Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1K24NS126570-01
Mentorship in Precision Pain Medicine via the Early Phase Pain Investigation Clinical Network Clinical Research in Pain Management NINDS Brigham and Women's Hospital Edwards, Robert R Boston, MA 2021
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193
Summary:

Throughout clinical pain research, there is a need to increase the workforce of researchers familiar with individualized treatment strategies known as precision pain medicine. This mentoring award will leverage EPPIC-Net’s Clinical Coordinating Center resources to encourage interest in clinical pain management, in particular through multidisciplinary pain research projects. A selected clinician-researcher  will mentor early career investigators and provide them with hands-on training activities and other skill-building experiences in clinical pain research, with a focus on precision pain medicine, biomarker development, and pain assessment. Mentoring activities will include formal educational coursework, inclusion in EPPIC-Net working groups, and collaborative writing experiences.
3UG1CA189824-08S2
Developing and Implementing a Culturally Appropriate Non-Opioid Pain Coping Skills Training Intervention for Spanish-Speaking Hispanic/Latinx Patients with Cancer Pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI WAKE FOREST UNIVERSITY HEALTH SCIENCES LESSER, GLENN J Winston-Salem, NC 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Cancer remains a leading cause of death among Hispanic/Latino populations in the United States. Compared with non-Hispanic Whites, Hispanic/Latino cancer patients are more likely to experience poor quality of life and inadequate cancer-related care, including less effective pain relief and poor patient‒provider communication. Additionally, Hispanic/Latino populations often have inadequate access to pain treatment, due to both social disparities and language barriers. However, most behavioral and psychosocial oncology research continues to focus on non-Hispanic Whites, and empirically validated and effective treatment interventions, particularly psychosocial interventions, are often not available in Spanish. This project will generate a Spanish-language version of the painTRAINER internet-based coping skills training program that is both linguistically and culturally sensitive and will evaluate its feasibility and acceptability in Hispanic/Latino patients with persistent cancer-related pain.
3U24NS115678-01S1
Increasing Diversity and Community Engagement in EPPIC-Net Research at the University of Washington Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF WASHINGTON BACKONJA, MIROSLAV MISHA Seattle, WA 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve pain management by discovering and validating biomarkers and non-opioid pain medications. This award will leverage the resources at the University of Washington’s EPPIC-Net’s Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. The site’s network spans multiple states and specialties, allowing access to geographically and demographically diverse patient populations, including underrepresented and underserved populations. 
3UH3AR076573-03S1
Improving representation of non-Hispanic Black and Hispanic study participants in a trial of virtual reality for chronic lower back pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS CEDARS-SINAI MEDICAL CENTER SPIEGEL, BRENNAN Los Angeles, CA 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Digital health interventions, such as virtual reality (VR) applications, have become available for the treatment and monitoring of numerous health conditions, including pain management. A current HEAL-funded study is evaluating the role of a therapeutic VR approach for chronic low back pain. However, racial and ethnic disparities exist in patient access and response to such VR applications, as well as in the incidence and reporting of pain. For example, non-Hispanic Blacks and Hispanics are more likely to report severe pain than non-Hispanic Whites, yet are less likely to have access to digital health information and interventions. To address these disparities, this project will develop a framework to advance diversity and inclusion in digital health trials and will seek to increase the proportion of non-Hispanic Black and Hispanic participants in the ongoing VR trial by tailoring recruitment materials and using novel artificial intelligence-driven cohort building tools.
1K24NS126861-01
Promoting high-quality chronic pain treatment trials through mentorship of junior investigators: A focus on study conduct and method development Clinical Research in Pain Management NINDS UNIVERSITY OF ROCHESTER Gewandter, Jennifer Rochester, NY 2021
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193
Summary:

