The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Bleeding and Coagulation Management in Neurostimulation Devices.

INTRODUCTION: The Neurostimulation Appropriateness Consensus Committee (NACC) was formed by the International Neuromodulation Society (INS) in 2012 to evaluate the evidence to reduce the risk of complications and improve the efficacy of neurostimulation. The first series of papers, published in 2014, focused on the general principles of appropriate practice in the surgical implantation of neurostimulation devices. The NACC was reconvened in 2014 to address specific patient care issues, including bleeding and coagulation. METHODS: The INS strives to improve patient care in an evidence-based fashion. The NACC members were appointed or recruited by the INS leadership for diverse expertise, including international clinical expertise in many areas of neurostimulation, evidence evaluation, and publication. The group developed best practices based on peer-reviewed evidence and, in the absence of specific evidence, on expert opinion. Recommendations were based on international evidence in accordance with guideline creation. CONCLUSIONS: The NACC has recommended specific measures to reduce the risk of bleeding and neurological injury secondary to impairment of coagulation in the setting of implantable neurostimulation devices in the spine, brain, and periphery.

The Neurostimulation Appropriateness Consensus Committee (NACC) Recommendations for Infection Prevention and Management.

INTRODUCTION: The use of neurostimulation for pain has been an established therapy for many decades and is a major tool in the arsenal to treat neuropathic pain syndromes. Level I evidence has recently been presented to substantiate the therapy, but this is balanced against the risk of complications of an interventional technique. METHODS: The Neurostimulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society convened an international panel of well published and diverse physicians to examine the best practices for infection mitigation and management in patients undergoing neurostimulation. The NACC recommendations are based on evidence scoring and peer-reviewed literature. Where evidence is lacking the panel added expert opinion to establish recommendations. RESULTS: The NACC has made recommendations to improve care by reducing infection and managing this complication when it occurs. These evidence-based recommendations should be considered best practices in the clinical implantation of neurostimulation devices. CONCLUSION: Adhering to established standards can improve patient care and reduce the morbidity and mortality of infectious complications in patients receiving neurostimulation.

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury.

INTRODUCTION: Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation. METHODS: The International Neuromodulation Society (INS) is dedicated to improving neurostimulation efficacy and patient safety. Over the past two decades the INS has established a process to use best evidence to improve care. This article updates work published by the NACC in 2014. NACC authors were chosen based on nomination to the INS executive board and were selected based on publications, academic acumen, international impact, and diversity. In areas in which evidence was lacking, the NACC used expert opinion to reach consensus. RESULTS: The INS has developed recommendations that when properly utilized should improve patient safety and reduce the risk of injury and associated complications with implantable devices. CONCLUSIONS: On behalf of INS, the NACC has published recommendations intended to reduce the risk of neurological injuries and complications while implanting stimulators.

Trigemino-Cervical Neuropathic Pain Relieved by Serially Repeated Peripheral Nerve Field Stimulation Without Tolerance: Case Report.

BACKGROUND: With its relative simplicity and safety, peripheral nerve field stimulation (PNFS; PENS) is contributing to the re-emergence of peripheral nerve stimulation as an effective therapy for neuropathic pain (NPP). CASE PRESENTATION: A 70-year-old woman had developed severe, medically refractory NPP unilaterally in the scalp and face 20 years earlier, following a maxillofacial surgical procedure. PNFS gave substantial relief of the pain and allodynia and was repeated successfully on a further 25 occasions over the subsequent five years. Tolerance did not develop. CONCLUSION: Serially repeated PNFS can provide sustained relief of NPP over long periods, without tolerance, where a permanent implant may be inappropriate, unavailable, or declined.

Modeling Two-Channel Speech Processing With the EPIC Cognitive Architecture.

An important application of cognitive architectures is to provide human performance models that capture psychological mechanisms in a form that can be "programmed" to predict task performance of human-machine system designs. Although many aspects of human performance have been successfully modeled in this approach, accounting for multitalker speech task performance is a novel problem. This article presents a model for performance in a two-talker task that incorporates concepts from psychoacoustics, in particular, masking effects and stream formation.

Enhancing listener strategies using a payoff matrix in speech-on-speech masking experiments.

Speech recognition was measured as a function of the target-to-masker ratio (TMR) with syntactically similar speech maskers. In the first experiment, listeners were instructed to report keywords from the target sentence. Data averaged across listeners showed a plateau in performance below 0 dB TMR when masker and target sentences were from the same talker. In this experiment, some listeners tended to report the target words at all TMRs in accordance with the instructions, while others reported keywords from the louder of the sentences, contrary to the instructions. In the second experiment, stimuli were the same as in the first experiment, but listeners were also instructed to avoid reporting the masker keywords, and a payoff matrix penalizing masker keywords and rewarding target keywords was used. In this experiment, listeners reduced the number of reported masker keywords, and increased the number of reported target keywords overall, and the average data showed a local minimum at 0 dB TMR with same-talker maskers. The best overall performance with a same-talker masker was obtained with a level difference of 9 dB, where listeners achieved near perfect performance when the target was louder, and at least 80% correct performance when the target was the quieter of the two sentences.

