A Message from the President
Dear INS members and friends,
Early 2016 found me looking both at our past and at our future. In February, we lost two leading figures who had had long impact in medical devices or pain medicine. First, the bioengineering industrialist and philanthropist Alfred E. Mann died Feb. 25 at age 90. Then on Feb. 27 chronic pain expert Dr. P. Prithvi Raj, a global advocate for pain management, died at age 84.
In addition to my gratitude for their contributions, I also look ahead with pride to upcoming neuromodulation training opportunities being arranged through our chapters. More than one INS chapter will offer hands-on workshops during a pre-conference session at their annual scientific meetings. Read more about chapter activities in this issue.
About Al Mann and Dr. Raj, I would like to share a few details of their influence and impact.
Al Mann was an inventive, highly effective, and visionary trailblazer in the broad field of neuromodulation. With his tireless pursuit of better technologies to help relieve chronic conditions -- from heart disease and hearing impairment to blindness -- he helped realize part of the promise posed by the ability to selectively modulate components of the nervous system.
Many of you may remember his keynote speech at the 6th INS Congress in Madrid in 2003, where he addressed how to bring a device to the marketplace.
I believe we are indebted to him for providing not only new products, but also for his vision and commitment to improve the lives of patients. Besides founding 17 companies, he was a philanthropist who established the Alfred E. Mann Foundation in 1985 in Valencia, CA to help translate basic biomedical research into products to address unmet, or poorly met, needs.
Dr. P. Prithvi Raj was an expert in pain medicine and regional anesthesiology who influenced subsequent generations of pain medicine specialists. Many of the specialists he influenced hold highly productive leadership positions today. Quite a number are active in the INS. As a citizen of the world, he worked in anesthesiology in Norway, England, Texas, California, Ohio and Georgia. He also was a founding member of the Texas Pain Society and past president of the World Institute of Pain, later going on to chair its foundation. Dr. Raj was professor of anesthesiology and associate director of the International Pain Institute at Texas Tech University Health Sciences Center. He founded and served at the University of Cincinnati Pain Clinic from 1979 to 1986. Throughout his retirement, he continued to travel and lecture, sharing his knowledge and passion for the field.
In closing, I want to wish you all the best, and express appreciation for all your efforts in our great journey together in furthering neuromodulation therapy.
Timothy Deer, MD
President of INS
Progress on Congress Proposals
Many thanks to everyone who responded to the International Neuromodulation Society (INS) Executive Committee’s invitation for proposals regarding development of the INS congresses in 2017 and 2019.
For the INS 13th World Congress, “Neuromodulation: Technology Changing Lives,” which takes place in Edinburgh, Scotland on May 27 - June 1, 2017, the Biennial Congress Committee will consider the submitted proposals for lecture topics and speakers for plenary and breakout sessions. The deadline to submit proposals is May 1, 2016.
Meanwhile, regarding the venue of the 14th World Congress in 2019, INS appreciates the recommendations that members sent.
With active participation of members such as this, the society and its programs continue to thrive and meet the needs of the broad neuromodulation community.
We invite your plenary and breakout lecture proposals by May 1, 2016 on the full spectrum of neuromodulation science and research, to ensure that our delegates’ educational needs are thoroughly met.
The biennial congress committee will consider basic science, clinical studies and biomedical engineering presentations on neuromodulation for:
Brain disorders, including epilepsy, Parkinson's disease, dystonia, traumatic brain injury, stroke, psychiatric disorders, etc.;
Chronic pain conditions that are underserved;
Cardiovascular disorders, including heart failure, angina, and peripheral vascular disease;
Systemic disease;
Pelvic organ motility disorders; and
Neurorehabilitation; as well as
Mechanisms of action of neuromodulation; and
Non- and less-invasive neurostimulation.
Clinical Trials and the Establishment of Clinical Utility
With an eye toward gathering clinical utility data that he has found to be of interest to European health authorities, Swiss Neuromodulation Society co-founder Eric Buchser, MD, took note recently of a review concerning head-to-head clinical trials of drugs and other treatments that was published in the Journal of Clinical Epidemiology in 2015:
Flacco ME, Manzoli L, Boccia S, Capasso L, Aleksovska K, Rosso A, Scaioli G, De Vito C, Siliquini R, Villari P, Ioannidis JP. Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor. J Clin Epidemiol. 2015 Jul;68(7):811-20. doi: 10.1016/j.jclinepi.2014.12.016. Epub 2015 Feb 7. Review. PubMed PMID: 25748073.
