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Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Results from a randomized, multicenter, double-blinded, controlled study
Silberstein, Stephen D; Dodick, David W; Saper, Joel; Huh, Billy; Slavin, Konstantin V; Sharan, Ashwini; Reed, Ken; Narouze, Samer; Mogilner, Alon; Goldstein, Jerome; Trentman, Terrence; Vaisma, Julien; Ordia, Joseph; Weber, Peter; Deer, Timothy; Levy, Robert; Diaz, Roni L; Washburn, Stephanie N; Mekhail, Nagy
Background: Chronic migraine (CM) is a debilitating neurological disorder with few treatment options. Peripheral nerve stimulation (PNS) of the occipital nerves is a potentially promising therapy for CM patients. Methods: In this randomized, controlled multicenter study, patients diagnosed with CM were implanted with a neurostimulation device near the occipital nerves and randomized 2:1 to active (n = 105) or sham (n = 52) stimulation. The primary endpoint was a difference in the percentage of responders (defined as patients that achieved a >/=50% reduction in mean daily visual analog scale scores) in each group at 12 weeks. Results: There was not a significant difference in the percentage of responders in the Active compared with the Control group (95% lower confidence bound (LCB) of -0.06; p = 0.55). However, there was a significant difference in the percentage of patients that achieved a 30% reduction (p = 0.01). Importantly, compared with sham-treated patients, there were also significant differences in reduction of number of headache days (Active Group = 6.1, baseline = 22.4; Control Group = 3.0, baseline = 20.1; p = 0.008), migraine-related disability (p = 0.001) and direct reports of pain relief (p = 0.001). The most common adverse event was persistent implant site pain. Conclusion: Although this study failed to meet its primary endpoint, this is the first large-scale study of PNS of the occipital nerves in CM patients that showed significant reductions in pain, headache days, and migraine-related disability. Additional controlled studies using endpoints that have recently been identified and accepted as clinically meaningful are warranted in this highly disabled patient population with a large unmet medical need. Trial registration: Clinical trials.gov (NCT00615342).
PMID: 23034698
ISSN: 0333-1024
CID: 198362
Occipital Nerve Stimulation for Refractory Headache in the Chiari Malformation Population
Vadivelu, S; Bolognese, P; Milhorat, TH; Mogilner, AY
BACKGROUND: Chronic occipital and suboccipital headache is a common symptom in patients with Chiari I malformation (CMI). These headaches may persist despite appropriate surgical treatment of the underlying pathology via suboccipital decompression, duraplasty and cerebrospinal fluid diversion. Occipital nerve stimulation (ONS) has been shown to be effective in the treatment of a variety of occipital headache/pain syndromes. OBJECTIVE: We retrospectively reviewed our experience with ONS in patients with a primary diagnosis of Chiari malformation (CM) and a history of chronic occipital pain intractable to medical and surgical therapies. METHODS: We present a retrospective analysis of our series of 22 patients with CM and persistent occipital headaches who underwent occipital neurostimulator trials and, following successful trials, permanent stimulator placement. A trial was considered successful with greater than 50% pain relief using a standard visual analog score (VAS). Patients with a successful trial underwent permanent placement approximately one to two weeks later. Patients were assessed postoperatively for pain relief via VAS. RESULTS: Sixty-eight percent (15/22) of patients had a successful stimulator trial and proceeded to permanent implant. Of those implanted, 13/15 (87%) reported continued pain relief at a mean follow-up of 18.9 months (6 - 51 months). Device-related complications requiring additional surgeries occurred in 40% of patients. CONCLUSION: Occipital stimulation may provide significant long-term pain relief in selected CMI patients with persistent occipital pain. Larger and longer-term studies are needed to further define appropriate patient selection criteria as well as to refine the surgical technique to minimize device-related complications.