The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee.

INTRODUCTION: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications. METHODS: The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar. RESULTS: Neurostimulation is relatively safe because of its minimally invasive and reversible characteristics. Comparison with medical management is difficult, as patients considered for neurostimulation have failed conservative management. Unlike alternative therapies, neurostimulation is not associated with medication-related side effects and has enduring effect. Device-related complications are not uncommon; however, the incidence is becoming less frequent as technology progresses and surgical skills improve. Randomized controlled studies support the efficacy of spinal cord stimulation in treating failed back surgery syndrome and complex regional pain syndrome. Similar studies of neurostimulation for peripheral neuropathic pain, postamputation pain, postherpetic neuralgia, and other causes of nerve injury are needed. International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated. CONCLUSIONS: Appropriate neurostimulation is safe and effective in some chronic pain conditions. Technological refinements and clinical evidence will continue to expand its use. The NACC seeks to facilitate the efficacy and safety of neurostimulation.

Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads.

INTRODUCTION: While reference is frequently made to the risk of spinal cord or nerve root injury with the surgical implantation of paddle type spinal cord stimulation (SCS) electrodes, data are lacking on the frequency, causes, and prevention of these complications. METHODS: To determine the incidence and frequency of neurologic complications, we performed 1) a comprehensive analysis of the literature to determine the incidence of complications that have caused or could lead to neurologic injury; 2) an analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) data base; and 3) an investigation of manufacturers' data on surgically implanted paddle electrodes. We then convened an expert panel of neurosurgeons experienced in the surgical implantation of paddle electrodes to provide recommendations to minimize the risk of neurologic injury. RESULTS: The scientific literature describes the breadth of neurologic complications that can result from SCS electrode implantation but does not provide interpretable data with respect to the incidence and frequency of these complications. The MAUDE data base is not constructed to be sensitive or specific enough to provide these critical data. Primary data show a risk of neurologic injury from implantation of paddle electrodes below 0.6%. DISCUSSION: Preoperative, intraoperative, and postoperative measures to further minimize this risk are described. CONCLUSIONS: This investigation, the first comprehensive evaluation of the incidence and frequency of neurologic injury as a result of SCS paddle electrode implantation, suggests that neurologic injury is a rare, but serious, complication of SCS. The incidence of these complications should be decreased by the adoption of approaches that improve procedural safety and by careful patient follow-up and complication management. Physicians should be aware of these approaches and take every precaution to reduce the risk of neurologic injury. Physicians also should report any adverse event leading to injury or death and work together to improve access to these data.

Effects of target-masker contextual similarity on the multimasker penalty in a three-talker diotic listening task.

In many multitalker listening tasks, the degradation in performance that occurs when the number of interfering talkers increases from one to two is much larger than would be predicted from the corresponding decrease in the signal-to-noise ratio (SNR). In this experiment, a variety of contextually-relevant speech maskers, contextually-irrelevant speech maskers and non-speech maskers were used to examine the impact that the characteristics of the interfering sound sources have on the magnitude of this "multimasker penalty." The results show that a significant multimasker penalty only occurred in cases where two specific conditions were met: 1) the stimulus contained at least one contextually-relevant masker that could be confused with the target; and 2) the signal-to-noise ratio of the target relative to the combined masker stimulus was less than 0 dB. Remarkably, in cases where one masker was contextually relevant, the specific characteristics of the second masker had virtually no impact on the size of the multimasker penalty. Indeed, when the results were corrected for random guessing, there was essentially no difference in performance between conditions with three contextually-relevant talkers and those with two contextually-relevant talkers and one irrelevant talker. The results of a second experiment suggest that the listeners are generally able to hear keywords spoken by all three talkers even in situations where the multimasker penalty occurs, implying that the primary cause of the penalty is a degradation in the listener's ability to use prosodic cues and voice characteristics to link together words spoken at different points in the target phrase.

Cancer pain: part 2: physical, interventional and complimentary therapies; management in the community; acute, treatment-related and complex cancer pain: a perspective from the British Pain Society endorsed by the UK Association of Palliative Medicine and the Royal College of General Practitioners.

