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An innovative device for management of neuropathic pain after spinal cord injury

Award Number: UH3NS139014
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: 09/19/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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An innovative device for management of neuropathic pain after spinal cord injury - An innovative device for management of neuropathic pain after spinal cord injury Neuropathic pain (NP) after spinal cord injury (SCI) is common and debilitating, and has increasingly been recognized as an important contributor to suffering, poor rehabilitation outcomes and reduced quality of life. Different non-invasive neurodomulatory techniques via peripheral (TENS) or central (tDCS) electrical stimulation have been used. However, their effectiveness is still limited and controversial. We have recently developed a novel, non- invasive, non-pharmacological intervention – Breathing-controlled electrical stimulation (BreEStim) for neuropathic pain management. Our preliminary work has shown that that BreEStim could produce effective analgesic effects in SCI+NP patients via central neuromodulation mechanisms. Though clinically effective, the BreEStim apparatus is currently a customized apparatus for laboratory use only. A stand-alone BreEStim device is needed for routine clinical use. The planned BreEStim device will be developed by our industry partner, Soterix Medical Inc (SMI). The device will then be tested in a single-center randomized controlled clinical trial at our research center. Accordingly, we would like to pursue the following specific aims. UG3 Specific Aim 1: Develop an integrated BreEStim device under FDA Quality Systems UH3 Specific Aim 2: Examine efficacy and safety of BreEStim in a single-center randomized controlled clinical trial UH3 Specific Aim 3: Iterate device hardware, obtain IEC certification, and advance regulatory process. At the completion of this project, pending promising clinical outcome, the results will establish that the developed BreEStim device is safe and effective. We will accordingly engage the FDA on the evidence needed to support the intended use. If a larger multicenter trial is necessary for marketing clearance, we will engage the FDA about trial design and pathway for approval. UTHealth and SMI have reached an agreement to facilitate product development, IP acquisition, translation and commercialization.


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 = $800,027 )
2026	2026	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON	7000 FANNIN ST FL 9	HOUSTON	TX	77030	HARRIS	USA	Drug Use and Addiction Research Programs	000	2	9/17/2026	EXTENSION WITH OR WITHOUT FUNDS	$800,027
														Subtotal = $800,027

Grand Total All Awards = $800,027

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An innovative device for management of neuropathic pain after spinal cord injury

Award Number: UH3NS139014

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: 09/19/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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