Notice Number: NOT-RM-17-023
Release Date: October 6, 2017
Office of Strategic Coordination (Common Fund)
Peripheral nerve stimulation to modulate organ function is rapidly developing as a therapeutic approach to a wide range of conditions. Clinical studies to date have yielded both promising successes and puzzling failures, indicating that therapeutic development may be impeded by our limited understanding of human functional peripheral neuroanatomy and its relationship to organ function. To develop this critical translational knowledge, stronger linkages between clinical practice and basic research are needed. The purpose of this RFI is to request broad strategic input from surgeons and interventionalists on the research and program design objectives that will most effectively facilitate the building of these linkages. The input received will be used by the NIH SPARC (Stimulating Peripheral Activity to Relieve Conditions) program and shared with related programs across NIH Institutes and Centers.
This RFI seeks to gather input from surgeons, interventionalists, and other relevant clinicians on partnering to improve the clinical study of neuromodulation devices, specifically in applications involving peripheral or spinal neuromodulation of organ function. Currently, SPARC supports a wide array of anatomical and physiological studies, including some that are intended as proofs of concept for eventual clinical applications. These studies make use of neuromodulation technologies at varying levels of maturity, from those that have FDA clearance or approval for certain uses, to others that are studied only nonclinically. For example, pre-clinical efforts are exploring the use of vagal neuromodulation approaches (IPGs and cuff electrodes) to treat the symptoms of asthma (cervical and pulmonary branch of the vagus) and diabetes (sub-diaphragmatic vagal trunk), spinal cord stimulation for gastroparesis and subcutaneous nerve stimulation for arrhythmia control. Other intervention points, that may be identified by SPARC's anatomical and physiological projects, include sensory and autonomic innervation of the lower urinary tract, colon and adipose tissue. In some cases, neuromodulation devices will be part of a closed-loop platform that includes sensing technologies for measuring organ function, such as gastric EMG recording to inform neuro-electric control of gastric motility and bladder pressure/volume monitoring for neuromodulation therapies targeting the lower urinary tract. SPARC’s technology development projects are also exploring the potential for using non-electrical neuromodulation approaches, like optogenetics and ultrasound.
Some SPARC-funded pre-clinical studies may lead to Investigational Device Exemption (IDE) submissions for a future clinical study. In preparation for these and other future translational partnerships, the SPARC team is seeking clinician perspectives on any and all of the following topics, or any other topic relevant to the above statement of purpose:
Engineering considerations/device requirements:
Research rigor, reproducibility, and safety:
We encourage submissions by any method convenient to the respondent. Written comments may be emailed to SPARC_TPNI@mail.nih.gov. Audio files such as smartphone or dictaphone voice memos may be attached and emailed to the same address. Voice mail messages may be left to Dr. Siavash Vaziri at 301-594-8921. Teleconferences with the SPARC team to convey information may be requested at http://nihsparc.setmore.com.
To ensure consideration, responses must be communicated by December 1st, 2017. NIH will confirm written response submission, but respondents will not receive individualized feedback.
Responses to this RFI are voluntary. Please do not include any proprietary, classified, confidential, or sensitive information in your response. The NIH will use the information submitted in response to this RFI at its discretion. The collected information will be reviewed by NIH staff, may appear in reports, and may be shared publicly on an NIH website. However, any information shared publicly will be de-identified and will not be attributed to any individual.
The Government reserves the right to use any non-proprietary technical information in summaries of the state of the science, and any resultant solicitation(s). The NIH may use the information gathered by this RFI to inform the development of future funding opportunity announcements.
This RFI is for informational and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States (US) Government or the NIH to provide support for any ideas submitted in response to it. Please note that the US Government will not pay for the preparation of any information submitted, or for its use of that information.
Please direct all inquiries to:
Siavash Vaziri, Ph.D.
National Center for Advancing Translational Sciences (NCATS)