Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1UG3NS135551-01
Translating an MR-guided focused ultrasound system for first-in-human precision neuromodulation of pain circuits Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS VANDERBILT UNIVERSITY MEDICAL CENTER CASKEY, CHARLES F (contact); CHEN, LI MIN Nashville, TN 2023
NOFO Title: Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-21-315
1R18EB035019-01
POWS for NOWS: Using Physiomarkers as an Objective Tool for Assessing the Withdrawing Infant Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB UNIVERSITY OF VIRGINIA SULLIVAN, BRYNNE ARCHER (contact); VESOULIS, ZACHARY ANDREW Charlottesville, VA 2023
NOFO Title: HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-22-002
Summary:

Infants exposed to opioids during pregnancy can develop neonatal opioid withdrawal syndrome (NOWS). To date, clinicians generally use subjective evaluation to determine if an infant has NOWS, how severe the condition is, and if the infant needs treatment with or without medications. This project will evaluate whether an objective physiologic measure—continuous measurement of oxygen levels in the infant’s blood—can be used to develop a scoring system for assessing NOWS severity. The project will also develop and test a device to continuously monitor blood oxygen levels in the infants.
1RM1NS128956-01A1
Mechanisms of Action of Peripheral Nerve Stimulation for the Treatment of Chronic Neuropathic Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS STANFORD UNIVERSITY HAH, JENNIFER (contact); BISWAL, SANDIP; CHADWICK, ANDREA LYNN Stanford, CA 2023
NOFO Title: HEAL Initiative: Interdisciplinary Team Science to Uncover the Mechanisms of Pain Relief by Medical Devices (RM1 Clinical Trial Optional)
NOFO Number: RFA-NS-23-003
Summary:

Technology approaches that deliver electrical current through the skin near a damaged or injured peripheral nerve are used to treat chronic neuropathic pain that does not respond to other treatments. This project will optimize this nerve stimulation approach while also determining how the stimulation works to reduce pain in the body. The research will also look for patient characteristics that predict response by conducting a clinical trial comparing combined peripheral nerve stimulation and conventional medical treatment to medication alone.
1R18EB035004-01
Point of Care Diagnostic for Sickle Cell Disease Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB DUKE UNIVERSITY WAX, ADAM Durham, NC 2023
NOFO Title: HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-22-002
Summary:

People with sickle cell disease often experience episodes of severe pain (vaso-occlusive crisis) that are caused by the abnormal red blood cells and frequently result in opioid use. Tools that can identify and measure the degree of such a crisis early on could allow clinicians to pre-emptively disrupt this process. This project aims to develop a rapid, automated screening technology for evaluating red blood cells that allows assessment of patients at risk of pain crisis right in their health care provider’s office.
1RM1NS128775-01
Defining Mechanisms of Pain Relief Associated with Dorsal Root Ganglion and Spinal Cord Stimulation Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS University of Pittsburgh KOERBER, H RICHARD (contact); LEMPKA, SCOTT F; WEBER, DOUGLAS J Pittsburgh, PA 2022
NOFO Title: HEAL Initiative: Interdisciplinary Teams to Elucidate the Mechanisms of Device-Based Pain Relief (RM1 Clinical Trial Optional)
NOFO Number: NS22-016
Summary:

Chronic pain is a debilitating condition for which there is a pressing need for safe, effective treatments. Neurostimulation therapies that target nerve structures such as the dorsal root ganglion (DRG) and the spinal cord, have shown promising results for treating chronic pain, but researchers don’t know how they work. This project focuses on two prevailing models used to explain the therapeutic effects of neurostimulation: the gate-control model in which pain signals are blocked from reaching the brain and the T-junction filtering model in which pain signals are blocked from reaching the spinal cord. Strategies will include innovative behavioral, electrophysiological, imaging, and computational modeling techniques. The results of these studies will help explain why neurostimulation therapies work and potentially offer new treatment strategies for improved pain relief.
1RM1NS128741-01
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS Massachusetts General Hospital WAINGER, BRIAN JASON (contact); FREEMAN, ROY ; LOGGIA, MARCO LUCIANO Boston, MA 2022
NOFO Title: HEAL Initiative: Interdisciplinary Teams to Elucidate the Mechanisms of Device-Based Pain Relief (RM1 Clinical Trial Optional)
NOFO Number: NS22-016
Summary:

Spinal cord stimulators (SCS) and related devices are commonly used for hard-to-treat pain conditions, but how they work remains unclear. This knowledge is important for improving device design and stimulation patterns, as well as for determining which patients will benefit. Through a series of clinical studies in patients with SCS devices, this project will explore the hypothesis that SCS devices reduce pain by changing the excitability of peripheral sensory nerve fibers in the spinal cord. The results should guide development of biomarkers to advance research further.
1RM1NS128787-01
Understanding the Mechanistic, Neurophysiological, and Antinociceptive Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS University of Texas Med BR WILKES, DENISE (contact); BADRAN, BASHAR W; HOUGHTON, DAVID C; KHODAPARAST, NAVID Galveston, TX 2022
NOFO Title: HEAL Initiative: Interdisciplinary Teams to Elucidate the Mechanisms of Device-Based Pain Relief (RM1 Clinical Trial Optional)
NOFO Number: NS22-016
Summary:

Despite the need for non-opioid treatments for chronic pain, few alternative treatment approaches exist. Transcutaneous auricular neurostimulation (tAN) is a safe and effective treatment for pain during opioid withdrawal; however, researchers do not understand how tAN reduces pain, which limits its clinical use. A better understanding of how tAN affects neurophysiological processes to provide pain relief would likely expand tAN development and use. This interdisciplinary project will conduct research in both healthy adults and those with chronic pain to explain the neurochemical and neurophysiological mechanisms for tAN-based pain relief, and also help optimize treatments and their use.
1U18EB030609-01
Novel Implantable Device to Negate Post-Amputation Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB NOVAFLUX, INC. LABIB, MOHAMED E (contact); KATHJU, SANDEEP Princeton, NJ 2021
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

Approximately 3.6 million Americans live with an amputated extremity, and the majority of these individuals are likely to suffer from chronic post-amputation pain. There is no consensus as to a recommended therapy for such pain, and many treatments do not provide sufficient pain control. Some studies have shown effective pain suppression from delivering an anesthetic agent directly to an injured nerve. This research aims to develop a device that can be implanted near the injured nerves of an amputated limb to deliver an anesthetic. Findings from this preclinical study will optimize design and delivery features to maximize its effect on pain control for as long as possible without needing a drug refill. The research is expected to advance eligibility for further testing in large animals and humans.
1U18EB030607-01
Non-invasive Nonpharmaceutical Treatment for Neck Pain: Development of Cervical Spine-specific MR-guided Focused Ultrasound System Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS UNIVERSITY OF UTAH RIEKE, VIOLA Salt Lake City, UT 2020
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

Neck pain is the fourth leading cause of disability and also a significant cause of cervicogenic headaches. Many of the currently available neck pain treatments are invasive with associated risks and complications, particularly because of the complex anatomy. Magnetic resonance guided focused ultrasound, a novel, completely noninvasive technique, can precisely target spinal facet joints to help ameliorate neck pain, potentially transforming the current practices. The goal of this study is to develop a cervical spine-specific device and demonstrate its safety and efficacy on targeting cervical sensory fibers and the third occipital nerve. The results of these studies will provide an understanding on how to best use this technology for chronic neck pain as well as a basis for translation into human use.
1UG3NS115108-01A1
Home-based transcutaneous electrical acustimulation for abdominal pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS JOHNS HOPKINS UNIVERSITY CHEN, JIANDE Baltimore, MD 2020
NOFO Title: HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-016
Summary:

