Funded Projects

NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
NOFO Number: RFA-NS-22-037
Summary:

Asian American women who have survived breast cancer and who also have depression are less likely to receive adequate pain treatment due to cultural stigma attached to breast cancer, cultural attitudes about living with pain and symptoms, and language barriers. This project will use a personalizable, technology-based approach to treat cancer pain and depression in Japanese American, Chinese American, and Korean American women who have survived breast cancer. The intervention will accommodate flexibility, accessibility, and anonymity: three factors that have historically hindered effective pain management for this population of breast cancer survivors.

NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
NOFO Number: RFA-NS-20-010
Summary:

Research shows that individuals with chronic pain may experience brain changes that contribute to anxiety, depression, and cognitive impairment. This project will test a user-friendly, home-based device to treat chronic pain. The device stimulates the brain through olfactory training: repetitive daily stimulation with specific smells. The research will optimize a treatment approach and test the device in a clinical study.

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574
Summary:

There is a need for safe, effective, well- tolerated drugs to treat painful neuropathy by halting or reversing the underlying pathology of the disease. One promising approach to treating painful neuropathy without opioids is the use of ghrelin, a 28-amino acid acylated peptide hormone. However, it has a short half-life and must be delivered via a constant intravenous infusion to have a therapeutic effect. Extend Biosciences' D-VITylation platform technology is truly enabling for small peptide-based therapeutics that are rapidly cleared from the bloodstream by renal filtration. The platform harnesses the naturally long half-life of vitamin D and its dedicated binding protein, VDBP. When the vitamin D molecule is conjugated to a biological therapeutic, it dramatically improves the half-life and bioavailability of the drug. Use of the technology should also allow the drug to be self-administered by subcutaneous injection. This would be of significant benefit to patients. In this project, the team will test the efficacy of EXT405 in a cell-based model of neuropathy as well as in animal models of CIPN and diabetes- induced neuropathy.

NOFO Title: HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management
NOFO Number: RFA-AT-22-003
Summary:

Pain in the muscles and surrounding connective tissue (myofascial pain) is a significant health concern affecting hundreds of millions of Americans.  Myofascial pain is primarily diagnosed by asking people about their amount of pain as well as through a physical examination. Both approaches are imprecise ways to diagnose the specific type of pain a patient is experiencing and what is causing it. This project aims to improve myofascial pain management and treatment by developing ways to measure changes to soft tissues (e.g., muscle, connective tissues, nerves, blood vessels) in people with myofascial pain compared with soft tissues in people who are not in pain. The project will develop an imaging biomarker that can distinguish healthy and diseased soft tissues that may contribute to myofascial pain syndrome. The project will then test the ability of these biomarkers to predict patient outcomes in a randomized controlled clinical trial.

NOFO Title: Limited Competition: International Cooperative Biodiversity Groups (U19)
NOFO Number: RFA-TW-13-001
Summary:

This International Cooperative Biodiversity Group application aims to discover and develop small molecule drug leads from cultured marine microbes and diverse coral reef organisms collected from Fiji and the Solomon Islands. Drug discovery efforts will focus on four major disease areas of relevance to the United States and low- and middle-income countries: infectious disease, including tuberculosis and drug-resistant pathogens; neglected tropical diseases, including hookworms and roundworms; cancer; and neurodegenerative and central nervous system disorders. Screening in these therapeutic areas will be performed in collaboration with two major pharmaceutical companies, two highly respected academic groups, and various testing centers and government resources that are available to facilitate drug discovery and development. The acquisition of source material for this program will be linked to biotic surveys, informed by ecological investigations addressing the chemical mediation of biotic interactions, and enriched using ecology-based strategies designed to maximize secondary metabolite production and detection.

NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
NOFO Number: RFA-AR-19-028
Summary:

A primary factor contributing to acute or recurrent back injury is overexertion via excessive peak and cumulative forces on the back and the primary factors involved in the progression of acute low back injury to chronic low back pain (cLBP) include maladaptive motor control strategies, muscle hyperactivity, reduced movement variability, and the development of fear cognitions. This project will focus on the development of robotic apparel with integrated biofeedback components that can reduce exertion; encourage safe, varied movement strategies; and promote recovery. Robotic apparel will be capable of providing supportive forces to the back and hip joints through adaptive control algorithms that respond to dynamic movements and becoming fully transparent when assistance is no longer needed. This technology can be used to prevent cLBP caused by overexertion and provide a new tool to physical therapists and the clinical community to enhance rehabilitation programs.