OBJECTIVE: This discussion document about the management of cancer pain is written from the pain specialists' perspective in order to provoke thought and interest in a multimodal approach to the management of cancer pain, not just towards the end of life, but pain at diagnosis, as a consequence of cancer therapies, and in cancer survivors. It relates the science of pain to the clinical setting and explains the role of psychological, physical, interventional and complementary therapies in cancer pain. METHODS: This document has been produced by a consensus group of relevant healthcare professionals in the United Kingdom and patients' representatives making reference to the current body of evidence relating to cancer pain. In the second of two parts, physical, invasive and complementary cancer pain therapies; treatment in the community; acute, treatment-related and complex cancer pain are considered. CONCLUSIONS: It is recognized that the World Health Organization (WHO) analgesic ladder, whilst providing relief of cancer pain towards the end of life for many sufferers world-wide, may have limitations in the context of longer survival and increasing disease complexity. To complement this, it is suggested that a more comprehensive model of managing cancer pain is needed that is mechanism-based and multimodal, using combination therapies including interventions where appropriate, tailored to the needs of an individual, with the aim to optimize pain relief with minimization of adverse effects.

Effects of bandwidth on auditory localization with a noise masker.

Although high-frequency content is known to be critically important for the accurate location of isolated sounds, relatively little is known about the importance of high-frequency spectral content for the localization of sounds in the presence of a masker. In this experiment, listeners were asked to identify the location of a pulsed-noise target in the presence of a randomly located continuous noise masker. Both the target and masker were low-pass filtered at one of eight cutoff frequencies ranging from 1 to 16 kHz, and the signal-to-noise ratio was varied from -12 to +12 dB. The results confirm the importance of high frequencies for the localization of isolated sounds, and show that high-frequency content remains critical in cases where the target sound is masked by a spatially separated masker. In fact, when two sources of the same level are randomly located in space, these results show that a decrease in stimulus bandwidth from 16 to 12 kHz might result in a 30% increase in overall localization error.

Multitalker speech perception with ideal time-frequency segregation: effects of voice characteristics and number of talkers.

When a target voice is masked by an increasingly similar masker voice, increases in energetic masking are likely to occur due to increased spectro-temporal overlap in the competing speech waveforms. However, the impact of this increase may be obscured by informational masking effects related to the increased confusability of the target and masking utterances. In this study, the effects of target-masker similarity and the number of competing talkers on the energetic component of speech-on-speech masking were measured with an ideal time-frequency segregation (ITFS) technique that retained all the target-dominated time-frequency regions of a multitalker mixture but eliminated all the time-frequency regions dominated by the maskers. The results show that target-masker similarity has a small but systematic impact on energetic masking, with roughly a 1 dB release from masking for same-sex maskers versus same-talker maskers and roughly an additional 1 dB release from masking for different-sex masking voices. The results of a second experiment measuring ITFS performance with up to 18 interfering talkers indicate that energetic masking increased systematically with the number of competing talkers. These results suggest that energetic masking differences related to target-masker similarity have a much smaller impact on multitalker listening performance than energetic masking effects related to the number of competing talkers in the stimulus and non-energetic masking effects related to the confusability of the target and masking voices.

Effects of periodic masker interruption on the intelligibility of interrupted speech.

When listeners hear a target signal in the presence of competing sounds, they are quite good at extracting information at instances when the local signal-to-noise ratio of the target is most favorable. Previous research suggests that listeners can easily understand a periodically interrupted target when it is interleaved with noise. It is not clear if this ability extends to the case where an interrupted target is alternated with a speech masker rather than noise. This study examined speech intelligibility in the presence of noise or speech maskers, which were either continuous or interrupted at one of six rates between 4 and 128 Hz. Results indicated that with noise maskers, listeners performed significantly better with interrupted, rather than continuous maskers. With speech maskers, however, performance was better in continuous, rather than interrupted masker conditions. Presumably the listeners used continuity as a cue to distinguish the continuous masker from the interrupted target. Intelligibility in the interrupted masker condition was improved by introducing a pitch difference between the target and speech masker. These results highlight the role that target-masker differences in continuity and pitch play in the segregation of competing speech signals.

Efficacy of spinal cord stimulation for neuropathic pain: assessment by abstinence.

Assessment of the efficacy of spinal cord stimulation (SCS) against neuropathic pain remains problematic. Some patients may underestimate this, as revealed by their reaction to stimulator malfunction. This study investigated whether abstinence from SCS would provide an indication of its effectiveness. Patients were invited to complete two brief questionnaires each day for 50 days including two periods of 14 days without stimulation. Pain level, sleep quality, activity level and drug intake were recorded. Of 75 patients thought to be using their stimulators, 12 did not respond to the invitation, eight had unresolved technical problems and one no longer needed SCS. Of the 54 remaining, 10 did not wish to be without SCS and 15 declined without giving a reason. Thus 29 agreed to take part but three then dropped out through illness and questionnaires were not received from 10. Ten returned completed questionnaires but failed to follow the protocol; five of these were unable to leave their stimulators off. Only six took part correctly. Twenty of the 29 had received a preliminary explanatory home visit and for nine this was done by telephone. The former produced a considerably higher yield. All six who completed the study correctly had statistically significantly lower pain scores during stimulation. Four had improved sleep but only one reduced his medication and none of the six increased their activity levels. Correlation with previous clinical assessments is discussed. It is concluded that the abstinence principle might provide a useful tool but its power is very methodology-dependent.