Note: All links and resources are provided for informational purposes only.
Details about the NIH SPARC program
Open-source repository of curated datasets, maps of nerve-organ interactions, experimental protocols, and computational studies.
Neuromod Prize Solver Community
Success in all phases of the Neuromod Prize will require a breadth of expertise, and participants are encouraged to consider collaborating with each other or expanding their existing teams. If you are interested in joining the Neuromod Prize solver community, please fill out the short on this page.
Present and emerging methods
Informational resources on advancements and barriers in the field
Resources including multidisciplinary discussions and collaborations that stimulate further progress in the area of bioelectronic medicine.
Neuromodulation: Present and Emerging Methods
A paper reviewing the state-of-the-art in ENS, as well as alternative neuromodulation techniques; presents the operational concepts, technical implementation, and limitations in order to inform system design choices.
International Neuromodulation Society: Emerging Therapies and Diagnostic Tools
News briefs from the International Neuromodulation Society.
The Rise of Bioelectric Medicine Sparks Interest Among Researchers, Patients, and Industry
An article summarizing barriers and opportunities in the rise of bioelectronic medicine.
Bioelectronic Medicine: Engineering Advances, Physiological Insights, and Translational Applications
Collection of articles on the advances in bioelectronic medicine.
Websites and platforms to support development
SPARC Protocols.io Workspace
A secure platform for developing and sharing reproducible methods.
An open-source tool providing access to supercomputers for cloud computing and neuroscience research.
An open-source, object-oriented neural simulation toolbox optimized for high-performance, multicore, multinode computer architectures.
A simulation platform that enables users to create, access, tune, and run models or computational algorithms through a web-based interface.
Regulatory resources for neuromodulation therapies
Regulatory Overview for Neurological Devices
FDA guidance on regulatory pathways for different neurological devices, including invasive neuromodulation devices.
Investigational Device Exemption
FDA overview of the IDE approval process and best practices, including resources for submitting an application.
Best Practices for Navigating the IDE Pre-Submission Process with FDA
Webinar for the BRAIN initiative providing resources and guidance on the IDE pre-submission process.
Center for Devices and Radiological Health
FDA agency assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
How to Study and Market Your Device
FDA guidance on the four steps of bringing a device to market.
Regulatory Overview for Developers and Sponsors of Neurological Devices
FDA webinar providing an introduction to the De Novo pathway for regulatory approval.
Target performance considerations
Participants are asked to consider and address target performance considerations in their submissions. In Phase 1, the metrics serve as general guidelines for successful targeting through neuromodulation, and they may be adjusted or specified as quantitative metrics in future phases.
For any and all target indications identified, describe how the proposed approach to stimulation achieves:
- Tunability of both the stimulation parameters (e.g., pulse width) and protocols (e.g., current steering).
- Accuracy of stimulation outcomes to a generally accepted standard of error for the target indication(s).
- Precision of stimulation outcomes within a generally accepted range of variability.
Provide a quantitative assessment of both on-target and off-target events that occur within seconds to minutes of stimulation. For example:
- Describe in detail the biomarker(s) that will be measured to determine the outcomes of stimulation on target autonomic functions. Identified biomarkers must include those which are regulated by the same nerve being modulated.
- Explain the level of confidence in the biomarker(s) to reliably correlate with the intended outcomes, for example: no more than X% change in biomarker(s) during specified time frame during and after stimulation.
- Assess the ability to independently control autonomic functions, for example: selectively adjust Function A by X% without change in Function B, and adjust Function B by X% without change in Function A.
A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions. Biomarkers may include molecular, histologic, radiographic, or physiologic characteristics.
If a solution stimulates the pudendal nerve, it will be insufficient to only monitor changes in heart rate and/or respiratory rate, considering that the pudendal nerve does not innervate the heart or lungs. Instead, such a solution would need to monitor, and mitigate, unwanted outcomes in the anorectal sphincter, if it is targeting the urethral sphincter.
How to enter
REGISTER YOUR TEAM
Set up an account so you can submit as soon as your concept paper is ready.
READ THE DETAILS
ENTER YOUR SUBMISSION
Log in to your account to upload your concept paper in PDF format and fill out additional submission details by April 28.