The lead author, Maria Elena Flacco, is a medical resident in Hygiene, Epidemiology and Public Health at the University of Chieti, Italy, and participates in a regional cancer registry working group. The senior author, John P. A. Ioannidis, is a professor of Medicine and of Health Research and Policy at Stanford University School of Medicine and a professor of Statistics at Stanford’s School of Humanities and Sciences. Trained in internal medicine, he has co-authored a number of papers that champion taking a measured view of new evidence about therapies and treatments under development.
The authors examined a random sample of one-fourth of the head-to-head comparative clinical trials with at least 100 patients that were reported in PubMed in 2011. Although the authors’ literature-search terms included medical devices, the final sample of 319 studies only comprised pharmaceuticals (90.2%) and biologics (9.8%).
Still, Prof. Buchser found food for thought in the paper about the development of evidence-based medicine.
“The days of the randomized placebo-controlled clinical trials in spinal cord stimulation are largely over,” he said. “We know that the therapy is effective and we are not really after efficacy anymore, but much more after clinical utility.” Particularly in his part of Europe, he said, this is important to health authorities.
International Neuromodulation Society (INS) Secretary Marc Russo, MD, an INS newsletter reviewer and co-founder of the Neuromodulation Society of Australia and New Zealand, also offered a perspective.
“I agree with Dr. Buchser that the need to establish that spinal cord stimulation (SCS) is effective against placebo treatment is already obviated by the amount of trial data showing efficacy,” he commented. “I believe there is still usefulness in randomized controlled trials against comparator or historical treatments to inform treatment decisions especially in subgroups (SCS versus spinal fusion in the non-operated lower-back-pain patient for example).
“This representative snapshot of large randomized controlled trials published five years ago (and representing a clinical trial design decision probably taken some 10 years ago) shows higher quality scores for trials that are funded by industry. They were larger, more likely registered and higher citation impact. This is not too surprising given the funding limitations non-industry groups are subject to.
“An impressive 43% of large trials (>100 subjects) were still conducted with no industry funding.”
In terms of clinical trial design, of the research studies examined in the paper, those with only nonprofit funding used a noninferiority/equivalence design 24.1% of the time. The industry-sponsored trials in the study used a noninferiority/equivalence design slightly more often, 31.3% of the time.
In the study, 57 trials had a noninferiority/equivalence design; 96.5% of those had favorable results.
“As many industry-funded trials were comparing a company's older drug with their newer one in the same indication there was a preponderance of noninferiority design as the trial type,” Dr. Russo commented. “Noninferiority had a higher chance of being associated with a positive finding for the treatment outcome. This is also not surprising either given the lesser challenge of showing equivalence or non-inferiority to a comparator treatment than a superiority design. In an ideal world there would be a higher bar set by Industry to failure but commercial considerations on the necessary minimum for registration of the treatment may be coming in to play.”
The authors calculated that the odds of a noninferiority/equivalence design clinical trial having a favorable result was 3.2. Overall, with all trial designs included, the odds of an industry-sponsored clinical trial having favorable results was 2.8.
In explaining those odds, the authors point out that companies contemplating large-scale clinical studies would base any undertaking upon results from smaller, earlier phase I or II studies. They also reason that noninferiority designs can require fewer participants, be less costly to conduct, and may not require as large a treatment effect.
Overall, of the 182 head-to-head trials of various designs funded by for-profit companies, 83% had positive results, compared to 59% of the 87 clinical trials in the study that were funded solely by nonprofits. (Another 50 clinical trials in the sample did not report funding sources. Of those, 70% had positive results.)
Choosing between a superiority or noninferiority/equivalence design is a particular challenge posed by head-to-head trials, the authors say. They call for the selection of a clinical trial design to be primarily made to “inform important questions,” and recommend that more large trials of comparative effectiveness and safety be carried out “under the control of nonprofit entities.”
“Whether industry-funded or not it is always likely that noninferiority design will be associated with a higher rate of positive outcomes than a superiority design by its very nature,” Dr. Russo remarked. “The perennial requirements of research being applicable in the real world, defining population boundaries that it is appropriate for, documenting long-term outcomes, assessing cost-effectiveness – these are the challenges that we face now and into the future.”
