Neuromodulation News: August 2020

President's Message l New Journal Impact Factor  l INS 15th World Congress l Call for Abstracts for the INS 15th World Congress l Directors-at-Large Elected l 2nd Joint Congress of the INS European Chapters l Neuromodulation INS Centers of Excellence Surveys l PACC Update Survey Completed l New Monthly Webinars l Virtual Journal Club Starts l INS 14th World Congress Presentations in Members Only Section l "Keep Me Logged In" Function l Ways to Get Involved

A Message from the President

Neuromodulation During the Pandemic

During these difficult times, it is important to recognize just how profound the impact of COVID has been upon neuromodulation worldwide and upon us as doctors and our patients who are in tremendous need of our help. In the United States alone, we have surpassed 3 million cases of COVID-19 and nearly 150,000 deaths. Worldwide, we have been plagued by nearly 15 million cases and over 600,000 deaths. These deaths are of our friends, our patients, our colleagues and our families; no one I know has been free of the impact of COVID on their lives.

I must first congratulate and honor all of our members are currently attempting to deal with this crisis on an emergency level. So many of our members as anesthesiologists are dealing directly with the crisis in intensive care units in clinics and in emergency rooms. They have put themselves at personal risk in order to help our society, and those people should be recognized for their tremendous contributions.

I would also like to recognize the work of several neuromodulation researchers whose work has led to neuromodulation therapies with potential effectiveness against COVID-19 and its clinical manifestations. While this seems almost incredible, we know that for many years Kevin Tracy and his group have been examining the effect of vagal nerve stimulation on inflammation for rheumatoid arthritis and other disorders. There is a large volume of research demonstrating that vagal nerve stimulation (VNS) can be highly effective as an immunosuppressive. Peter Staats and his group have done high quality work demonstrating the effect of transcutaneous, non-invasive vagus nerve stimulation for disorders including asthma and bronchospasm. They have demonstrated that vagus nerve stimulation can significantly inhibit pulmonary reactive inflammatory processes. We know that COVID-19 results from the coronavirus infection, the most lethal effect of which is a direct effect on the lungs. The virus triggers an inflammatory immunologic storm that then profoundly compromises pulmonary function. Thus, Staats and coworkers have proposed that non-invasive VNS may help to decrease inflammation, block the pathological immunologic storm and protect the lungs in the setting of COVID-19. There is anecdotal experience that suggests that vagus nerve stimulation may be effective in helping to prevent people with COVID from developing these more horrific pulmonary complications. While this work is very preliminary, it has led to FDA approval of the use of non-invasive VNS for the treatment of COVID-19.

All of our more traditional neuromodulation therapies, however, become much less useful in the setting of the current pandemic. Due to issues of resource allocation and potential infectious risk to health care workers and patients, many of us have been prevented from performing neuromodulation procedures which are deemed as “non-emergent” or “elective”. As responsible practitioners, we need to look at the various phases of COVID infection to determine how and when it is best to reengage our practices and to reengage our patients so that we may help them with these increasingly effective technologies. I refer neuromodulators worldwide to access the COVID-19 page on the INS website for detailed guidance.

The first thing that becomes important is to evaluate the local impact of COVID which is very different around the world and even within the United States. Where I live, for example, in Florida, the rate of infection is increasing rapidly and we are seeing record numbers of infections every day. We have seen greater than 10,000 new infections each day for the past week; this is larger than at any time during the COVID-19 pandemic. Attempts at controlling the spread of the virus have met with failure either due to poor leadership or an unwillingness on the part of the Floridian people to endorse important public health measures. I am deeply embarrassed by the fact that social welfare and public health are so low in the hierarchy of issues important to this and area other areas of the United States. Certainly other areas of the world, including South Korea, Italy, Spain, and Germany, have been much more successful at attempting to give clear guidance to their citizens and for citizens to consider the science and work as a group together to help overcome this illness by using recommended preventative measures. I don't fully understand why it has been so difficult in the United States. Even public discussion that has led to consensus in other countries seems to missing be in the United States; where cases continue to rise, emergency rooms and intensive care unit beds continue to be filled and the death rate continues to grow. It is humbling and humiliating to me at the same time to be speaking to you as your president and to recognize that my country is trailing behind most of yours in terms of our public health efforts. That being said as we are able to start opening up in other parts of the world, the question remains as to how we do it safely for us, for our patients and for our societies.

