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Development of a Wireless Endovascular Nerve Stimulator for Treatment ofRefractory Neuropathic Pain

Award Number: U18EB029353
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

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PROJECT SUMMARY Neuropathic pain is a disabling pain syndrome caused by a lesion or disease of the somatosensory system.14 For example, postherpetic neuralgia, trigeminal neuralgia, diabetic neuropathy, amputation, and peripheral nerve injury are all associated with neuropathic pain.14 For patients with neuropathic pain refractory to medical therapy, modulation of specific neural structures in the central or peripheral nervous system, can provide effective alternative treatments.12,13 Dorsal root ganglion (DRG) stimulation is an approved therapy for complex regional pain syndrome (CRPS). The current FDA-approved device on the market for DRG stimulation is generally considered safe, but has been associated with complications such as pulse generator infections and lead migration.17, 18 Our overall goal is to provide a novel, minimally-invasive, and effective treatment for patients with refractory neuropathic pain. We propose a wireless millimeter-sized nerve stimulator that can be delivered through the vasculature and stimulate the DRG. This transformative “endovascular nerve stimulation” (EVNS) technology would have major advantages compared to state-of-the art nerve stimulation therapies for pain. This new concept for pain treatment using these small wireless endovascular stimulators is enabled by the development of magnetoelectric (ME) materials for wireless power delivery to bioelectronic devices.3 The goal of this project is to develop a wireless endovascular magnetoelectric nerve stimulator to stimulate the dorsal root ganglion and alleviate the symptoms of neuropathic pain. Successful completion of this project will establish proof-of-principle and provide early safety/efficacy data on wireless endovascular DRG stimulation for treatment of refractory neuropathic pain. Based on the successful demonstration of DRG stimulation, we will be able to develop EVNS therapies for other neuropathic pain targets. While in this proposal we focus on the treatment of CRPS, successful demonstration of EVNS will provide a platform technology for treating numerous other neuropathic pain syndromes. At the end of the 3-year period, we plan to submit for FDA clearance and to follow with a first in human study and a subsequent clinical trial to test the safety and efficacy of wireless endovascular DRG stimulation in patients with refractory neuropathic pain. Page 7 Project Summary/Abstract


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	2019	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	10/31/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2019	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	2/1/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	12/7/2020	NEW	-$1,535,654
2021	2019	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	003	1	4/21/2021	NEW	-$238,539
2021	2019	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	002	2	2/2/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2021	2019	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	2	12/7/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,535,654
2021	2019	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	004	2	4/21/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$238,539
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $2,345,526 )
2019	2019	BAYLOR COLLEGE OF MEDICINE	ONE BAYLOR PLAZA	HOUSTON	TX	77030	HARRIS	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	9/28/2019	NEW	$2,345,526
														Subtotal = $2,345,526

Grand Total All Awards = $2,345,526

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Development of a Wireless Endovascular Nerve Stimulator for Treatment ofRefractory Neuropathic Pain

Award Number: U18EB029353

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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