French Chapter of the International Neuromodulation Society Revitalizes
The French chapter of the International Neuromodulation Society, the Société Française de NeuroModulation (SFNM), has been reinvigorated through the efforts of its new chapter president, Prof. Philippe Rigoard, MD, PhD.
The reformulated group met for the first time in November 2015, and now has over 50 members. The attendees identified three research topics for the network to develop over 2016-2018:
- Pregnancy and spinal cord stimulation
- Physiotherapy for patients who have implanted devices
- The collection of independent, prospective data and long-term follow-up of failed neurostimulation patients and "saved" patients
The November meeting also included member registration and a working session on occipital nerve stimulation.
The chapter discussed plans to hold two trainings a year for medical residents and implanters, in the east and west sides of the country (Colmar and Nantes).
The new SFNM president, Prof. Rigoard, is senior surgeon and coordinator of the Spine & Neuromodulation Unit within the Neurosurgical Department at the Poitiers University Hospital in France. He is also an Honorary Consultant in the pain clinic of Guy's and St Thomas NHS Foundation Trust hospital in London, UK; an Anatomy Conference reader at the Human Morphology Institute, Faculty of Medicine of the University of Poitiers; a researcher at Inserm CIC (Clinical Investigation Center) 802; and the research program director of the N3Lab (Neuromodulation & Neural Networks Lab) in Poitiers.
The Spanish Chapter of the International Neuromodulation Society
In Spain, Prof. Antonio Pajuelo, MD, called an initial meeting March 12 to reformulate the Spanish Chapter of the INS, the Sociedad Española de Neuromodulación. Prof. Pajuelo is Head of the Pain Unit at the University Hospital Virgen del Rocío in Seville and professor of the Faculty of Medicine of the University of Seville.
The chapter has established a web presence at:
http://www.neuromodulation.es
The objective of this new stage is to give continuity to the work that has been done to date by Dr. David Abejón in this national chapter.
"The participation and collaboration of all who work in this exciting field is absolutely essential if we are to achieve our goals and objectives," Dr. Pajuelo said.
At the inaugural meeting, the group discussed re-invigoration of the chapter, areas of focus regarding development of neuromodulation, and a calendar of activities for the year.
Please stay tuned for details regarding a meeting in Seville in September.
Joint Neural Interfaces Conference - North American Neuromodulation Society Meeting in June
The Neural Interfaces Conference (NIC) began as a meeting about neural prosthetics in the 1970s among contractors of the National Institutes of Health. The NIC's 42nd meeting will be a joint meeting with the North American Neuromodulation Society (NANS), June 26-29, 2016 in Baltimore, MD.
The NANS2-(NIC) conference focuses on research and development of implantable medical devices and techniques. The meeting will also include a clinical workshop to demonstrate designing clinical trials and testing.
Agenda Items:
- Navigating the Changing Landscape of Spinal Cord Stimulation
- Choosing the Right Modality for Your Patient
- Clinical Evidence behind HF10, Burst, DRG
- Where Neuromodulation fits into a surgical practice
Educational Offerings:
- Cadaver Workshops
- Neuromodulation in Your Practice
- Joint Collaborations with Scientists in the Lab
A travel grant from the National Institutes of Health is also open to undergraduate students, pre-doctoral graduate students, and postdoctoral trainees who submit scientific abstracts and belong to groups that are underrepresented in the engineering population.
The organizers invite abstract submissions by May 1 from Investigators of all levels. Abstracts must represent original scientific research or non-commercial content related to clinical practice.
Abstract topics:
Auditory Prosthesis
Bioelectronic Medicine
Brain Computer/Machine Interface
Clinical Neuromodulation
Deep Brain Stimulation
Electrodes
Novel Neural Interfaces
Materials and Devices
Models and Stimulation Paradigms
Nanoscale Interfaces
Neural Prosthesis
Neural Signal Processing
Neuroplasticity and rehabilitation
Optical Stimulation/Recording
Peripheral Nerve Interfaces
Sensory Motor Integration
Visual Prosthesis
Wireless Systems
Medical Bionics Summit 2016 Comes to Washington, D.C. in April
The Medical Bionics Summit 2016 takes place April 6 - 7 in Washington, D.C., and is dedicated to the design, development and commercialization of medical devices that adapt and augment the human body. This event is specifically designed to find collaborative solutions to shared challenges faced across the different technologies including advanced prosthetics, wearable robotics, prosthetic organs, neural implants, bioelectronics and neuromodulation.