I believe the best work that's been done on this so far involves a cooperative group from the UK and INS members including Sam Eldabe, James Fitzgerald, Simon Thompson Ganesan Baranidharan, Ashish Gulve, John Hughes, Girish Vajramani, Chirag Patel, and Sarah Love-Jones. They identified that 92% of patients in the UK would agree to COVID testing, self-isolation and isolation procedures during pre- and post- operative care in order to speed up their access to neuromodulation therapies. Thus, it appears that there is a willingness on the part of the patients to undergo these procedures; this leaves us as their caregivers and caretakers to be able to instruct them in terms of what is safe and what is not. I follow with some of the cooperative group’s recommendations. We must first look at our local environment to determine just how bad is it. Are our case numbers falling off, are there sufficient intensive care unit beds available for people who are sick with COVID-19, is there sufficient bandwidth to treat these patients safely. In some areas of the United States this is clearly the case whereas in others, in fact 32 of our 50 states, have identified increasing numbers of cases within the last several days. While it is a minority, there are some areas in the United States that are seeing a decrease in the number of cases and have the bandwidth to allow us to safely proceed with non-emergent neuromodulation procedures.

Second, we need to prioritize our patients and procedures so that we can identify which are truly critical versus those that are actually elective. A patient with cancer pain does not have the time to wait a year for a COVID-19 vaccine; they need help now. Patients receiving intrathecal drug therapy particularly with opioids or with Baclofen are at risk of acute withdrawal and subsequent severe withdrawal effects. Those patients needing pump refills and those patients requiring re-implantation of expired pumps due to the end of battery life or problems with the catheters or pumps themselves do not have the luxury of waiting. There are also patients who are somewhat less acute but still require more than purely elective therapy. For example, consider patients who have been getting good therapy whose IPGs have died or whose electrodes have moved. Having experienced significant pain relief, they are desperate to regain that relief and are somewhat higher on the ladder than other patients. Patients scheduled for routine trials of therapy or implants need to be considered on a case by case basis to determine whether or not their need is acute enough and our bandwidth is large enough that we can offer them a safe and effective procedure without limiting access to care for coronavirus infected patients.

The group in the UK has recommended robust multidisciplinary evaluation of all potential new patients. Decision by more than one physician and an interdisciplinary group confirms the objective need to go ahead and addresses issues of bias such as personal gain or simple personal preference. This allows us to align our decisions with both the patient and our public health needs. The UK group has gone so far as to wonder if certain patients should not have a trial at all. To minimize bandwidth demands on our health care systems, they suggest that the response on the table during a trial may be sufficient proceed immediately with IPG implantation, avoiding a second surgery. In some countries (e.g. USA and Belgium) this is not possible due to reimbursement regulations. In others, particularly with the real question as to whether or not trials are truly predictive of long-term success, it may well make good sense to eliminate a second surgery and go ahead with a permanent implant based upon the on the table trial response.

It goes without saying that routine testing of patients scheduled for surgery is mandatory and particularly for those getting general anesthesia. The risk of transmission is not insignificant; we must therefore also educate our patients and truly inform them about their risks and about populations at risk – patients such as those over 60 years old, those who are diabetic or have hypertension or other cardiovascular disease. All have a demonstrated significantly higher risk of not only catching but dying from COVID. Again, we must inform our patients of these risks and then again only if they understand and agree to these risks should we go ahead. Local anesthesia or monitored anesthesia care may well be preferable to general anesthesia because of the particular risk of spread that is greater with intubation. We should discuss this with our patients and our treating anesthesiologists to determine what is best for the patient and other healthcare providers.

We also need to adjust our surgical schedules to allow more time in the operating room to make sure that we mitigate the risk of exposure for ourselves, our operating room personnel and our patients by obeying certain separation distances and ensuring that proper cleaning is performed between cases. We should attempt to do our procedures out of the hospital in the same day surgery setting. Our patients going to the hospital are placed at greater risk due to proximity to coronavirus infected patients. Furthermore hospitals need the beds not for elective patients but to provide the kind of critical care that coronavirus infected patients require.

