36 results match your criteria treatment gammacore


The Cost of Lost Productivity in an Opioid Utilizing Pain Sample.

J Pain Res 2021 4;14:2347-2357. Epub 2021 Aug 4.

The Spine and Nerve Center of the Virginias, Charleston, WV, USA.

Background And Aims: Chronic pain affects more adults in the United States than any other condition. Opioid medications are widely used in the treatment of chronic pain, but there remains considerable risk and cost associated with their use. This study aims to characterize the effects of opioid prescribing for chronic pain and similar pain conditions on lost productivity in the United States. Read More

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gammaCore for Cluster Headaches: A NICE Medical Technologies Guidance.

Pharmacoecon Open 2021 Jul 28. Epub 2021 Jul 28.

Cedar, Cardiff and Vale University Health Board, Cardiff, UK.

Cluster headaches are excruciating attacks of pain that can last between 15 min and 3 h. Cluster headaches can be episodic, where patients have long pain-free intervals between attacks, or chronic, where they do not. As part of the Medical Technologies Evaluation Programme, the UK National Institute for Health and Care Excellence (NICE) considered the clinical effectiveness and cost impact of gammaCore (electroCore), a handheld, patient-controlled device used to treat and prevent cluster headache. Read More

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Vagal nerve stimulation as a possible non-invasive treatment for chronic widespread pain in Gulf Veterans with Gulf War Illness.

Life Sci 2021 Oct 5;282:119805. Epub 2021 Jul 5.

Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston TX, USA.

Aims: Widespread pain and headache are common in Gulf War Illness with suboptimal treatments available. We tested the efficacy of non-invasive, transcutaneous vagal nerve stimulation (nVNS) for relief of widespread pain and migraine in Gulf War Veterans with GWI.

Main Methods: A 10-week double-blind, randomized controlled trial of nVNS used the gammaCore (ElectroCore, Inc. Read More

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October 2021

Peripheral Neuromodulation for the Management of Headache.

Anesth Pain Med 2020 Dec 30;10(6):e110515. Epub 2020 Nov 30.

Department of Anesthesiology, LSU Health Shreveport, Shreveport, LA, USA.

Context: Neuromodulation is an expanding field of study for headache treatment to reduce pain by targeting structures within the nervous system that are commonly involved in headache pathophysiology, such as the vagus nerve (VNS), occipital nerves, or sphenopalatine ganglion (SPG) for stimulation. Pharmaceutical medical therapies for abortive and prophylactic treatment, such as triptans, NSAIDs, beta-blockers, TCAs, and antiepileptics, are effective for some individuals, but the role that technology plays in investigating other therapeutic modalities is essential. Peripheral neuromodulation has gained popularity and FDA approval for use in treating certain headaches and migraine headache conditions, particularly in those who are refractory to treatment. Read More

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December 2020

Two-Week Cervical Vagus Nerve Stimulation in Chronic Pancreatitis Patients Induces Functional Connectivity Changes of Limbic Structures.

Neuromodulation 2021 Jun 14. Epub 2021 Jun 14.

Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.

Objectives: Noninvasive vagus nerve stimulation (nVNS) has not only shown antinociceptive effects, but also demonstrated anti-inflammatory and antidepressant effects. These effects could be beneficial in chronic pancreatitis (CP) patients suffering from chronic abdominal pain, even though the underlying central mechanisms remain unclear. The aim was to investigate the effect of cervical nVNS in patients with painful CP on brain functional connectivity and cerebral metabolites. Read More

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Cervical transcutaneous vagal neuromodulation in chronic pancreatitis patients with chronic pain: A randomised sham controlled clinical trial.

PLoS One 2021 26;16(2):e0247653. Epub 2021 Feb 26.

Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.

Background & Aims: Chronic abdominal pain is the primary symptom of chronic pancreatitis, but unfortunately it is difficult to treat. Vagal nerve stimulation studies have provided evidence of anti-nociceptive effect in several chronic pain conditions. We investigated the pain-relieving effects of transcutaneous vagal nerve stimulation in comparison to sham treatment in chronic pancreatitis patients. Read More

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Drugs for Migraine.

Authors:

Med Lett Drugs Ther 2020 10;62(1608):153-160

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October 2020

Non-invasive Autonomic Neuromodulation Is Opening New Landscapes for Cardiovascular Diseases.

Front Physiol 2020 15;11:550578. Epub 2020 Dec 15.

Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, China.