The International Neuromodulation Society (INS) and the Medical Bionics Summit both strive for improved technology to improve patient lives. The INS has not endorsed the Medical Bionics Summit, but applauds the efforts of the summit to advance the field.
Neuromodulation: The Science Meeting to Take Place in May
The meeting Neuromodulation: The Science takes place May 25 - 29, 2016 in San Francisco. The meeting explores the scientific history, current state, and future of the sub-specialties that make up this field, and are evolving it now.
The meeting combines and expands two earlier meetings presented in 2014 by Neurovations Education: Mechanisms of Action of Neuromodulation, and Targeted Drug Delivery. The May 2016 meeting is designed by Elliot Krames, MD, past president of the International Neuromodulation Society (INS) and founding editor of Neuromodulation: Technology at the Neural Interface; and Neurovations CEO Eric Grigsby, MD; with the support of meeting co-chair Peter Staats, MD, past president of the North American Neuromodulation Society (NANS).
Topics:
Functional Electronic Medicine
Gastric Electrical Stimulation
Bioengineering
Deep Brain Stimulation
Mechanisms of Action of Spinal Cord Stimulation
Epilepsy
Optogenetics
The Brain-Machine Interface
Targeted Therapeutic Delivery
Bioelectronic Medicine
Spinal Cord Stimulation.
Funding Opportunity for Preclinical Testing of New Indications for Existing Devices
The NIH Common Fund Program on Stimulating Peripheral Activity to Relieve Conditions (SPARC) has released a new funding opportunity announcement (FOA). This is the first FOA released under the Use of Existing Market-Approved Technology for New Market Indications research component of SPARC. It solicits proposals for pre-clinical testing of existing neuromodulation devices, from SPARC’s industry partners, in support of new market indications. These pre-clinical studies are expected to generate the necessary safety and efficacy evidence to enable an Investigational Device Exemption (IDE) submission for a future pilot clinical study. Information about the device(s) and support provided by SPARC’s industry partners is available on SPARC’s Device Portal website.
Stimulating Peripheral Activity to Relieve Conditions (SPARC): Pre-clinical Development of Existing Market-approved Devices to Support New Market Indications (U18) (RFA-RM-16-009)
Letter of Intent due: April 2, 2016
Application due: May 2, 2016
SPARC is uniquely positioned to serve as a community resource that provides the broader public and private research communities with the scientific foundation necessary to pilot new and/or improved closed-loop neuromodulation devices and stimulation protocols to treat diseases and conditions through precise neural control of peripheral end-organ system function. The Use of Existing Market-Approved Technology for New Market Indications research component of SPARC encourages development of partnerships between device manufacturers and NIH-supported investigators to explore the feasibility of utilizing existing neuromodulation devices for new therapeutic applications. Template agreement documents have been prepared to facilitate partnerships between companies and clinical investigators. These partnerships will allow investigators to have access to existing neuromodulation technology to perform pre-clinical development (focus of the current FOA) towards conducting pilot clinical studies (the focus of the next phase of this component of SPARC). The long-term expectation of this component of SPARC is that proof-of-principle demonstrations in humans will lead to the larger clinical trials required for taking these ideas to market.
Please contact [email protected] if you have any questions regarding these funding opportunities. In addition, please feel free to share this announcement with your colleagues.
WIKISTIM and Data Utility
Future enhancements envisioned for WIKISTIM -- the independent, collaborative database of primary neuromodulation research data -- include linking to explanations of preferred uses of study designs and outcome criteria.
This material is intended to support WIKISTIM's mission of encouraging careful data collection and use, says executive director Jane Shipley. When planning and reporting a study, authors are also encouraged to consider the structure of the free resource's datasheets. These are designed to facilitate convenient data abstraction and sharing, and datasheet schemes are customized for each stimulation target.
In June, WIKISTIM will present a talk about maximizing rigorous and robust methods of data-gathering at the North American Neuromodulation Society and Neural Interfaces Conference Joint Meeting in Baltimore, MD. A key goal of presenting a better way to conduct studies and publish data, Shipley says, is to make a sound evidence base regarding neuromodulation more widely accessible. WIKISTIM also seeks to constructively influence how published results are analyzed in relation to other findings. She commented that the neural interface community is uniquely positioned to contribute to the WIKISTIM model and to benefit from the nearly 5,000 citations already included in the database.