PMID: 22418582
ISSN: 0148-396x
CID: 162583
Using imaging to identify psychogenic parkinsonism before deep brain stimulation surgery. Report of 2 cases [Case Report]
Pourfar, Michael H; Tang, Chris C; Mogilner, Alon Y; Dhawan, Vijay; Eidelberg, David
The frequency with which patients with atypical parkinsonism and advanced motor symptoms undergo deep brain stimulation (DBS) procedures is unknown. However, the potential exposure of these patients to unnecessary surgical risks makes their identification critical. As many as 15% of patients enrolled in recent early Parkinson disease (PD) trials have been found to lack evidence of a dopaminergic deficit following PET or SPECT imaging. This suggests that a number of patients with parkinsonism who are referred for DBS may not have idiopathic PD. The authors report on 2 patients with probable psychogenic parkinsonism who presented for DBS surgery. They found that both patients had normal caudate and putamen [(18)F]-fluorodopa uptake on PET imaging, along with normal expression of specific disease-related metabolic networks for PD and multiple system atrophy, a common form of atypical neurodegenerative parkinsonism. The clinical and PET findings in these patients highlight the role of functional imaging in assisting clinical decision making when the diagnosis is uncertain.
PMID: 22077446
ISSN: 0022-3085
CID: 162584
The use of intraoperative electrophysiology for the placement of spinal cord stimulator paddle leads under general anesthesia
Mammis, A; Mogilner, AY
BACKGROUND:: Placement of spinal cord stimulating paddle leads has traditionally been performed using local anesthesia with intravenous sedation to allow for intraoperative confirmation of appropriate placement. It may be difficult to maintain appropriate sedation in certain patients due to medical comorbidities. Furthermore, patients undergoing lead revision frequently have extensive epidural scarring, requiring multi-level laminectomies to place the electrode appropriately. OBJECTIVE:: We report our technique of neurophysiologic monitoring which allows these procedures to be performed under general anesthesia. METHODS:: Data from 78 patients who underwent electromyography (EMG) during laminectomy for paddle lead placement were retrospectively reviewed. 70 patients presented for first-time permanent system placement following a successful trial, and 8 were referred for revision or replacement of previously functioning systems. Surgeries were performed under general anesthesia, with fluoroscopic guidance. EMG was used to help define the physiologic midline of the spinal cord and guide appropriate lead placement. Somatosensory evoked potentials (SSEP) were used as an adjunct to minimize the possibility of neural injury. RESULTS:: Immediately postoperatively, 75 of 78 patients reported that the paresthesia coverage was as good (or better) as that of the SCS trial. At long-term follow-up, 1 system was removed for infection, and 6 systems were explanted for lack of efficacy. A total of 64 of the 78 implanted patients reported continued pain relief with stimulator use. Revision surgery was performed in 9 patients. CONCLUSION:: The use of intraoperative electrophysiology for the placement of SCS paddle leads under general anesthesia is a safe and efficacious alternative to awake surgery.
PMID: 21869720
ISSN: 0148-396x
CID: 162585
Peripheral neurostimulation for the treatment of refractory cluster headache, long-term follow-up: case report [Case Report]
Mammis, Antonios; Gudesblatt, Mark; Mogilner, Alon Y
INTRODUCTION: Cluster headache is a headache syndrome characterized by periodic episodes of intense headache with spontaneous remission. There are recent reports utilizing occipital nerve stimulation for the successful management of medically refractory cases of cluster headache. METHODS: The case of an 18-year-old boy with chronic, refractory, recurrent cluster headaches is presented. He was treated surgically with combined occipital, supraorbital, and infraorbital nerve stimulation. RESULTS: Prior to operation, the patient suffered three to four episodes of cluster headache per day, for four years. After implantation of occipital, supraorbital, and infraorbital nerve stimulators, the patient averages at most three to four headaches per month, at 36-month follow-up. CONCLUSION: Peripheral neurostimulation is safe and efficacious in the management of chronic, medically refractory cluster headache syndrome. The efficacy of treatment was found to be persistent after three years.
