Abstract:The TNM™ device for CVS appears to provide a clinically efficacious and highly tolerable adjuvant therapy for the prevention of episodic migraine.
“…It can be expected that those devices exclusively tested in open-label studies will be studied for the efficacy in randomized, sham-controlled trials. Beyond that novel devices with entirely different mechanisms of action may become available (59,60). Finally, the expansion of clinical trials on other primary headaches such as the indomethacin-responsive headaches is expected as preliminary results of some of the devices revealed promising results and these headache syndromes frequently lead to a significant reduction of quality of life as treatment options are limited and commonly associated with side-effects that require their discontinuation.…”
Word count abstract: 200 wordsWord count main text: 5006 words References: 60
Abstract
IntroductionNeuromodulation techniques play an increasing role in the treatment of primary headaches. While initially reserved for refractory cases they are now increasingly taken into consideration in earlier treatment phases and in non-refractory situations. One of the main reasons of this paradigm shift is that most neuromodulation techniques are better tolerated as compared to the majority of pharmacological approaches. However, these techniques have their limitations that should be considered.
Areas coveredThe review provides an overview of the available techniques and their therapeutic rationale as well as on the evidence for their efficacy and their limitations. The review covers these aspects for non-invasive vagal nerve stimulation, sphenopalatine ganglion stimulation, external trigeminal nerve stimulation, occipital nerve stimulation as well as single-pulse and repetitive-pulse transcranial magnetic stimulation.
Expert commentaryMost of the evidence is based on open-label studies. Sham devices used in controlled studies remain problematic as they either do not produce the paresthesias perceived during stimulation or induce some degree of stimulation. Invasive techniques require a surgical intervention with all the potential complications that may arise.In summary some of the techniques provide an effective expansion of available treatment options but their indication should be thoroughly evaluated before treatment is considered.
Conflict of InterestJan Hoffmann is consulting for/served on advisory boards for Allergan,
“…It can be expected that those devices exclusively tested in open-label studies will be studied for the efficacy in randomized, sham-controlled trials. Beyond that novel devices with entirely different mechanisms of action may become available (59,60). Finally, the expansion of clinical trials on other primary headaches such as the indomethacin-responsive headaches is expected as preliminary results of some of the devices revealed promising results and these headache syndromes frequently lead to a significant reduction of quality of life as treatment options are limited and commonly associated with side-effects that require their discontinuation.…”
Word count abstract: 200 wordsWord count main text: 5006 words References: 60
Abstract
IntroductionNeuromodulation techniques play an increasing role in the treatment of primary headaches. While initially reserved for refractory cases they are now increasingly taken into consideration in earlier treatment phases and in non-refractory situations. One of the main reasons of this paradigm shift is that most neuromodulation techniques are better tolerated as compared to the majority of pharmacological approaches. However, these techniques have their limitations that should be considered.
Areas coveredThe review provides an overview of the available techniques and their therapeutic rationale as well as on the evidence for their efficacy and their limitations. The review covers these aspects for non-invasive vagal nerve stimulation, sphenopalatine ganglion stimulation, external trigeminal nerve stimulation, occipital nerve stimulation as well as single-pulse and repetitive-pulse transcranial magnetic stimulation.
Expert commentaryMost of the evidence is based on open-label studies. Sham devices used in controlled studies remain problematic as they either do not produce the paresthesias perceived during stimulation or induce some degree of stimulation. Invasive techniques require a surgical intervention with all the potential complications that may arise.In summary some of the techniques provide an effective expansion of available treatment options but their indication should be thoroughly evaluated before treatment is considered.
Conflict of InterestJan Hoffmann is consulting for/served on advisory boards for Allergan,
“…The vestibular neuroscience of migraine is explored in Black et al, 2018 (invited review, Headache Currents). Time-varying CVS demonstrated efficacy in reducing headache burden in episodic migraineurs (Wilkinson et al, 2017). Migraineurs used the CVS device on a daily basis, at home.…”
Section: Vnmmentioning
confidence: 99%
“…This is an interesting example as it points out the spectral nature of diseases like schizophrenia where improvement in one symptom may still have an impact on patient outcomes. Wilkinson et al (2017) offered clear evidence of benefit from time-varying CVS for idiopathic episodic migraine. Why this is so is unknown, but we noted earlier that the brain actually does try to re-establish normal sensory habituation during an attack.…”
We describe a model of neurological disease based on dysfunctional brain oscillators. This is not a new model, but it is not one that is generally appreciated by clinicians. The value of this model lies in the predictions it makes and the utility it provides in translational applications, in particular for neuromodulation devices. We provide a perspective on the difference between neuromodulation devices that enforce an externally administered stimulus with devices that provide input to sensory receptors and thus stimulate endogenous sensory networks. Current forms of clinically applied neuromodulation are of the former type, including devices such as (implanted) deep brain stimulators (DBS) and various, noninvasive methods such as transcranial magnetic stimulation (TMS) and transcranial current methods (tACS, tDCS). The challenge with these methods is that they are not sensitive to underlying neuronal dynamics and work by applying an empirically derived electrical current waveform to affect dynamical patterns. Neuromodulation of a sensory organ accesses the same pathways that natural environmental stimuli do and, importantly, the modulatory signal will be transformed as it travels through the brain, allowing the modulation input to be consistent with regional dynamics. We present specific examples of devices that rely on sensory neuromodulation and evaluate the translational potential of these approaches. We argue that sensory neuromodulation is well suited to probe and, ideally, repair dysfunctional brain oscillators, thus providing a novel therapeutic approach for neurological diseases.
“…The vestibular neuroscience of migraine is explored in Balaban et al (2019). Time-varying CVS (tvCVS) demonstrated efficacy in reducing headache burden in episodic migraineurs (Wilkinson et al, 2017). Migraineurs used the CVS device on a daily basis, at home.…”
We describe a model of neurological disease based on dysfunctional brain oscillators. This is not a new model, but it is not one that is widely appreciated by clinicians. The value of this model lies in the predictions it makes and the utility it provides in translational applications, in particular for neuromodulation devices. Specifically, we provide a perspective on devices that provide input to sensory receptors and thus stimulate endogenous sensory networks. Current forms of clinically applied neuromodulation, including devices such as (implanted) deep brain stimulators (DBS) and various, noninvasive methods such as transcranial magnetic stimulation (TMS) and transcranial current methods (tACS, tDCS), have been studied extensively. The potential strength of neuromodulation of a sensory organ is access to the same pathways that natural environmental stimuli use and, importantly, the modulatory signal will be transformed as it travels through the brain, allowing the modulation input to be consistent with regional neuronal dynamics. We present specific examples of devices that rely on sensory neuromodulation and evaluate the translational potential of these approaches. We argue that sensory neuromodulation is well suited to, ideally, repair dysfunctional brain oscillators, thus providing a broad therapeutic approach for neurological diseases.
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