WIKISTIM encourages people to alert others to this resource, to which all are welcome to submit extractions of published primary research data. People are also welcome to notify the organizers of any reports with primary neuromodulation research data that have not already been cited.
Abstracts Due June 25 for Canadian Neuromodulation Society Annual Meeting
The Canadian Neuromodulation Society (CNS) has issued a call for abstracts for its 9th annual scientific meeting, which takes place Sept. 30 - Oct. 2 in Regina, Saskatchewan, Canada to honor the late Regina neurosurgeon Krishna Kumar, MD, founding president of the CNS.
Abstracts are due June 25, 2016. For instructions, please see the CNS website, http://www.neuromodulation.ca/.
Training Opportunities and Hand-on Workshops
There are a number of cadaver workshops and related activities on the horizon for 2016. Please watch the International Neuromodulation Society (INS) Events calendar for further details. There, you will also see listings of all chapters' annual scientific meetings, as they are announced.
Upcoming hands-on training plans from INS chapters in 2016 include:
- From April 28 - 30, an international training program will take place under the auspices of the Argentinean Neuromodulation Society (Sociedad Argentina de Neuromodulación -
SANE), the Federación Latinoamericana de Asociaciones para el Estudio del Dolor (FEDELAT), the Sociedad Científica Argentina (SCA), CENIT Foundation, and the Faculty of Medicine of the University of Buenos Aires. The theoretical and practical course will have a cadaver hands-on training program and programmed surgeries. Its director will be INS Executive Officer and SANE Past President Fabián Piedimonte, MD. One of his confirmed assistants is David Abejón, MD, PhD, past president of the Spanish INS chapter.
- The NANS2-NIC meeting in Baltimore, MD June 25 - 29 includes a cadaver workshop. (See the separate article about this joint meeting involving the this INS chapter, the North American Neuromodulation Society, NANS.)
- A cadaver workshop is planned during the 2016 Interim Meeting of the International Neuromodulation Society and 7th Annual meeting of the Chinese Neuromodulation Society, "The Application of Neuromodulation," Aug. 25 - 28 in Chengdu, China.
- The Italian chapter, Capitolo Italiano INS, will offer a practice session / cadaver course to approximately 30 participants who have passed a preceding six-hour theoretical course. The course takes place during the national congress Sept. 22 - 24 in Naples, Italy. The chapter first offered such a training in 2013, and again in 2014.
- Prior to its annual scientific meeting, the German chapter, Deutsche Gesellschaft für Neuromodulation (DGNM), plans a spinal cord stimulation workshop on Thursday, Nov. 10 in Düsseldorf.
- The Turkey chapter anticipates organizing a cadaver workshop in 2016.
Other educational or training events have also been under discussion for the near future, or have just occurred.
For instance, the French chapter, Societé Française de Neuromodulation (SFNM), anticipates holding two national trainings per year (In Nantes in the east, and Colmar in the west) for residents and implanters. For 2017, SFNM has initiated discussions about organizing an international training symposium in the IRCAD surgical simulation lab at University Hospital of Strasbourg.
In March 2016, a two-year theoretical and practical course on functional neurosurgery and neuromodulation began at the Faculty of Medicine of the University of Buenos Aires, which was organized by SANE President Juan Carlos Andreani, MD and Past President Dr. Piedimonte. And in Perth, during the annual scientific meeting of the Neuromodulation Society of Australia and New Zealand (NSANZ), breakout sessions March 13 included a panel on comparative contemporary practice "What would I use when . . .", a new implanters masterclass, and case presentations.
Finally, the Brazilian chapter, Sociedade Brasileira Neuromodulação (SBNM), has added information translated into Portuguese for patients from the INS website.
More chapter-meeting announcements can be found on the INS Events page.
The International Neuromodulation Society in Social Media
At the start of 2016, the number of followers of the International Neuromodulation Society's Facebook page surpassed 1,000.
Meanwhile, discussion has been active on the members-only peer-consultation email forum hosted through Google Groups, INSForum. The latest question involved the case of a spinal cord stimulation recipient who developed Raynaud's syndrome.
|