NOFO Title: HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)
NOFO Number: RFA-DK-18-030
Summary:

Despite the pervasive use of opioid analgesics in the dialysis population and the substantial risks they engender, their efficacy is limited in treating common chronic pain conditions. Most patients receiving long-term opioid therapy continue to experience severe pain and functional limitations. To simultaneously address problems related to chronic pain and opioid use in the U.S. hemodialysis population, this study will evaluate tailored patient-centered interventions to manage pain and reduce opioid use. Patients will be assigned randomly to one of three groups over a 12-month study period: 1) pain care management (PCM) versus 2) PCM plus an online pain self-management program (PSM) that incorporates cognitive behavioral training and is delivered during dialysis sessions, versus 3) control with medication review and education. The study will also evaluate the effectiveness of offering buprenorphine by randomly assigning participants in both active treatment arms to being offered buprenorphine rotation versus continued standard opioid taper support without the option of buprenorphine.

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573
Summary:

 Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of chronic pain (CP) in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of CP [25-28]. However, the most common NIBS methods, e.g., transcranial direct current stimulation, have shown limited, if any, efficacy in treating neuropathic pain. It has been postulated that limitations in conventional NIBS techniques’ focality, penetration, and targeting control limit their therapeutic efficacy . Electrosonic Stimulation (ESStim™) is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue . This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat CP in carpal tunnel syndrome (CTS), both as a lone treatment and in conjunction with physical therapy (PT). Investigators hypothesize ESStim can be provided synergistically with PT, as both can encourage plasticity-dependent changes which could maximally improve a CTS patient’s pain free mobility. In parallel with the CTS treatments, the team will build multivariate linear and generalized linear regression models to predict the CTS patient outcomes related to pain, physical function, and psychosocial assessments as a function of baseline disease characteristics. The computational work will be used to develop an optimized CTS ESStim dosing model. 

NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
NOFO Number: RFA-NS-20-010
Summary:

Chronic pelvic pain affects social and sexual quality of life in up to 20% of women in the United States. It is often managed with physical therapy approaches, but when these measures fail, injection therapies may be indicated. These include injection of botulinum neurotoxin, which leads to muscle relaxation in the pelvic floor and thus pain relief. However, botulinum neurotoxin has dose-dependent side effects and is expensive. Therefore, a precision injection technique to administer botulinum neurotoxin so that it remains effective while minimizing adverse effects and costs is needed. Hillmed Inc. has developed a technique to assess the pelvic floor and choose the optimal injection site, which has improved treatment outcome in initial analyses. They are now aiming to develop a commercializable, personalized precision injection medical device for botulinum toxin and software package that will enable clinicians to optimize botulinum neurotoxin injection. They will then assess the system’s efficacy in a clinical trial of women with chronic pelvic pain and healthy women.

NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-21-016
Summary:

Disruptions in make-up of the microbiome are associated with disorders characterized by chronic pain and inflammation, such as rheumatoid arthritis and fibromyalgia. The gut microbiome has immune and metabolic effects, and human gut-derived bacteria may be a source of novel, safe, and non-addictive pain treatments. However, connections between gut and pain signals, known as the “gut–pain axis,” are still poorly understood. This study aims to identify human-gut-native bacteria that i) interact with known pain targets in lab studies, ii) test their activity and analgesic/anti-inflammatory potential in an animal model, and iii) develop a computational approach to predict microbial-genetic effects on pain signals.

NOFO Title: Notice of Special Interest for HEAL Initiative: Request for Administrative Supplements to Existing Grants for Identification and Validation of New Pain and Opioid Use Disorder Targets within the Understudied Druggable Genome
NOFO Number: NOT-TR-20-008
Summary:

Opioids and other addictive substances have powerful rewarding properties that drive the development of addiction. They also have aversive properties that motivate their avoidance and protect against addiction. This project will explore the role of Type 2 Taste Receptor proteins (Tas2Rs or T2Rs) in regulating the aversive properties of opioids, potentially establishing an entirely new class of receptors that can be targeted for the development of novel addiction therapeutics.

NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
NOFO Number: RFA-NS-19-025
Summary:

The Icahn School of Medicine at Mount Sinai (ISMMS) will support the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), through the ISMMS Department of Neurology as the core of a hub and spokes structure. The study contains four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials. The study team will also increase training opportunities through EPPIC-Net within ISMMS and the larger pain research community, training junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout the network.

NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
NOFO Number: RFA-NS-22-037
Summary:

Opioid overdose deaths disproportionately affect Black individuals in the United States. While the use of complementary and integrative pain treatments is effective and widely recommended, Black pain patients (especially those who also have depression) face barriers to the use of these approaches. This project will refine, test, and prepare to implement a novel approach to overcoming these treatment barriers. The research will partner with and empower Black patients to find safe, effective pain treatments that best match their values, preferences, and lifestyles.