Autonomic imbalance plays a crucial role in the genesis and maintenance of cardiac disorders. Approaches to maintain sympatho-vagal balance in heart diseases have gained great interest in recent years. Emerging therapies However, certain types of emerging therapies including direct electrical stimulation and nerve denervation require invasive implantation of a generator and a bipolar electrode subcutaneously or result in autonomic nervous system (ANS) damage, inevitably increasing the risk of complications. Read More

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December 2020

Feasibility of Non-Invasive Vagus Nerve Stimulation (gammaCore VET™) for the Treatment of Refractory Seizure Activity in Dogs.

Front Vet Sci 2020 16;7:569739. Epub 2020 Sep 16.

Friendship Hospital for Animals, Washington, DC, United States.

Idiopathic epilepsy is the most common chronic neurologic condition in dogs. Approximately 20-30% of those dogs are refractory to standard medical therapy and commonly experience side effects from antiepileptic drugs. Non-invasive vagus nerve stimulation (nVNS) has been frequently used in human medicine as an adjunct seizure therapy with low incidence of adverse events. Read More

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September 2020

Noninvasive vagal nerve stimulation for gastroenterology pain disorders.

Pain Manag 2021 Jan 28;11(1):89-96. Epub 2020 Oct 28.

Division of Gastroenterology & Hepatology, Department of Medicine, Stanford University, Stanford, CA 94305, USA.

Abdominal pain continues to be a major challenge and unmet need in clinical practice. Normalization of bidirectional gut-brain signaling has generated much interest as a therapeutic approach to treat chronic abdominal pain. Vagal nerve stimulation (VNS) is emerging as a potential non-pharmacologic strategy for the treatment of abdominal pain. Read More

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January 2021

Update on noninvasive neuromodulation for migraine treatment-Vagus nerve stimulation.

Prog Brain Res 2020 6;255:249-274. Epub 2020 Jul 6.

Headache Unit, IRCCS Neuromed, Pozzilli (IS), Italy.

Noninvasive neurostimulation methods are particularly suited for migraine treatment thanks to their most favorable adverse event profile. Among them, noninvasive vagus nerve stimulation (nVNS) has raised great hope because of the role the vagus nerve is known to play in pain modulation, inflammation and brain excitability. We will critically review the clinical studies performed for migraine attack treatment and migraine prevention with the GammaCore® device, which allows cervical vagus nerve stimulation. Read More

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Effect of Headache-Free Days on Disability, Productivity, Quality of Life, and Costs Among Individuals with Migraine.

J Manag Care Spec Pharm 2020 Oct 17;26(10):1344-1352. Epub 2020 Jul 17.

Teva Branded Pharmaceutical Products R&D, West Chester, Pennsylvania.

Background: The functional impairment associated with migraine can cause physical, emotional, and economic ramifications that can affect occupational, academic, social, and family life. Understanding the relationship between headache-free days (HFDs) and the disease burden of migraine may help with decisions regarding treatment and management of migraine.

Objective: To determine the relationship between burden of disease measures and HFDs among individuals with migraine experiencing ≥ 4 headache days in the previous 30 days. Read More

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October 2020

A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial".

Trials 2020 Jun 26;21(1):576. Epub 2020 Jun 26.

Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.

Objectives: Primary Objective: The primary objective is to reduce initiation of mechanical ventilator dependency in patients with moderate to severe CoViD- 19. This will be measured as the difference between the control group and active group for subjects admitted to the hospital for CoViD-19. Secondary Objectives: • To evaluate cytokine trends / Prevent cytokine storms • To evaluate supplemental oxygen requirements • To decrease mortality of CoViD-19 patients • Delay onset of ventilation TRIAL DESIGN: The study is a single centre, 2-arm, prospective, randomized (ratio 1:1), controlled trial with parallel groups design to compare the reduction of respiratory distress in a CoViD-19 population, using the intervention of the gammaCore®-Sapphire device plus standard of care (active) vs. Read More

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Patient experience with non-invasive vagus nerve stimulator: gammaCore patient registry.

Am J Manag Care 2020 02;26(1 Suppl):S15-S19

profecyINTEL, LLC, Bridgewater, NJ. Email:

gammaCore is cleared by the FDA for acute and preventive treatment of cluster headache and the acute treatment of migraine in adults. Previously, only 2 treatments were approved for acute treatment of cluster headache while none were approved for preventive treatment. Following the initial FDA clearance, based on the ACT-1 and ACT-2 studies, a gammaCore Patient Registry (GPR) was designed to provide insights on the use of gammaCore and prescription patterns in the real-world setting and to characterize respective benefits and challenges during the acute treatment of episodic cluster headache. Read More

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February 2020

Open-label pilot study: Non-invasive vagal nerve stimulation improves symptoms and gastric emptying in patients with idiopathic gastroparesis.

Neurogastroenterol Motil 2020 04 5;32(4):e13769. Epub 2019 Dec 5.