We should also ensure that anyone who tests positive for coronavirus infection or has active COVID-19 symptoms has their surgery delayed. We need to have formal protocols for personal protective equipment and for social distancing and ensure that everyone follows the protocols rigorously. We should attempt not to use diathermy during these procedures because diathermy can generate aerosols which are potentially infective. We should only allow people into the operating room who are truly required and not allow ancillary personnel to be in the operating room to potentially thwart our social distancing or other preventative measures.

We also have a responsibility to those industry representatives who may be working with us. They should observe social distancing and all personnel safety protocols. They should only be in the operating room for that period of time where their services are required. As much of the programming and training that can be done remotely should be done this way to keep protecting patients and these industry workers from the risk of infection.

I want to finish off by speaking to the effect of COVID-19 on the INS and how we hope to help our members during this pandemic. Many conferences have been postponed, made virtual or cancelled. I recently lectured virtually at the Spanish Neuromodulation Society Meeting and will do so soon for the Brazilian Neuromodulation Society. The INS is using a similar virtual approach to some of our meetings. We are currently determining with Philippe Rigoard and the European chapter presidents the fate of the Second European INS Chapters meeting in Paris. Originally scheduled to be held at the Palais de Congres in Paris this past June, the meeting was postponed and we hope soon to have a final date for this meeting whether it be virtual or in person. Professor Rigoard and his team have developed a fascinating and state of the art program.

The upcoming Third INS Interim Meeting in Mumbai has been postponed from October 2020 to November 19-21, 2021 and Professor Doshi continues to develop an exciting program for this face to face meeting. We are still cautiously optimistic that our 15th World Congress in Barcelona in May of 2021 will go on without a hitch but we are continuously re-evaluating data as the program is finalized.

In the interim, the INS has encouraged virtual regional meetings and requested online content to be available to all INS members, to provide ongoing neuromodulation education during this critical time. Second, the INS has developed a series of monthly webinars, the first eight of which will review and update the NACC (Neuromodulation Appropriateness Consensus Committee) guidelines. The next four webinars will discuss and update the PACC (Polyanalgesic Consensus Conference) guidelines concerning intraspinal drug delivery. I personally encourage all of you to go to the INS website where these are advertised and you can sign up to attend online. The INS provides continuing education credits for its members who attend the webinars, and offers video recordings of the webinars on the members’ website.

Second, the INS has initiated a quarterly Virtual Journal Club webinar each of which will involve the presentation and discussion of one major article in the neuromodulation literature. Please again check with the INS website for registration details. The first of these was held on August 4th of this year. We presented and discussed an article authored by Adnan Al-Kaisy and colleagues evaluating anatomic versus physiologic placement of spinal cord stimulation electrodes.

Last of all we have been working on further upgrading both the quality and volume of our journal, Neuromodulation: Technology at the Neural Interface. I am thrilled to announce that we have just received our new Impact Factor which has risen to a remarkable 4.03. Last year our impact factor was approximately 2.7 and a jump of this magnitude is almost unheard of. This is not simply a result of improving numbers for many medical journals. Last year our journal was ranked in the 50th percentile of journals in the general field of neurology; this year we are at the 20th percentile! We have risen to the upper echelon of journals in this area which I think reflects the kind of energy and care that I, Dr. Robert Forman and all of those involved in the authorship and review process of the journal have put into making this the best journal in this field. Neuromodulation is now getting a significantly increased degree of attention worldwide. I encourage all of you to submit your work, and particularly anything relevant to COVID, to the journal.

Again, I honor those of you who have been working in this COVID environment and I wish health and safety for you and your families. Despite the COVID-19 pandemic, with your help and the efforts of the INS, I believe that increasing populations of patients will gain access to neuromodulation therapies which continue to increase in both their safety and efficacy.

Robert M. Levy, MD, PhD
INS President

New Journal Impact Factor

We are pleased to announce the Impact Factor for Neuromodulation: Technology at the Neural Interface has increased to 4.029, bringing it to rank 45/204 in the Clinical Neurology JCR Category.

The editors', editorial board members', reviewers' and authors' contributions have been essential to reaching this milestone for the journal. We thank you for sharing in its success and invite you to submit your work to Neuromodulation!

