Request for Information (RFI): Seeking Input from Surgeons and Interventionalists on Improving the Clinical Study and Use of New and Established Peripheral Neuromodulation Devices

Notice Number: NOT-RM-17-023

Key Dates
Release Date:  October 6, 2017

Related Announcements
NOT-RM-17-015

Issued by
Office of Strategic Coordination (Common Fund)

Purpose

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.

Background

 

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.
Information Requested

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:

Surgical planning:

  • Shortcomings of existing nerve visualization tools (non-invasive or invasive).
  • Ways in which research data might be used in treatment planning, particularly for specialties in which neuromodulation options are new or emerging.
  • Desirable features of an online atlas of the human PNS.

 

Surgical access:

  • Needs for new surgical approaches (open surgery, laparoscopic, endovascular, injectable, vascular, or other), particularly for accessing clinically relevant nerve branches located close to organs, which may be smaller or more difficult to identify.
  • Shortcomings of existing surgical tools.

 

Engineering considerations/device requirements:

  • Clinical considerations impacting device design requirements (e.g. anchor positioning and suturing considerations for different leads).
  • Shortcomings of existing attachment methods
  • Physical design and material needs for neuromodulation technology interfacing with different types of neural tissue (nerves, ganglia, or plexi).
  • Suitability of size and shape of current devices

 

Data collection:

  • The potential use of clinical settings to collect human physiology data to enhance our understanding of the functional relationship between neural signals and organ responses at points of intervention. The potential of such data to help translate and optimize the functional maps derived from animal models for prediction of clinical efficacy.
  • Availability, effectiveness, and short-comings of clinical devices with expanded research capabilities for obtaining data to address functional neuroanatomy (e.g. state of recording capabilities of clinical-grade neurostimulators).
  • Privacy considerations regarding the sharing of human recording data with the scientific community.
  • Opportunities and challenges in acute clinical settings to collect human peripheral nerve recordings (e.g. during implantation surgeries or replacement of pulse generators).

 

Research rigor, reproducibility, and safety:

  • Methods for improving the rigor and reproducibility of small, device-centered clinical studies (e.g. sample sizes, shams, controls, efficacy metrics and how to assess go/no-go criteria in small study populations with idiosyncratic conditions).
  • Special considerations in neuromodulation device-based studies with respect to study design and safety monitoring.
  • Common pitfalls encountered in clinical research involving current neuromodulation devices (implantable or non-invasive; e.g. vagal nerve stimulators).
  • Regulatory and patient recruitment challenges involved when translating basic research into clinical device studies.
  • Ethical challenges and implications (e.g. liability, long-term patient care considerations extending beyond the study period, vulnerable populations, sham control).

 

Partnering:

  • Effective ways to engage the surgical community to participate in clinical research studies with neuromodulation devices.
  • New therapeutic opportunities that can be explored using existing clinical neuromodulation technology.
  • The training needs of existing and emerging medical specialties in the field of peripheral neuromodulation.
  • Motivations for or against conducting device-centered research.
  • Challenges in establishing successful collaborations with industry partners to conduct device-based clinical studies.

 

How to Submit a Response

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.

Inquiries

Please direct all inquiries to:

Siavash Vaziri, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8921
Email: SPARC_TPNI@mail.nih.gov