Enhancing the workforce of pain investigators and practitioners is a key goal of the NIH HEAL Initiative. This mentoring award leverages the resources at one of EPPIC-Net’s Specialized Clinical Centers to encourage interest in clinical pain management, in particular through multidisciplinary pain research projects. A selected investigator will train early career clinical researchers on how to develop and validate relevant pain measures and outcomes in chronic pain conditions, including chemotherapy-induced peripheral neuropathy and neuropathic chronic low back pain. Mentoring activities will include formal research and analysis, active inclusion in EPPIC-Net working groups, and collaborative writing experiences.
3U24NS114416-01S1
Administrative Supplement to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in EPPIC NET Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS DUKE UNIVERSITY LIMKAKENG, ALEXANDER TAN Durham, NC 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve non-opioid pain management. This award will leverage the resources at one of EPPIC-Net’s Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. Since environmental, cultural, and genetic factors may account for observed differences in pain responses between racial and ethnic groups, enrollment of a diverse sample in pain research is crucial to obtain a complete understanding of the effectiveness of any proposed pain therapeutic intervention. The success of these activities will be evaluated, and a toolkit will be created to define best practices that can be by other EPPIC-Net sites and additional trials.
9R42NS120548-02A1
Development of KLS-13019 for Neuropathic Pain Cross-Cutting Research Small Business Programs NINDS KANNALIFE SCIENCES, INC. BRENNEMAN, DOUGLAS ERIC (contact); WARD, SARA J Lloyd Harbor, NY 2021
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-009
Summary:

Neuropathic pain adversely affects quality of life and remains challenging to treat, presenting high unmet medical need. One example of this type of pain, chemotherapy-induced peripheral neuropathy, is a chronic, severely debilitating consequence of cancer therapy for which there are no effective treatment strategies. This research is testing a new cannabidiol (CBD) analogue (KLS-13019) with neuroprotective properties and which has improved drug-like properties compared to CBD. This project will optimize the process to manufacture KLS-13019, develop analytical methods, optimize its formulation, evaluate its safety and toxicity, and test KLS-13019’s efficacy of in a rat model of chemotherapy-induced peripheral neuropathy.
3U24NS113844-03S1
EPPIC-NET DCC Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS NEW YORK UNIVERSITY SCHOOL OF MEDICINE TROXEL, ANDREA B (contact); YU, CHANG New York, NY 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

There is a clear public health imperative to improve the care and outcomes of people who experience severe acute and chronic pain. The Early Phase Pain Investigation Clinical Network (EPPIC-Net) is charged with conducting deep phenotyping and biomarker studies for specific pain conditions – and with conducting high-quality phase II clinical trials to test novel non-opioid pain treatments with academic and industry partners. This research will extend EPPIC-Net’s current portfolio to develop novel and efficient data-analytic methodologies for complex medical data, such as those that are expected to be generated by the clinical trials conducted by EPPIC-Net.
1K24NS126781-01
Mentoring in discovery and validation of clinical chronic pain biomarkers Clinical Research in Pain Management NINDS STANFORD UNIVERSITY Mackey, Sean C Stanford, CA 2021
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193
Summary:

Enhancing the workforce of pain investigators and practitioners is a key goal of the NIH HEAL Initiative. This mentoring award will allow a selected investigator to train early career investigators in patient-oriented research focusing on the development of diagnostic and prognostic biomarkers for high-impact chronic pain. Mentoring activities will include training in designing and implementing pain research studies, preparing scientific papers and presentations, writing successful grant applications, the responsible conduct of research, and successful navigation of the academic process to achieve scientific independence. This training will allow mentees to advance their independent careers as pain researchers.
3U24NS113850-03S1
Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network - Murray Supplement Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS MASSACHUSETTS GENERAL HOSPITAL FAVA, MAURIZIO (contact); EDWARDS, ROBERT R; RATHMELL, JAMES P Boston, MA 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-21-048
Summary:

Key goals of the NIH HEAL Initiative are improving non-opioid pain management and expanding the workforce of clinical researchers working on individualized pain treatments know as pain precision medicine. This award enables an exceptional early career clinician with the opportunity to obtain expertise with high-quality pain-related biomarker assessment methods and biomarker-informed clinical trial design. This research centers on eating-related gastrointestinal functional/motility pain disorders – an understudied area of clinical pain science – and will prepare the clinician to be a future leader in the clinical pain research community.
1R44HD107822-01
A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management Cross-Cutting Research Small Business Programs NICHD HILLMED, INC. DIAS, NICHOLAS Katy, TX 2021
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.
3UG1CA189824-08S1
Wake Forest NCORP Research Base Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI WAKE FOREST UNIVERSITY HEALTH SCIENCES LESSER, GLENN J Winston-Salem, NC 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

