an MRgFUS system for non-human primate (NHP) use and successfully modulated neural activity in the brain regions responsible for nociceptive information processing validated by fMRI. As part of previously funded work, we have scaled the device to function with a human skull, and here we propose to translate this early-stage technology into a new non-addictive pain therapy. We have designed the human device to use FUS to stimulate pain targets (thalamic nuclei, ACC, and PAG/PVG) that are currently used in clinical pain treatments with the ability to validate the location of stimulation and to monitor brain activity using blood oxygenation level dependent fMRI. Our experimental plan navigates barriers to deploying FUS, including 1) optimizing MR-based methods to visualize the ultrasound beam with high precision while using safe ultrasound exposure to the brain, 2) assessing device safety in non-human primates, and 3) obtaining regulatory approval for use of the proposed device for a first-in-human trial of high precision MRgFUS in patients with medically-refractory essential tremor and intractable chronic central post-stroke pain. The UG3-phase is designed to prepare the device for human use and has quantitative go/no-go milestones for establishing safe use of high precision MRgFUS in humans with regulatory approval. Successful completion of the UG3 milestones will place this groundbreaking technology into the hands of treating physicians and lead to the first clinical trial of high precision MRgFUS neuromodulation in patients with movement disorders and chronic pain. The proposed work will deliver a system that overcomes technical barriers in transcranial ultrasound and is ready for pilot clinical trials in various pain management applications.


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	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Drug Use and Addiction Research Programs	000	1	10/26/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $4,364,294 )
2023	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Drug Use and Addiction Research Programs	001	1	9/22/2023	NEW	$1,419,237
2023	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Drug Use and Addiction Research Programs	000	1	9/20/2023	NEW	$2,945,057
														Subtotal = $4,364,294

Grand Total All Awards = $4,364,294

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Translating an MR-guided focused ultrasound system for first-in-human precision neuromodulation of pain circuits

Award Number: UG3NS135551

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/20/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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