Division of Gastroenterology & Hepatology, Department of Medicine, Stanford University, Stanford, CA, USA.

Background: Gastroparesis, a chronic motility disorder characterized by delayed gastric emptying, abdominal pain, nausea, and vomiting, remains largely unexplained. Medical therapy is limited, reflecting the complex physiology of gastric sensorimotor function. Vagus nerve stimulation is an attractive therapeutic modality for gastroparesis, but prior methods required invasive surgery. Read More

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Study protocol for a randomised double-blinded, sham-controlled, prospective, cross-over clinical trial of vagal neuromodulation for pain treatment in patients with chronic pancreatitis.

BMJ Open 2019 08 23;9(7):e029546. Epub 2019 Aug 23.

Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.

Introduction: The management of chronic pancreatitis (CP) is challenging and requires a personalised approach focused on the individual patient's main symptoms. Abdominal pain is the most prominent symptom in CP, where central pain mechanisms, including sensitisation and impaired pain modulation, often are involved. Recent clinical studies suggest that vagal nerve stimulation (VNS) induces analgesic effects through the modulation of central pain pathways. Read More

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Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial.

Cephalalgia 2019 Oct 15;39(12):1475-1487. Epub 2019 Sep 15.

Leiden University Medical Center, Leiden, The Netherlands.

Introduction: Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data.

Methods: This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6-8 hours apart). Read More

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October 2019

Cost-effectiveness of noninvasive vagus nerve stimulation for acute treatment of episodic migraine and role in treatment sequence strategies.

Am J Manag Care 2018 12;24(24 Suppl):S527-S533

electroCore, Inc, Basking Ridge, NJ. Email:

Migraine affects 15% of the population in the United States and is associated with comorbidities, with an estimated economic burden of $78 billion annually. GammaCore is used adjunctively with current standard of care and abortive medications and has shown to be superior in acute treatment of episodic migraine compared to sham. However, the economic impact has not been characterized for this indication. Read More

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December 2018

Noninvasive vagus nerve stimulation in a primary care setting: effects on quality of life and utilization measures in multimorbidity patients with or without primary headache.

Am J Manag Care 2018 12;24(24 Suppl):S517-S526

electroCore, Inc, Basking Ridge, NJ. Email:

A patient audit was conducted in the UK to evaluate the impact of gammaCore use in multimorbidity patients on quality of life and healthcare resources utilization measures. A total of 233 patients were enrolled and their data was examined over a 1-year period after their gammaCore prescription. Of these patients, 132 (56%) had primary headache disorders while 101 (44%) were patients without a headache disorder (nonheadache patients). Read More

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December 2018

Review of evidence on noninvasive vagus nerve stimulation for treatment of migraine: efficacy, safety, and implications.

Am J Manag Care 2018 12;24(24 Suppl):S507-S516

electroCore, Inc, Basking Ridge, NJ. Email:

GammaCore was cleared by the FDA for the acute treatment of episodic migraine and episodic cluster headache and has 5 Conformité Européenne marks. Data indicate that gammaCore treatment is both safe and effective as an acute treatment for migraine. Current reimbursement policies need to be updated based on the growing body of evidence to reflect the established status of gammaCore that is no longer experimental. Read More

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December 2018

Non-invasive vagus nerve stimulation for treatment of cluster headache: early UK clinical experience.

J Headache Pain 2018 Nov 23;19(1):114. Epub 2018 Nov 23.

University Hospitals of North Midlands, Newcastle Road, Stoke-on-Trent, ST4 6QG, UK.

Background: Evidence supports the use of non-invasive vagus nerve stimulation (nVNS; gammaCore®) as a promising therapeutic option for patients with cluster headache (CH). We conducted this audit of real-world data from patients with CH, the majority of whom were treatment refractory, to explore early UK clinical experience with nVNS used acutely, preventively, or both.

Methods: We retrospectively analysed data from 30 patients with CH (29 chronic, 1 episodic) who submitted individual funding requests for nVNS to the National Health Service. Read More

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November 2018

Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized, sham-controlled, double-blind PRESTO trial.

J Headache Pain 2018 Oct 19;19(1):98. Epub 2018 Oct 19.

Headache and Pain Unit, IRCCS San Raffaele Pisana, Rome, Italy.

Background: The PRESTO study of non-invasive vagus nerve stimulation (nVNS; gammaCore®) featured key primary and secondary end points recommended by the International Headache Society to provide Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 h post stimulation. Here, we examined additional data from PRESTO to provide further insights into the practical utility of nVNS by evaluating its ability to consistently deliver clinically meaningful improvements in pain intensity while reducing the need for rescue medication.