Cancer remains a leading cause of death among Hispanic/Latino populations in the United States. Compared with non-Hispanic Whites, Hispanic/Latino cancer patients are more likely to experience poor quality of life and inadequate cancer-related care, including less effective pain relief and poor patient‒provider communication. Additionally, Hispanic/Latino populations often have inadequate access to pain treatment, due to both social disparities and language barriers. However, most behavioral and psychosocial oncology research continues to focus on non-Hispanic Whites, and empirically validated and effective treatment interventions, particularly psychosocial interventions, are often not available in Spanish. This project will generate a Spanish-language version of the painTRAINER internet-based coping skills training program that is both linguistically and culturally sensitive and will evaluate its feasibility and acceptability in Hispanic/Latino patients with persistent cancer-related pain.
1K24AR081143-01
Mentorship of Junior Investigators on HEAL-SKOAP Clinical Research in Pain Management NIAMS JOHNS HOPKINS UNIVERSITY Campbell, Claudia Michelle Baltimore, MD 2021
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193
Summary:

The HEAL-funded Sequenced-strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP) clinical trial evaluates behavioral, pharmacologic, and procedural interventions for patients with knee osteoarthritis pain. It is designed to mimic clinical care for these patients by first testing the effectiveness of conservative and nonsurgical interventions before considering surgical interventions. It is a large-scale clinical trial with a novel design that evaluates multidisciplinary treatments. Therefore, it offers a unique training opportunity for junior investigators from various disciplines who are interested in pain research and management. This mentoring award will allow a selected investigator to train junior investigators by providing protected, mentorship-focused time.
3U24NS112873-03S2
Clinical Coordinating Center for the Acute to Chronic Pain Signatures Program: Administrative Supplement Clinical Research in Pain Management Acute to Chronic Pain Signatures Program NINDS UNIVERSITY OF IOWA SLUKA, KATHLEEN A Iowa City, IA 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed) 
NOFO Number: NOT-NS-21-048
Summary:

The Acute to Chronic Pain Signatures (A2CPS) Program aims to identify combinations of biomarkers that predict susceptibility or resilience to the development of chronic pain. This career enhancement award will help a promising postdoctoral trainee gain access to tools and develop skills needed to pursue a career in clinical pain research. The research involves conducting collaborative multi-site cohort studies and analyzing A2CPS data to determine if a combination of metabolic and psychosocial biomarkers can be used to explain pre-surgery differences in pain, function, and disability in patients with severe knee osteoarthritis.
1R43NS124421-01A1
Development of Nav1.7 Monoclonal Antibodies for Treating Pain Cross-Cutting Research Small Business Programs NINDS INTEGRAL MOLECULAR RUCKER, JOSEPH BENJAMIN Philadelphia, PA 2021
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Many current pain relief treatments rely on use of opioid drugs. This research is conducting preclinical development on a non-addictive, non-opioid therapeutic that uses antibodies to target the sodium channel Nav1.7. This channel is known to be one of the primary routes for generating pain signals – thus it is a target for reducing pain. The antibody approach offers potential for greater specificity than small molecule approaches, potentially resulting in fewer side effects.
3UH3AT010621-03S2
Group-Based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Clinical Research in Pain Management NCCIH BOSTON MEDICAL CENTER MORONE, NATALIA E Boston, MA 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Mindfulness has been shown to be effective in treating chronic low back pain, but it has not been embedded into routine clinical care. The OPTIMUM study (Optimizing Pain Treatment In Medical settings Using Mindfulness) will address barriers to delivering mindfulness in primary care and determine the effectiveness in this setting. This project extends the stakeholder engagement efforts of the OPTIMUM study by increasing the size and responsibilities of the Community Advisory Board, adding focus groups for participants in both study arms, and collecting stories from study nonparticipants about their experience seeking care for chronic low back pain and their views on participating in research. This expanded effort will optimize recruitment of a diverse and underrepresented sample, maximize retention, and prepare for future implementation and dissemination.
1K24AT011995-01
Providing training in effective non-opioid options for the treatment of pain conditions Clinical Research in Pain Management NCCIH UNIVERSITY OF ILLINOIS AT CHICAGO Doorenbos, Ardith Z Chicago, IL 2021
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193
Summary:

Over-the-counter medicines such as non-steroidal anti-inflammatory drugs are ineffective for treating severe chronic pain and may have serious side effects from continued use, which limits treatment options. A kinase (an enzyme whose activity targets a specific molecule) called TAK1 is involved in the chronic pain process. This research will develop a molecule previously shown to be effective in a model of inflammatory pain that also inhibits TAK1. A main goal will be to determine if this inhibitor (takinib analog HS-276) can cross the blood-brain barrier and, if successful, pursue FDA  Investigative New Drug-enabling safety studies leading to a Phase I clinical trial and a potential new chronic pain treatment.
3U24NS113784-01S1
University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF ROCHESTER MARKMAN, JOHN DOUGLAS Rochester, NY 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-21-048
Summary:

Improving pain treatment for is a major goal of the NIH HEAL Initiative. This award supports an early career physician toward achieving a future in clinical pain research and in conducting phase II clinical trials focused on pain. Research activities will provide this individual with the skills needed to serve as a primary investigator for future clinical trials in chronic pain and will help to answer a key question that could improve the design of analgesic clinical trials for neurogenic intermittent claudication, a distinct form of chronic low back pain for which no available treatment exists.
1R43NS120617-01A1
Chemokine-receptor profiling for painful diabetic neuropathy in biological samples from human clinical trials Cross-Cutting Research Small Business Programs NINDS PLUMERIA THERAPEUTICS, INC. RICHARDSON, THOMAS P (contact); WANG, YIPING Plainsboro, NJ 2021
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Chronic pain is a major healthcare burden. However, the types and underlying mechanisms of pain vary greatly, as do patient responses to currently available pain medications. Inflammation in the nervous system (neuroinflammation) is involved in several types of pain, and targeting key molecules involved in neuroinflammation is therefore a promising treatment approach. The chemokine receptor system, a complex network of more than 20 different receptors and more than 80 molecules that bind to these receptors, has a central role in neuroinflammation. Researchers do not yet fully understand the functioning of this network and how specific receptors vary in different chronic pain conditions. Therefore, this project aims to further characterize the expression of one specific receptor, using samples collected from participants in clinical trials evaluating a compound that interferes with the receptor’s function. This information should allow researchers to classify pain patients and identify those most likely to benefit from a treatment with compounds targeting the receptor.
3UH3AT010739-03S1
Improving Diversity, Inclusion, and Retention in BackinAction/AcuOA Clinical Research in Pain Management NCCIH KAISER FOUNDATION RESEARCH INSTITUTE SHERMAN, KAREN J Oakland, CA 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Participants in many clinical trials do not represent the U.S. population. Racial/ethnic minorities are often underrepresented, as are people with lower socioeconomic status and lower education levels, who face additional barriers, such as lack of transportation or childcare. Thus, both recruitment and retention of such populations is challenging, particularly for complementary and integrative health trials. This project proposes to enhance diversity, inclusion, and retention of participants in an ongoing study by creating a patient and caregiver Diversity, Recruitment, and Retention Advisory Board as well as adding a recruitment and retention specialist to coordinate the advisory board and implement necessary activities. The project will also provide evidence-based recruitment tools and will conduct structured interviews with patients who choose not to participate in a study as well as those who are at risk of dropping out to enhance understanding of the barriers and factors contributing to trial recruitment, loss to follow-up, and successful completion.
3UH3CA261067-02S1
Optimizing the use of ketamine to reduce chronic postsurgical pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI NEW YORK UNIVERSITY SCHOOL OF MEDICINE WANG, JING (contact); DOAN, LISA New York, NY 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

Social determinants of heath may affect breast cancer diagnosis and disease staging at time of mastectomy. It is unclear if socioeconomic factors such as annual income, marital status/single parent household, number of children, distance from the hospital, and other life stressors facing individuals from under-resourced populations affect development of postmastectomy pain syndrome or response to the drug ketamine. This research will analyze these factors toward mitigating post-mastectomy pain. This analysis will also serve as the basis for further research to define pathways that minimize health disparities plays in the development of chronic, post-surgical pain. The ultimate goal of this research is to normalize risk for chronic pain after breast surgery.

