The “Neuromod Prize” (“the Competition”) is a prize competition of the SPARC (Stimulating Peripheral Activity to Relieve Conditions) initiative of the National Institutes of Health (NIH) that seeks to reward and spur the development of solutions for targeted neuromodulation therapies. This is a multi-phased competition. Previously, NIH announced the first phase of the Competition only. The first phase of the Competition called on scientists, engineers, and clinicians to submit novel concepts and proposals. NIH stated that details of the requirements and registration for subsequent phases are expected to be announced at a future time. Here, NIH announces the second phase of the Competition. Phase 2 is restricted to quarterfinalist winners from Phase 1. Phase 2 calls on quarterfinalists to submit data, methods, and results from experiments described in their Phase1 concept papers, as described more fully below.
A breakthrough moment
Neuromodulation has the potential to treat many conditions in the body through regulation of the nervous system. Recent innovations in device technology and improved understanding of the interactions between the nervous system and target tissues and organs have led to a breakthrough moment in the field. As decades of research are applied in new ways, innovators are identifying novel neuromodulation approaches that are capable of selectively targeting multiple organs and functions. Bringing more of these solutions to patients will require better clinical translation and improved collaborations between industry, research, and government.
What is neuromodulation?
Neuromodulation is the science of regulating nervous system activity for a therapeutic benefit. Technologies are being developed to directly stimulate the brain, spinal cord, and peripheral nervous system to treat symptoms and diseases, producing life-changing benefits for patients — from relieving pain and preventing seizures to restoring organ function. Neuromodulation technologies, including direct electrical, ultrasound, infrared light, magnetic stimulation, and other modalities, have shown substantial promise in regulating nervous system activity in attempts to target organ function and treat disease.
The opportunity to treat many conditions
Advances in both device technology and scientific understanding of the nervous system have resulted in groundbreaking therapeutic potential, especially when those therapies have predictable and replicable effects on desired organ functions without unintended effects. Emerging research is identifying means to selectively target multiple organ functions by stimulating nerve terminals and sub-branches, through activation of selected nerve fascicles and/or parameterizing of the stimuli. Advancing these solutions will have transformative effects on the field of neuromodulation.
About the Neuromod Prize
The NIH SPARC program aims to help treat conditions by identifying neural targets and accelerating the development of devices that can regulate organ function by modulating autonomic nerve activity. With this Competition, NIH hopes to bridge the gap between early-stage research and clinical application of solutions capable of targeting multiple autonomic functions through selective stimulation of the peripheral nervous system. The Competition seeks to reward and spur the development of proposed solutions that describe a selective neuromodulation approach that can independently regulate two or more desired autonomic functions without unintended effects. The proposed solutions should be capable of completing investigational device exemption (IDE) enabling studies by 2025. Solutions should be tunable, accurate, precise, and demonstrate the ability to quantitatively assess and control multiple on-target and related off-target effects. The proposed solutions must address pressing therapeutic needs, be translatable for immediate or near-term in-human use, enhance or replace existing treatments, and benefit patients and/or practicing clinicians.
Previous Phases: Phase 1
The first phase of the Competition called on all eligible participants, including scientists, engineers, and clinicians, to submit novel concepts and proposals:
Forty-five participants submitted concept papers (maximum 15 pages) describing their proposed therapeutic approach and plan for conducting proof-of-concept studies, rationale for therapeutic use, and potential clinical impact.
Solutions were evaluated against the ability to demonstrate potential for high scientific advancement and clinical impact by selectively targeting multiple autonomic functions to improve outcomes for patients and/or clinicians while mitigating major off-target effects.
Eight quarterfinalists were selected by a judging panel according to Phase 1 evaluation criteria. Quarterfinalists received an equal amount of the Phase 1 prize pool totaling $800,000.
Current Phase: Phase 2
The second phase of the competition is restricted to quarterfinalist winners from Phase 1. To participate, the Phase 1 quarterfinalists must submit data, methods, and results from experiments described in their Phase1 concept papers, as follows:
· Interim milestone:
Report of methods and results demonstrating modulation of a single autonomic function with simultaneous characterization of off-target effects.
· Final milestones:
Report of methods and results demonstrating modulation of multiple autonomic functions with simultaneous characterization of off-target effects.
Either
Documentation that study was determined to be of non-significant risk, or
Plan to address FDA feedback in response to an investigational device exemption (IDE) Pre-Submission.
Interim milestone will be accepted between Thurs Dec 1, 2022 and Friday September 1st, 2023 4:59 p.m. EDT. Each Quarterfinalist teams will have only one opportunity to submit an Interim report.
The Final Phase 2 report must be submitted by 4:59 p.m. EST on Friday December 1st, 2023. Final Phase 2 submissions may be submitted without having previously submitted an Interim report.
All Quarterfinalists who meet interim milestones as verified by a judging panel according to Phase 2 interim evaluation criteria will receive a prize of $100,000 each.
Up to 4 semifinalists will be selected by a judging panel according to Phase 2 final evaluation criteria as winners of Phase 2. Each of those semifinalists will receive equal distribution of the remainder of the $4,000,000 Phase 2 prize pool. All quarterfinalists are eligible for Phase 2 final evaluation regardless of judging panel evaluation of Interim reports.
Awards:- $4,000,000
Deadline:- 01-12-2022