Methods: Patients recorded pain intensity for treated migraine attacks on a 4-point scale. Read More

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October 2018

The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue and Immune Responses in Patients With Primary Sjögren's Syndrome.

Neuromodulation 2019 Jul 17;22(5):580-585. Epub 2018 Oct 17.

Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.

Objectives: Primary Sjögren's syndrome (pSS) sufferers have rated chronic fatigue as the most important symptom needing improvement. Emerging data suggest that stimulation of the vagus nerve can modulate immunological responses. The gammaCore device (electroCore), developed to stimulate the cervical vagus nerve noninvasively, was used to assess the effects of vagus nerve activation on immune responses and clinical symptoms of pSS. Read More

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Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study.

Neurology 2018 07 15;91(4):e364-e373. Epub 2018 Jun 15.

From the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.

Objective: To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.

Methods: A total of 248 participants with episodic migraine with/without aura were randomized to receive nVNS or sham within 20 minutes from pain onset. Participants were to repeat treatment if pain had not improved in 15 minutes. Read More

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Peripheral vagal nerve stimulation modulates the nociceptive withdrawal reflex in healthy subjects: A randomized, cross-over, sham-controlled study.

Cephalalgia 2018 09 20;38(10):1658-1664. Epub 2017 Nov 20.

1 Headache Science Centre, C. Mondino National Neurological Institute, Pavia, Italy.

Introduction The mechanism of action of non-invasive vagal nerve stimulation in the treatment of migraine is elusive. We studied its effect in a human model of pain, the nociceptive withdrawal reflex. Methods We enrolled 10 healthy subjects who underwent active non-invasive vagal nerve stimulation and sham treatment in a randomized, cross-over, sham-controlled study. Read More

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September 2018

Cost-effectiveness of gammaCore (non-invasive vagus nerve stimulation) for acute treatment of episodic cluster headache.

Am J Manag Care 2017 Nov;23(16 Suppl):S300-S306

Cluster headache is a debilitating disease characterized by excruciatingly painful attacks that affects 0.15% to 0.4% of the US population. Read More

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November 2017

The emerging role of gammaCore® in the management of cluster headache: expert panel recommendations.

Am J Manag Care 2017 Nov;23(17 Suppl):S326-S333

A panel of 9 experts, including neurologists, other headache specialists, and medical and pharmacy directors, from 4 health plans (1 integrated delivery network and 3 plans with commercial, Medicare, and Medicaid lines of business), convened to discuss cluster headache (CH). Topics covered included the current treatment landscape, treatment challenges, economic impact of disease, and gaps in care for patients with CH. One major challenge in the management of CH is that it is underrecognized and frequently misdiagnosed, leading to delays in and suboptimal treatment for patients who suffer from this painful and disabling condition. Read More

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November 2017

Review of non-invasive vagus nerve stimulation (gammaCore): efficacy, safety, potential impact on comorbidities, and economic burden for episodic and chronic cluster headache.

Am J Manag Care 2017 Nov;23(17 Suppl):S317-S325

The FDA has cleared gammaCore (non-invasive vagus nerve stimulator [nVNS]) for the treatment of episodic cluster headache (eCH). With the exception of subcutaneous sumatriptan, all other treatments are used off label and have many limitations. The FDA approval process for devices differs from that of drugs. Read More

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November 2017

Mechanism of action of non-invasive cervical vagus nerve stimulation for the treatment of primary headaches.

Am J Manag Care 2017 Nov;23(17 Suppl):S312-S316

Stimulation of the cervical vagus nerve with implanted vagus nerve stimulation (iVNS) has been used clinically for more than 20 years to treat patients with epilepsy. More recently, a non-invasive cervical vagus nerve stimulation (nVNS), gammaCore, was developed, which has been purported to also stimulate the vagus nerve without the cost and morbidity associated with an iVNS system. gammaCore has been used to acutely treat various types of primary headaches, including migraine and cluster headaches (CH), and for the prevention of episodic, chronic, and menstrual migraines and CH. Read More

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November 2017

Proof of concept: short-term non-invasive cervical vagus nerve stimulation in patients with drug-refractory gastroparesis.

Frontline Gastroenterol 2017 Oct 24;8(4):325-330. Epub 2017 May 24.

Royal Free London NHS Foundation Trust, London, UK.

Background: Gastric electric stimulation (GES) is a treatment approach to refractory gastroparesis, possibly acting centrally via afferent vagus nerve stimulation (VNS). Non-invasive VNS (nVNS) is a potential alternative to GES that could eliminate the safety risks of or identify likely responders to implantable neurostimulators.

Objective: This open-label proof-of-concept study assessed the effects of nVNS in patients with severe drug-refractory gastroparesis. Read More

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October 2017