 
3U19AR076725-01S2
HEALing LB3P: Profiling Biomechanical, Biological and Behavioral phenotypes Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF PITTSBURGH AT PITTSBURGH SOWA, GWENDOLYN A Pittsburgh, PA 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-21-048
Summary:

Identifying optimal chronic low back pain treatments on a patient-specific basis is an important and unresolved challenge. Tailoring interventions according to patient movement characteristics is one option. This research is characterizing patients based on spinal motion during functional tasks and daily activities and will use artificial intelligence to objectively characterize motions of the spine during both clinical assessments and day-to-day life. During clinical assessments, participants will be asked to perform functional tasks while wearing motion sensors. Data collected from the sensors will be used to identify tasks of interest, such as activities of daily living and aberrant/painful motions. An artificial intelligence approach will then interpret data collected continuously during assessment in patients’ homes over a 7-day testing period. Ultimately, this data could be used to help clinicians tailor treatments that are responsive to a patient’s real-world functional impairments.
1R43NS120410-01A1
Optimization of a Gene Therapy for Chronic Pain in Human DRGs Cross-Cutting Research Small Business Programs NINDS NAVEGA THERAPEUTICS, INC. MORENO, ANA MARIA (contact); ALEMAN GUILLEN, FERNANDO La Jolla, CA 2021
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: NS-20-011
Summary:

To avoid the reliance on opioids for treatment of pain, researchers are investigating alternative approaches to disrupt the transmission of pain signals by specialized neurons in the body, such as dorsal root ganglion neurons in the spinal cord. Molecules called voltage-gated sodium channels that are located in the membranes of dorsal root ganglion neurons are essential for transmission of the pain signals. People carrying a specific variant of these channels, NaV1.7, are insensitive to pain; therefore, strategies to block this particular channel might help in the development of non-addictive pain treatment approaches. Navega Therapeutics is developing an innovative gene therapy that specifically targets NaV1.7. Using studies in human cell lines, they will identify the best designs to then test this gene therapy approach in human dorsal root ganglion neurons.
3UH3AR076573-03S2
Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity: Understanding Patient Predictors of Response Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS CEDARS-SINAI MEDICAL CENTER SPIEGEL, BRENNAN Los Angeles, LA 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

Although digital health technologies are now widely available for both therapeutic and monitoring applications, there are wide variations in patient knowledge, attitudes, beliefs, and preferences regarding their uptake and effectiveness. There are also sociodemographic variations in willingness to participate in digital health research studies, both for chronic pain and other common disorders. However, few efforts have systematically examined patient-level predictors of digital health uptake and benefit among diverse individuals who experience chronic pain. This research will employ mixed methods to examine variations in engagement and benefit among diverse participants in a large clinical trial examining the benefits of virtual reality for treatment of chronic lower back pain.
3U19AR076734-01S3
University of Michigan BACPAC Mechanistic Research Center Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF MICHIGAN AT ANN ARBOR CLAUW, DANIEL J Ann Arbor, MI 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-21-048
Summary:

There are numerous pharmacological and non-pharmacological interventions for chronic low back pain, yet no treatment is universally effective. This award supports an early career physician to develop skills to prepare for a career in clinical pain research in an environment aiming to understand patient characteristics that predict differential responses to pain interventions and thus allow for tailored treatments. This research assesses the impact of mindfulness-based stress reduction on pain interference reported by people with chronic low back pain and explores neurobiological effects of mindfulness-based stress reduction through advanced imaging and clinical assessments.