Currently, there are no adequate therapies for abdominal pain in patients with Irritable Bowel Syndrome (IBS), a gastrointestinal disorder affecting 14-20% of the US population. More than 40% of IBS patients regularly use opioid narcotics. An alternative treatment for IBS that has been shown to be an effective pain management strategy is electroacupuncture. However its drawbacks include infrequent administration, unclear mechanistic understanding, and lack of methodology optimization. This study will use a noninvasive method of transcutaneous electrical acustimulation (TEA) by replacing needles with surface electrodes and testing acupoints that target peripheral nerves. Based on prior mechanistic and clinical studies, two stimulation parameters and effective acupoints will be tested. In the UG3 phase, the TEA device and a cell phone app will be optimized for use in IBS abdominal pain, and an acute clinical study will determine the best stimulation locations and parameters. During the UH3 phase, an early feasibility clinical study will be performed in 160 IBS patients in treating abdominal pain. Participants will self-administer the therapy at home/work and will be randomized across four treatment groups to determine the therapeutic potential of the TEA system.
3UH3NS113661-02S1
Deep Brain Stimulation of the Subgenual Cingulate Cortex for the Treatment of Medically Refractory Chronic Low Back Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS UNIVERSITY OF CALIFORNIA LOS ANGELES BARI, AUSAF; POURATIAN, NADER Los Angeles, CA 2020
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-18-906 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-023
Summary:

A current obstacle to developing more effective therapies for chronic low back pain is the lack of clinical trials assessing the feasibility and potential effectiveness of promising new targets for neuromodulation. This project will explore the feasibility of using deep brain stimulation of a new brain target for treating chronic low back pain. The study will also explore imaging biomarkers in patients with chronic low back pain that can be used to predict whether someone is a candidate or may respond to deep brain stimulation therapy, to guide programming and patient selection for this therapy in the future.
1UH3NS115647-01A1
A Double-Blind, Randomized, Controlled Trial of Epidural Conus Medullaris Stimulation to Alleviate Pain and Augment Rehabilitation in Patients with Subacute Thoracic Spinal Cord Injury (SCI) Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS DUKE UNIVERSITY LAD, SHIVANAND P Durham, NC 2020
NOFO Title: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-018
Summary:

Pain is a major problem for spinal cord injury (SCI) patients that tends to persist and even worsen with time. No treatments are currently available to consistently relieve pain in SCI patients. This study will investigate the feasibility of Epidural Electrical Stimulation (EES) using the Abbott Proclaim? SCS system with two electrodes to treat neuropathic pain in patients with thoracic spinal cord injury. In this double-blind, prospective, randomized clinical trial, patients with subacute, traumatic, complete thoracic SCIs with American Spinal Injury Association (ASIA) Impairment Scale A will be randomized to receive either ?EES on? (treatment intervention) or ?EES off? (control intervention) of the target regions for pain control (lead overlying the spinal cord anatomy corresponding with their pain distribution) and neurorestoration (lead overlying the conus medullaris) as an adjunct to physical therapy. This study will help determine whether EES can help patients with SCI neuropathic pain and have more widespread clinical applicability.
1U18EB029354-01
Treating pain in sickle cell disease by means of focused ultrasound neuromodulation Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB CARNEGIE-MELLON UNIVERSITY HE, BIN Pittsburgh, PA 2019
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

Researchers will develop a novel transcranial focused ultrasound (tFUS) device for pain treatment and establish its effectiveness for treating sickle cell disease (SCD) pain in humanized mice. The tFUS will target the specific cortical regions involved in SCD pain using a novel non-invasive electrophysiological source imaging technique. The project’s goals have several aims. Aim 1: Develop tFUS devices for pain treatment. The mouse-scale system will be designed to validate the therapeutic effect of stimulating the anticipated cortical targets. This will inform development of the simpler human-scale system, which will use models of the skull to select cost-effective transducers to reach the targets. Aim 2: Evaluate tFUS effectiveness and optimize stimulation parameters in an SCD mice model. Researchers will determine effective tFUS parameters to chronically reduce SCD pain in mice and validate this using behavioral measures. Aim 3: Use electrophysiological source imaging to target and trigger closed-loop tFUS in animal models. This aim also includes performing safety studies to prepare for human trials. The project will develop a transformative, noninvasive tFUS device to effectively and safely treat pain in SCD. 
1UG3NS115637-01
Clinical Translation of Ultrasonic Ketamine Uncaging for Non-Opioid Therapy of Chronic Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS STANFORD UNIVERSITY AIRAN, RAAG D (contact); WILLIAMS, NOLAN R Stanford, CA 2019
NOFO Title: HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-016
Summary:

The research team has developed ultrasonic drug uncaging for neuroscience, in which neuromodulatory agents are uncaged from ultrasound-sensitive biocompatible and biodegradable drug-loaded nanocarriers. This project will clinically translate ultrasonic ketamine uncaging for chronic pain therapy. In the UG3 phase, the research team will scale our nanoparticle production processes to human scales and adapt them to pharmaceutical standards. In the UH3 phase, they will complete a first-in-human evaluation of the safety and efficacy of ultrasonic ketamine uncaging by quantifying how much ketamine is released relative to the ultrasound dose and assessing whether the uncaged ketamine can modulate the sensitivity and affective response to pain, in patients suffering from chronic osteoarthritic pain. This project aims to yield a novel, noninvasive, non-opioid therapy for chronic pain that maximizes the therapeutic efficacy of ketamine over its side effects, by targeting its action to a critical hub of pain processing.
1U44NS115632-01
Implantable Peripheral Nerve Stimulator for Treatment of Phantom Limb Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS RIPPLE, LLC MCDONNALL, DANIEL Salt Lake City, UT 2019
NOFO Title: HEAL Initiative: Translational Devices to Treat Pain (U44 Clinical Trial Optional)
NOFO Number: RFA-NS-19-017
Summary:

The research team will develop an implantable neural stimulation system to provide natural and intuitive sensation for prosthesis users. The nerve cuff technology meets the requirements for a sensory feedback system capable of providing consistent and controlled electrical stimulation. Coupled with a multichannel implantable stimulator, this electrode array will offer substantial improvement over existing options to treat phantom limb pain (PLP). In Phase I, researchers will finalize array architectures for evaluation in cadaver studies, complete integration of electrodes with our stimulator, conduct benchtop verification of electrical and mechanical performance, send implants for third-party evaluation of system biocompatibility, and complete a Good Laboratory Practice animal study to validate safety and efficacy. In Phase II, researchers will conduct a 5-subject clinical study to test the implantable stimulation system. Each unilateral prosthesis user will be implanted for one year as researchers evaluate the safety and efficacy of this implantable device to treat PLP.
1UH3NS115118-01
Transcranial focused ultrasound for head and neck cancer pain. A pilot study Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS UNIVERSITY OF VIRGINIA ELIAS, WILLIAM JEFFREY Charlottesville, VA 2019
NOFO Title: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-018
Summary:

Head and neck cancer is particularly susceptible to nociceptive and neuropathic pains because it is dense with sensitive anatomic structures and richly innervated. Transcranial magnetic resonance imaging–guided focused ultrasound (FUS) is a new stereotactic modality capable of delivering high-intensity energy through the intact human skull with submillimeter precision. This clinical trial will target the spinothalamic and spinoreticular pain circuits by unilateral FUS mesencephalotomy, an effective procedure for cancer pain but limited by the accuracy of its era. The primary aim is to assess the safety and preliminary effectiveness in six head and neck cancer patients with opioid-resistant pain. Researchers will investigate the potential mechanism of pain relief as the mesencephalotomy target involves the confluence of the ascending and descending pain systems. Aims 2 and 3 will investigate these systems with electrophysiology specific for the spinothalamic tract and carfentenil positron emission tomography imaging that measures the brain’s endogenous opioids.
1U18EB029353-01
Development of a Wireless Endovascular Nerve Stimulator for Treatment of Refractory Neuropathic Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB BAYLOR COLLEGE OF MEDICINE KAN, PETER TZE MAN; ROBINSON, JACOB T; SHETH, SUNIL Houston, TX 2019
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