INS 15th World Congress

Plans are progressing for the International Neuromodulation Society World Congress in Barcelona May 1 - 6, 2021. The congress chair is Carlos Tornero, MD, PhD, and co-chair is David Abejon, MD, PhD.

Proposals have been reviewed, and submitters will be notified of the outcome in the coming weeks.

Scientific program chairs Elliot Krames, MD, and Fabián Piedimonte, MD, PhD, are implementing a world-class program.

With the theme “Neuromodulation: From Scientific Theory to Revolutionary Therapy”, this biennial conference sets forth how neuromodulation therapies – from deep brain stimulation for movement disorders, epilepsy and psychiatric disorders, to spinal cord stimulation for chronic pain and locomotion, to sacral nerve stimulation for urinary and fecal incontinence – have developed from rigorous scientific theory and matured into proven clinical therapies. The strong underpinning in scientific theory has provided a foundation for rigorous study of mechanisms of action, which led to refinement and personalization of neuromodulation techniques. The 15th INS World Congress will include plenary sessions from world experts, oral presentations, panel discussions, oral abstract presentations and poster sessions that cover the basic science, mechanisms of action and clinical effectiveness of neuromodulation therapies. The event will provide networking opportunities to convey knowledge from multiple disciplines about current practice, future developments, and solutions for neuromodulation therapy of the central, peripheral, and autonomic nervous system.

We look forward to seeing you to Barcelona in 2021, as we continue to further knowledge about this fascinating field in the 30th year of INS biennial international scientific conferences.

INS 15th World Congress Call for Abstracts

The International Neuromodulation Society (INS) Congress committees invite you to submit your abstract to the INS’s 15th World Congress, "Neuromodulation: From Scientific Theory to Revolutionary Therapy”. The abstract system is now open, and the submission deadline is Nov. 3, 2020.

This opportunity to present your original, leading edge research to your fellow colleagues and experts from around the world comes only once every two years, so we invite you to seize this opportunity to share your research with international colleagues in Barcelona from May 1 to 6, 2021.

The top five abstracts will be recognized for their quality, originality and ingenuity in basic or clinical science.

The overall program will present the full breadth neuromodulation-related topics that encompass basic science, mechanisms of action, neural engineering, socioeconomics and global trends, emerging technologies, and translational and clinical research, including interventions for the brain, spine, and peripheral nerves.

Director-at-Large-Election Results

The INS congratulates the two new Directors-at-Large who were elected by our members, Magdalena Anitescu, MD, PhD, and Steven Falowski, MD. They will begin their three-year terms in September 2020.

Each of the candidates would have made an excellent Director-at-Large, and thank Drs. David Abejon, Juan Carlos Andreani, Jefferey Arle, G. Baranidharan, Kenneth Chapman, Magdy Hassouna and Shalini Shah for stepping forward to run in this election. We anticipate that all the candidates will continue to make impactful contributions to our global society and the field overall.

2nd Joint Congress of the INS European Chapters

By Prof. Philippe Rigoard, MD, PhD
INS 2nd Joint European Congress Chair

Update as of 08.07.2020

The health and well-being of our participants and their families is our main concern. Following the latest developments regarding the ongoing COVID-19 pandemic and actions taken by governments around the world, we are currently in discussions about the next steps in case we will be forced to postpone the e-INS 2020 congress.

We will announce our final decision in the coming weeks, in the meantime, we kindly ask for your patience and support, and wish you, your colleagues and families good health and resilience.

International Neuromodulation Society Centers of Excellence Surveys

Like any maturing field, neuromodulation has evolved significantly since deep brain stimulation was first performed in the early 1950s and spinal cord stimulation was first performed in the late 1960s. Today hundreds of thousands of patients worldwide are benefiting from implanted neurostimulators, and still more from non-invasive neuromodulation, thanks to rapidly evolving technical advances and increasingly sophisticated knowledge of the brain and nervous system function. Of note, however, are the wide variations in neuromodulator training, and procedure efficacy, outcomes, complications, and cost.

