Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R34DA050292-01
HEALthy ORCHARD: Developing plans for a Baltimore site of the HEALthy BCD study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA JOHNS HOPKINS UNIVERSITY FALLIN, M DANIELE Baltimore, MD 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

Researchers will expand a recently initiated pregnancy cohort at Johns Hopkins University (JHU) called ORCHARD (ORigins of Child Health And Resilience in Development) to create a Baltimore HEALthy BCD site, named HEALthy ORCHARD. The research team will convene investigators at JHU and the Kennedy Krieger Institute (KKI), and community partners across nine work groups to: (1) develop protocols for recruitment and retention of pregnant mothers and children with enriched sampling of pregnant women who are using substances; (2) establish community, medical, and government partnerships necessary to implement recruitment, retention, data collection and community benefits; (3) characterize the critical ethical and legal challenges raised during study design, in pilot studies, and by prospective participants, and propose solutions where possible and additional research where necessary; (4) develop protocols for longitudinal data collection across pregnancy and childhood; and (5) contribute to multi-site protocol development and nationally relevant principles regarding ethical and legal issues.
1OT2OD030208-01
Helping to End Addiction Long-term (HEAL) Data Platform Office of the Director UNIVERSITY OF CHICAGO GROSSMAN, ROBERT L. CHICAGO, IL 2020
NOFO Number: OTA-20-007
Summary:

The HEAL Initiative is establishing a HEAL Data Ecosystem to help investigators manage and share HEAL-generated data, and quickly and efficiently disseminate HEAL results broadly to stakeholders. The HEAL Platform, built by the University of Chicago, will enable broad sharing of HEAL data by linking data stored in various locations, annotated and curated to various extents, to one central interface where studies, data, and digital assets can be discovered and accessed via metadata query. The Platform will also provide secure workspaces so that under appropriate conditions, data can be pulled from disparate repositories and computed on in the same cloud space, using tools and analytic suites provided within. The Platform team will collaborate closely with the HEAL Data Stewardship Group (Renascence Computing Institute at the University of North Carolina Chapel Hill and RTI, International) to meet the needs and goals of the HEAL Data Ecosystem.
3U44NS115111-03S1
High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain Preclinical and Translational Research in Pain Management NINDS MICRO-LEADS, INC. MCLAUGHLIN, BRYAN L Somerville, MA 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:

This research seeks to develop a high-resolution spinal cord stimulation therapy for treating chronic neuropathic pain of the lower extremities, groin, and lower back. Systems that use wireless communication methods require robust strategies to prevent various forms of cyberattacks on implantable devices. The focus of this project's research will be to develop a new cybersecurity risk-reduced architecture for Bluetooth low-energy implant communication.
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.
3U44NS115111-02S1
High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain Preclinical and Translational Research in Pain Management NINDS MICRO-LEADS, INC. MCLAUGHLIN, BRYAN L Somerville, MA 2020
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA18-591
Summary:

This project aims to develop and clinically validate a 64-channel spinal cord stimulation therapy for treating chronic neuropathic pain of the lower extremities, groin, and lower back. With an increased channel count and the ability to precisely target medial and lateral structures of the spinal cord, the system will treat chronic pain with greater efficacy and reduced side effects. This project will pursue a safe, effective, and non-addictive treatment for neuropathic pain through the testing of enhanced HD64 active leads to be manufactured under GMP regulations. The leads will then undergo electrical, mechanical, biocompatibility, and sterilization testing before being tested in a 10-subject early feasibility study.