For patients with neuropathic pain refractory to therapy using small molecules, modulation of specific neural structures in the central or peripheral nervous system can provide effective alternative treatments. While current Food and Drug Administration–approved devices for dorsal root ganglion (DRG) stimulation are safe and effective, there have been an unfortunate number of adverse events associated with pulse generator infections and lead migration. The research team will develop a wireless, millimeter-sized nerve stimulator that can be delivered through the vasculature and stimulate the DRG to alleviate symptoms of neuropathic pain and the associated minimally invasive delivery method. This endovascular nerve stimulation (EVNS) system depends on development and integration of key novel technologies into an endovascular stent. The magnetoelectric transducers and electronic circuits will convert wireless power and data into stimulus patterns that can trigger neural activity in the DRG via miniature electrodes. After chronic demonstration of safety and functionality in large animal models, the team will prepare for regulatory discussions with the FDA. If successful, the EVNS will provide a technology platform for treating other neuropathic pain syndromes. 
1UH3NS113661-01
Deep Brain Stimulation of the Subgenual Cingulate Cortex for the Treatment of Medically Refractory Chronic Low Back Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS UNIVERSITY OF CALIFORNIA LOS ANGELES BARI, AUSAF (contact); POURATIAN, NADER Los Angeles, CA 2019
NOFO Title: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-018
Summary:

This study aims to address critical gaps and unmet therapeutic needs of chronic low back pain (CLBP) patients using a next-generation deep brain stimulation (DBS) device with directional steering capability to engage networks known to mediate the affective component of CLBP. Researchers will utilize patient-specific probabilistic tractography to target the subgenual cingulate cortex (SCC) to engage the major fiber pathways mediating the affective component of chronic pain. The objective is to conduct an exploratory first-in-human clinical trial of SCC DBS for treatment of medically refractory CLBP. The research team aims to: (1) assess the preliminary efficacy of DBS of SCC in treatment of medically refractory CLBP; (2) demonstrate the safety and feasibility of SCC DBS for CLBP; and (3) develop diffusion tensor imaging–based blueprints of response to SCC DBS for CLBP.
1U44NS115111-01
High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS MICRO-LEADS, INC. MCLAUGHLIN, BRYAN L Somerville, MA 2019
NOFO Title: HEAL Initiative: Translational Devices to Treat Pain (U44 Clinical Trial Optional)
NOFO Number: RFA-NS-19-017
Summary:

The research team will develop HD64—a high-resolution, 64-channel spinal cord stimulation therapy to provide more pain relief for those suffering from chronic neuropathic pain and opioid dependence. HD64 provides an ultra-thin conformal blanket of stimulation contacts across the width of the spinal cord and enables more precise targeting of the lateral structures of the spinal cord to enhance pain relief. A cadaveric pilot run followed by a non-significant risk intraoperative study will be performed to inform the design parameters of HD64 arrays. The study will evaluate activation of medial and lateral spinal targets. At the end of Phase 1, the clinical feasibility of HD64 surgical leads will be established. In Phase 2, researchers will develop an external active lead pulse generator and charger. They will perform an early feasibility study human trial using active HD64 and mechanical and electrical design verification testing and chronic safety studies in large animals.
1U18EB029257-01
Temporal Patterns of Spinal Cord Stimulation Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB DUKE UNIVERSITY GRILL, WARREN M Durham, NC 2019
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

This project will design and test optimized temporal patterns of stimulation to improve the efficacy of commercially available spinal cord stimulation (SCS) systems to treat chronic neuropathic pain. Researchers will build upon a validated biophysical model of the effects of SCS on sensory signal processing in neurons within the dorsal horn of the spinal cord to better understand how to improve the electrical stimulus patterns applied to the spinal cord. They will use sensitivity analyses to determine the robustness of stimulation patterns to variations in electrode positioning, selectivity of stimulation, and biophysical properties of the dorsal horn neural network. Researchers will demonstrate improvements from these new stimulus patterns by 1) measuring their effects on pain-related behavioral outcomes in a rat model of chronic neuropathic pain and by 2) quantifying the effects of optimized temporal patterns on spinal cord neuron activity. The outcome will be mechanistically derived and validated stimulus patterns that are significantly more efficacious than the phenomenologically derived standard of care patterns; these patterns could be implemented with either a software update or minor hardware modifications to existing SCS products.
1U18EB029251-01
The Injectrode - A Truly Injectable Electrode for Dorsal Root Ganglion Stimulation to Treat Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB UNIVERSITY OF WISCONSIN-MADISON LUDWIG, KIP A (contact); WEBER, DOUGLAS J Madison, WI 2019
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