INS President Dr. Robert Levy first proposed that the INS initiate creation of Neuromodulation Centers of Excellence in Neuromodulation: Technology at the Neural Interface in 2014 (Neuromodulation. 2014;17: 1-9.). The concept has been successfully implemented in other specialties, such as cardiology/cardiac surgery, vascular surgery, colorectal surgery, bariatric surgery and epilepsy.

After assuming the INS presidency, Dr. Levy created a Centers of Excellence (COE) Committee to explore how the concept might be applied to develop a certification program for neuromodulation. Committee members are currently investigating other center-of-excellence models and discussing the characteristics that would distinguish a Neuromodulation Center of Excellence.

INS members recently had an opportunity to participate in a survey on peripheral nerve stimulation – a first of several surveys launched by INS through the COE Committee. The committee received more than 200 responses and we wanted to take this opportunity to thank those who shared their thoughts and wisdom through survey participation.

The information collected from this and future surveys on deep brain stimulation, gastroelectrical stimulation, and sacral neuromodulation will help committee members to understand the current state of affairs in each facet of neuromodulation.  It will then be used –  in conjunction with members’ perception of requisites to become the “center of excellence” – to come up with certain generally acceptable requirements and qualifications to establish and promote the entire COE concept.

Projects like this would not be possible without active participation of INS members. In addition to the survey response, the members will be invited to contribute to future discussion on this topic. The initial data collection is an important cornerstone for all subsequent debates and decision-making.

As the fastest-growing, worldwide multidisciplinary body devoted to building knowledge of neuromodulation, the INS is uniquely positioned to work with neuromodulation experts to improve patient access, safety and outcomes. Neuromodulation Centers of Excellence hold promise to establish a solid foundation for shaping the future practice and success of neuromodulation.

2020 PACC Survey Reveals Evolution of Intrathecal Drug Delivery

Twenty years ago the Polyanalgesic Consensus Committee (PACC) distributed a survey designed to access the practice of intrathecal drug delivery (IDD). That ground-breaking survey revealed remarkable variation in IDD practices and laid the foundation for the first PACC publication, which offered guidance on medication choices and presented efficacy and safety data. Results of a second PACC survey, conducted in 2009, were used to shape subsequent PACC guideline recommendations. The 2020 PACC survey was sent to all active International Neuromodulation Society (INS) members and sought information regarding demographics, application of the 2017 PACC guidelines, and current clinical practice. The results of the recent survey are being prepared for publication in Neuromodulation: Technology at the Neural Interface.

Comparison of the three PACC surveys demonstrates the evolution of IDD, which has been incorporated  into treatment algorithms that include underlying pain mechanisms, tiered medication choices, and guidance about patient selection and therapy trialing. The most recent survey results will inform the 2021 PACC guidelines and identify gaps in current recommendations and studies, all with the goal of improving IDD efficacy and safety.

The PACC surveys and guidelines illustrate the ongoing commitment of INS and neuromodulation specialists worldwide to refining therapies that alleviate pain.

New Monthly INS Webinars

The International Neuromodulation Society has a new free webinar series for members featuring renowned experts reviewing The Neurostimulation Appropriateness Consensus Committee (NACC) and The Polyanalgesic Consensus Conference (PACC) guidelines.

The webinars offer INS members a maximum of 1.5 AMA PRA Category 1 Credit(s)^TM and videos of the recorded sessions may be accessed upon logging in to the Members Only area of the INS website.

Future INS webinar dates and topics are:

Wednesday, Aug. 19, 2020 
NACC Webinar 4: Salvage for Failed Spinal Cord Stimulation Therapy - Case Presentations and Discussions

Thursday, Sept. 10, 2020
NACC Webinar 5: Spinal Cord Stimulation - Regional Differences in Access and Policy

Thursday, Oct. 8, 2020
NACC Webinar 6: Questions and Answers
 
Tuesday, Nov. 3, 2020
PACC Webinar 1: Status of Intrathecal Pharmacotherapy for Pain 2020

Tuesday, Dec. 1, 2020
PACC Webinar 2: Intrathecal Drug Delivery - Complications and Management

Thursday, Jan. 7, 2021
PACC Webinar 3: Algorithmic Approach to Intrathecal Drug Delivery ITDD for Different Pain Syndromes

Tuesday, Feb. 9, 2021
PACC Webinar 4: Questions and Answers

Virtual Journal Club Starts

The International Neuromodulation Society has begun a new, quarterly Virtual Journal Club with its International Women in Neuromodulation and Young Neuromodulators committees.

