Submissions were evaluated based upon the following judging criteria. Applicants were encouraged to review these criteria in detail and tailor their submissions accordingly.
When evaluating submissions, judges assigned each submission 1 to 5 (5 being the highest; 1 being the lowest) points for each of the five evaluation criteria, for a maximum of 25 points.
Phase 1 criteria
Extent to which the concept could achieve or exceed the necessary requirements for selectively treating two or more target indication(s) with a high degree of tunability, accuracy, and precision.
Extent to which the concept addresses potential adverse effects of its proposed approach by identifying clinically relevant risks and monitoring off-target outcomes related to the neural target.
Extent to which the concept indicates readiness for proof-of-concept study design, identifies the barriers to clinical translation, and articulates next steps to bridge gaps.
Potential for the concept to advance the field of neuromodulation by deepening our understanding of underlying mechanisms and yielding additional insight into targeting specificity.
Extent to which the proposed solution addresses pressing therapeutic need(s), is translatable and enhances or replaces existing treatments, and benefits patients and/or practicing clinicians.
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.