While traditional epidural spinal cord stimulation (SCS) for intractable pain has been very efficacious for the patients responsive to it, the success rate has held at approximately 55%. Dorsal root ganglion (DRG) stimulation has shown promise in early trials to provide greater pain relief. Although the decrease in back pain at 3 months was significantly greater in the DRG arm vs. SCS, the adverse event rate related to the device or implant procedure was significantly higher in the DRG arm. Researchers will develop the “Injectrode” system to make the procedure simpler and safer by using an alternative to implantation: using an injectable pre-polymer liquid composite that cures quickly after injection adjacent to the DRG. They will compare an Injectrode-based system with traditional electrode stimulation at the DRG as an alternative to opioid administration. Researchers will perform benchtop characterization and refinement as a precursor to a clinical study, use modeling and animal testing to refine the efficiency of energy transfer from a transcutaneous electrical nerve stimulation unit to an Injectrode/Injectrode collector concept, and optimize the procedure for the complex anatomy of the human DRG.
1U18EB029351-01
Development of an MRgFUS system for precision-targeted neuromodulation of pain circuits with simultaneous functional MRI Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB VANDERBILT UNIVERSITY MEDICAL CENTER CASKEY, CHARLES F (contact); CHEN, LI MIN ; GRISSOM, WILLIAM A Nashville, Tennessee 2019
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

This project aims to develop a next-generation noninvasive neuromodulation system for non-addictive pain treatments. The research team will build an integrated system that uses magnetic resonance image-guided focused ultrasound (MRgFUS) stimulation to target pain regions and circuits in the brain with high precision. The system will use MR imaging to locate three pain targets commonly used in clinical pain treatments, to stimulate those targets with ultrasound, and to monitor responses of nociceptive pain circuits using a functional MRI readout. Three collaborating laboratories will tackle the goals of this project: (Aim 1) Develop focused ultrasound technology for neuromodulation in humans, compatible with the high magnetic fields in an MRI scanner. (Aim 2) Develop MRI technology to find neuromodulation targets, compatible with focused ultrasound transducers. (Aim 3) Validate the complete MRgFUS neuromodulation system in brain pain regions in nonhuman primates. By the end of the project, the research team will have a fully developed and validated MRgFUS system that is ready for pilot clinical trials in pain management.
1UH3NS115631-01
Multisite adaptive brain stimulation for multidimensional treatment of refractory chronic pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO SHIRVALKAR, PRASAD San Francisco, CA 2019
NOFO Title: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-018
Summary:

The research team will develop stimulation control algorithms to treat chronic pain using a novel device that allows longitudinal intracranial signal recording in an ambulatory setting. Subjects with refractory chronic pain syndromes will undergo bilateral surgical implant of temporary electrodes in the thalamus, anterior cingulate, prefrontal cortex, insula, and amygdala to identify candidate biomarkers of pain and optimal stimulation parameters. Six patients will proceed to chronic implantation of “optimal” brain regions for long-term recording and stimulation. The team will first validate biomarkers of low- and high-pain states to define neural signals for pain prediction in individuals. They will then use these pain biomarkers to develop personalized closed-loop algorithms for deep-brain stimulation (DBS) and test the feasibility of closed-loop DBS for chronic pain in weekly blocks. Researchers will assess the efficacy of closed-loop DBS algorithms against traditional open-loop DBS or sham in a double-blinded cross-over trial and measure mechanisms of DBS tolerance.
3U54EB033664-03S5
NeuroTech Harbor: Our nation's first equitech ecosystem for neuromedical technologies Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB JOHNS HOPKINS UNIVERSITY SARMA, SRIDEVI V (contact); ETIENNE-CUMMINGS, RALPH ; MANAYE, KEBRETEN F; NWULIA, EVARISTUS A; THAKOR, NITISH VYOMESH; YAZDI, YOUSEPH Baltimore, MD 2024
NOFO Title: Blueprint MedTech: Incubator Hubs (U54 Clinical Trial Not Allowed)
NOFO Number: PAR-21-314
4R33NS113329-02
Discovery of Biomarker Signatures Prognostic for Neuropathic Pain after Acute Spinal Cord Injury Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON HERGENROEDER, GEORGENE W Houston, TX 2024
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041