The inaugural session took place on Aug. 4, 2020, with 177 people registered. We thank everyone who participated, and who made the event possible. The event was moderated by INS President Robert Levy, MD, PhD, and organized by panelists Alexios G. Carayannopoulos, DO, MPH; Sean Li, MD; and Moein Tavakkoli, MD, FRCA, chairs of the Young Neuromodulators Committee.

Heather Pinckard-Dover, MD, presented the article that was discussed, Comparison of Paresthesia Mapping to Anatomical Placement in Burst Spinal Cord Stimulation: Initial Trial Results of the Prospective, Multicenter, Randomized, Double‐Blinded, Crossover, CRISP Study, which was published in Neuromodulation: Technology at the Neural Interface  March 2020 by Adnan Al‐Kaisy MD, Ganesan Baranidharan MD, Stefano Palmisani MD, David Pang MD, Onita Will BSc Hons, Samuel Wesley BSc Hons, Tracey Crowther RN, Karl Ward RN, Paul Castino, Adil Raza MPH, Filippo Agnesi PhD:

Al‐Kaisy, A., Baranidharan, G., Palmisani, S., Pang, D., Will, O., Wesley, S., Crowther, T., Ward, K., Castino, P., Raza, A. and Agnesi, F. (2020), Comparison of Paresthesia Mapping to Anatomical Placement in Burst Spinal Cord Stimulation: Initial Trial Results of the Prospective, Multicenter, Randomized, Double‐Blinded, Crossover, CRISP Study. Neuromodulation: Technology at the Neural Interface, 23: 613-619. doi:10.1111/ner.13104

Among the participants discussing the article were the lead author, Dr. Al-Kaisy; and Richard North, MD, a 2019 recipient of the INS Giant of Neuromodulation award who has served on the Neuromodulation editorial board since its inception, and has authored seminal papers regarding spinal cord stimulation therapy for chronic pain.

INS Virtual Journal Club sessions offer CME credit for INS members who participate in the live event.

Session recordings are made available on the INS members' website for later viewing.

Many articles will come from the official INS journal, Neuromodulation: Technology at the Neural Interface.

The goal of the journal club is to offer an objective, non-commercial platform for discussing timely studies of neuromodulation techniques and clinical practice.

Please stay tuned for upcoming sessions, and let us know if you are interested in getting involved.

Select INS 14th World Congress Presentations in Members Only Section

INS members may access PDFs of slides, and/or audio recordings of talks, from presenters who have consented to have those materials made available following their presentations at the INS 14th World Congress in 2019 in Sydney, Australia. Please enjoy this educational member benefit by making use of the world-class knowledge and viewpoints presented during the INS 14th World Congress.

These materials, and similar materials from previous INS world congresses, are available after logging into the INS Members Only Section of the INS website.

To access them, please log in with your member credentials. You may request a username reminder or password reset by following the links at the bottom of the log in interface:

After logging in, navigate to the link for Congress Proceedings (this area will only be accessible after logging in).

New INS Website Feature: Keep Me Logged In Function

To enhance members' use of the INS website, INS members now have an option, when logging in to the INS website, to select the check-box for “keep me logged in”.

On most browsers, this allows access to resources in the Members Only area of the INS website for up to two weeks, as long as the user does not manually log out. (If you have difficulty, clearing your cache in your browser may help.)

Remaining logged in allows convenient members-only access to:

Membership benefit links

• The journal Neuromodulation
• Select INS World Congress proceedings
• INS Monthly Webinars
• INS Quarterly Virtual Journal Club
• INS Mentorship Program
• Fact sheets for members
• Image Bank for members
• Members-Only discussion forums

Membership tools

• View and edit your member profile (with a public directory option, tips)
• Renew your membership
• INS member search

Member resources

• Web resources for member chapters
• Media toolkit
• Twitter advice for members
• Wiley publication discounts
• Neurotech Reports product database

The INS Members Only resources also include a reminder about finding the INS official journal, Neuromodulation: Technology at the Neural Interface, on Twitter, Facebook, and Instagram.

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