PMID: 21854497
ISSN: 1094-7159
CID: 162586
Occipital neuromodulation for refractory headache in the Chiari malformation population
Vadivelu, Sudhakar; Bolognese, Paolo; Milhorat, Thomas H; Mogilner, Alon Y
Chronic occipital and suboccipital headache is a common symptom in patients with Chiari I malformation (CMI). These headaches may persist despite appropriate surgical treatment of the underlying pathology via suboccipital decompression, duraplasty and related procedures. Occipital stimulation has been shown to be effective in the treatment of a variety of occipital headache/pain syndromes. We present our series of 18 patients with CMI and persistent occipital headaches who underwent occipital neurostimulator trials and, following successful trials, permanent stimulator placement. Seventy-two percent (13/18) of patients had a successful stimulator trial and proceeded to permanent implant. Of those implanted, 11/13 (85%) reported continued pain relief at a mean follow-up of 23 months. Device-related complications requiring additional surgeries occurred in 31% of patients. Occipital neuromodulation may provide significant long-term pain relief in selected CMI patients with persistent occipital pain. Larger and longer-term studies are needed to further define appropriate patient selection criteria as well as to refine the surgical technique to minimize device-related complications.
PMID: 21422782
ISSN: 0079-6492
CID: 162587
A technique of distal to proximal revision of peripheral neurostimulator leads: technical note [Case Report]
Mammis, Antonios; Mogilner, Alon Y
BACKGROUND: Peripheral nerve stimulation for chronic pain states is a safe and efficacious technique, being used with increasing frequency. The incidence of hardware-related complications requiring revision remains high. OBJECTIVES: The authors describe a technique of distal to proximal neurostimulator lead revision, which does not require the changing of generators or extension leads, and thus presumably will minimize further device-related complications. METHODS: The authors present a case series of 3 patients where the distal to proximal neurostimulator lead revision technique was utilized. RESULTS: The technique was well tolerated in each instance and all patients reported >50% pain reduction at long-term follow-up. CONCLUSIONS: The distal to proximal neurostimulator lead revision technique quickly and safely adjusts lead position, including both lead depth and lead tip location, without a need for replacement of components or revision of the entire system.
PMID: 21293164
ISSN: 1011-6125
CID: 162588
Intrathecal bupivacaine for head and neck pain
Belverud, Shawn A; Mogilner, Alon Y; Schulder, Michael
Direct central nervous system (CNS) analgesic delivery is a useful option when more traditional means of dealing with chronic pain fail. Solutions containing local anesthetic have been effective in certain disease states, particularly in patients suffering from intractable head and neck pain. This review discusses historical aspects of CNS drug delivery and the role of intrathecal bupivacaine-containing solutions in refractory head and neck pain patients.
PMCID:3417958
PMID: 22915879
ISSN: 1178-7112
CID: 930542
Bitemporal electroconvulsive therapy for depression in a Parkinson disease patient with a deep-brain stimulator [Case Report]
Bailine, Samuel; Kremen, Neil; Kohen, Izchak; Linder, Howard; Schwartz, Guy J; Mogilner, Alon Y; Pourfar, Michael
We report the successful treatment of an episode of major depression with psychotic features with electroconvulsive therapy (ECT) in a 78-year-old woman with advanced Parkinson disease who had a left subthalamic nucleus deep-brain stimulator (DBS) in place. Electroconvulsive therapy effectively and safely treated the patient's depression without harming the patient or damaging the DBS hardware. We offer additional evidence about the safety and efficacy of electroconvulsive therapy in patients with DBS.
PMID: 18580566
ISSN: 1095-0680
CID: 162589
Intrathecal pumps
Belverud, Shawn; Mogilner, Alon; Schulder, Michael
Direct neuroaxis drug delivery has expanded the physician's armamentarium to provide treatment options to those who have failed more conservative interventions. Starting from Bier's 'cocainization of the spinal cord' in 1898, direct nervous system pharmacy delivery has long been recognized as an effective means to treat pain. Intrathecal pump systems are now commonplace in the management of numerous pain states, as well as of neuromuscular sequelae of central nervous system injury. There has been much advancement in the physiologic and pharmacologic understanding of direct neuromodulation, providing a growing number of treatment options depending on the specific disease state. As well, surgical techniques and catheter systems have undergone refinements providing improved long-term safety and efficacy. We present a review of the historical evolution to current intrathecal therapies, as well as a dialog regarding patient selection, drug options, and side effects. Also, included is a discussion of surgical techniques, current delivery options and complications concerning pump placement.
PMCID:5084133
PMID: 18164490
ISSN: 1878-7479
CID: 162590