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SmartStim, a novel implantable neuromodulation system to cure chronic pain.

Award Number: R18EB037604
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)
PERIOD OF PERFORMANCE START DATE: 08/15/2025
PERIOD OF PERFORMANCE END DATE: 07/31/2028

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SmartStim, a novel implantable neuromodulation system to cure chronic pain. - Project Summary/Abstract Chronic pain without apparent tissue damage is characterized by central sensitization at the level of spinal cord and brain, which often results from prolonged peripheral sensitization of nociceptors, consisting of small-diameter Aδ- and C-fiber afferents with cell bodies in the DRG. Our goal is to develop a novel treatment for chronic pain that provides sustained relief by targeting the root cause: reversing the underlying neural sensitization. The objective is the translational development of a combined device/drug treatment for chronic pain that utilizes a SmartStim device and a long-lasting, safe nerve block reagent to synergistically achieve selective blockage of peripheral nociceptors, especially C-fiber nociceptors. Existing neuromodulation methods, such as spinal cord stimulation, typically mask pain by inducing paresthesia but fail to address the underlying cause, leading to diminishing efficacy over time. The proposed SmartStim system addresses this by offering tunable and selective transmission blockage of sensitized nociceptive afferents through a combination of electrical stimulation and localized drug release at the level of DRGs. Prolonged suppression of peripheral nociceptive drive, especially from C-fiber nociceptors, can potentially engage central plasticity, eventually reversing the disease state of central sensitization. Additionally, the SmartStim system employs similar mechanical design and implantation methods as conventional DRG stimulators and also provides comparable paresthesia-based therapy to suppress pain, making it a safe and significant upgrade over existing DRG stimulators. Three Aims are proposed. Aim 1 will develop an implantable pulse generator (IPG) to deliver two proprietary stimulation protocols for blocking nociceptive afferents. Aim 2 will develop localized NaKA inhibition to enhance the therapeutic effect of DRG stimulation in blocking nociceptive afferent transmission. Aim 3 will develop the prototype of the SmartStim system and conduct system validation. Successful development of SmartStim will lead to a paradigm shift in chronic pain management, offering a mechanism-based and sustainable treatment option for patients who have not found relief with existing therapies.


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: 2026 ( Subtotal = $0 )
2026	2025	UNIVERSITY OF CONNECTICUT	438 WHITNEY RD EXTENSION UNIT 1133	STORRS	CT	06269	CAPITOL	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	12/9/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $3,473,616 )
2025	2025	UNIVERSITY OF CONNECTICUT	438 WHITNEY RD EXTENSION UNIT 1133	STORRS	CT	06269	CAPITOL	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	8/15/2025	NEW	$3,473,616
														Subtotal = $3,473,616

Grand Total All Awards = $3,473,616

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SmartStim, a novel implantable neuromodulation system to cure chronic pain.

Award Number: R18EB037604

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

PERIOD OF PERFORMANCE START DATE: 08/15/2025

PERIOD OF PERFORMANCE END DATE: 07/31/2028

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