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Safety Information


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Neurostimulation (Neuromodulation) Systems: General Information

The incidence of patients receiving implanted neurostimulation systems for treatment of neurological disorders and other conditions is increasing. Because of the inherent design and intended function of neurostimulation systems, the electromagnetic fields used for MR procedures may produce a variety of problems with these devices. For example, altered function of a neurostimulation system that results from exposure to the electromagnetic fields of an MR system may cause discomfort, pain, or injury to the patient.

MRI-related heating has been reported to cause the greatest concern for many different devices used for neurostimulation. Importantly, the exact criteria for the particular neurostimulation system with regard to the implantable pulse generator (PG), leads, electrodes, and operational aspects of the device and the MR system conditions must be defined by comprehensive testing and carefully followed to ensure patient safety.

Please refer to the Safety Information section of www.MRIsafety.com for the type of neurostimulation system (also called, "neuromodulation system") that may be present in the patient referred for an MRI examination for specific guidelines.

[MRI healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MRI procedure.]

REFERENCES
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Baker KB, Tkach JA, Nyenhuis JA, Phillips M, Shellock FG, Gonzalez-Martinez J, Rezai AR. Evaluation of specific absorption rate as a dosimeter of MRI-Related implant heating. Journal of Magnetic Resonance Imaging 2004;20:315-320.

Baker KB, Tkach J, Hall JD, Nyenhuis JA, Shellock FG, Rezai AR. Reduction of MRI-related heating in deep brain stimulation leads using a lead management system. Neurosurgery 2005;57:392-397.

Baker KB, Tkach JA, Phillips MD, Rezai AR. Variability in RF-induced heating of a deep brain stimulation implant across MR systems. J Magn Reson Imaging 2006;24:1236-42.

Bhidayasiri R, Bronstein JM, Sinha S, Krahl SE, Ahn S, Behnke EJ, Cohen MS, Frysinger R, Shellock FG. Bilateral neurostimulation systems used for deep brain stimulation: In vitro study of MRI-related heating at 1.5-Tesla and implications for clinical imaging of the brain. Magnetic Resonance Imaging 2005;23:549-555.

Chhabra V, Sung E, et al. Safety of magnetic resonance imaging of deep brain stimulator systems: a serial imaging and clinical retrospective study. J Neurosurg. 2009 Aug 14. [Epub ahead of print]

De Andres J, Valia JC, et al. Magnetic resonance imaging in patients with spinal neurostimulation systems. Anesthesiology. 2007;106:779-86.

Dormont D, Cornu P, Pidoux B, Bonnet AM, Biondi A, Oppenheim C, Hasboun D, Damier P, et al. Chronic thalamic stimulation with three-dimensional MR stereotactic guidance. AJNR Am J Neuroradiol 1997;18:1093-1097.

Elkelini MS, Hassouna MM. Safety of MRI at 1.5-Tesla in patients with implanted sacral nerve neurostimulator. Eur Urol. 2006 Aug;50(2):311-6.

Finelli DA, Rezai AR, Ruggieri P, Tkach J, Nyenhuis J, Hridlicka G, Sharan A, Stypulkowski PH, Shellock FG. MR-related heating of deep brain stimulation electrodes: an in vitro study of clinical imaging sequences. AJNR Am J Neuroradiol 2002;23:1795-1802.

Georgi A-C, Stippich C, Tronnier VM, Heiland S. Active deep brain stimulation during MRI: a feasibility study. Magn Reson in Medicine 2003;51:380-388.

Gleason CA, Kaula NF, Hricak H, et al. The effect of magnetic resonance imagers on implanted neurostimulators. Pacing Clin Electrophysiol 1992;15:81-94.

Henderson J, Tkach J, Phillips M, Baker K, Shellock FG, Rezai A. Permanent neurological deficit related to magnetic resonance imaging in a patient with implanted deep brain stimulation electrodes for Parkinson’s disease: Case report. Neurosurgery 2005;57:E1063.

Kovacs N, Nagy F, Kover F, et al. Implanted deep brain stimulator and 1.0-Tesla magnetic resonance imaging. J Magn Reson Imaging. 2006;24:1409-12.

Larson PS, Richardson RM, Starr PA, Martin AJ. Magnetic resonance imaging of implanted deep brain stimulators: experience in a large series. Stereotact Funct Neurosurg. 2008;86:92-100.

Liem LA, van Dongen VC. Magnetic resonance imaging and spinal cord stimulation systems. Pain 1997;70:95-97.

Mogilner AY, Rezai AR. Brain stimulation: history, current clinical application, and future prospects. Acta Neurochir Suppl. 2003;87:115-120.

Mohsin SA, Sheikh NM, Saeed U. MRI-induced heating of deep brain stimulation leads. Phys Med Biol. 2008;53:5745-56.

Phillips MD, Baker KB, Lowe MJ, et al. Parkinson disease: pattern of functional MR imaging activation during deep brain stimulation of subthalamic nucleus--initial experience. Radiology. 2006;239:209-16.

Rezai AR, et al. Thalamic stimulation and functional magnetic resonance imaging: localization of cortical and subcortical activation with implanted electrodes. J Neurosurg 1999;90;583-590.

Rezai AR, Baker K, Tkach J, Phillips M, Hrdlicka G, Sharan A, Nyenhuis J, Ruggieri P, Henderson J, Shellock FG. Is magnetic resonance imaging safe for patients with neurostimulation systems used for deep brain stimulation (DBS)? Neurosurgery 2005;57:1056-1062.

Rezai AR, Finelli D, Ruggieri P, Tkach J, Nyenhuis JA, Shellock FG. Neurostimulators: Potential for excessive heating of deep brain stimulation electrodes during MR imaging. Journal of Magnetic Resonance Imaging 2001;14:488-489.

Rezai AR, Finelli D, Nyenhuis JA, Hrdlick G, Tkach J, Ruggieri P, Stypulkowski PH, Sharan A, Shellock FG. Neurostimulator for deep brain stimulation: Ex vivo evaluation of MRI-related heating at 1.5-Tesla. Journal of Magnetic Resonance Imaging 2002;15:241-250.

Rezai AR, Phillips M, Baker K, Sharan AD, Nyenhuis J, Tkach J, Henderson J, Shellock FG. Neurostimulation system used for deep brain stimulation (DBS): MR safety issues and implications of failing to follow guidelines. Investigative Radiology 2004;39:300-303.

Rise MT. Instrumentation for neuromodulation. Archives Of Medical Research 2000;31:237-247

Shellock FG. MRI Safety and Neuromodulation Systems.In: NEUROMODULATION Krames ES, Peckham PH, Rezai, AR, Editors. Academic Press/Elsevier, New York, 2009.

Shellock FG. Magnetic Resonance Procedures: Health Effects and Safety. CRC Press, LLC, Boca Raton, FL, 2001.

Shellock FG. MR imaging and electronically-activated devices. Radiology. 219:294-295, 2001.

Shellock FG. MR safety update 2002: Implants and devices. Journal of Magnetic Resonance Imaging 2002;16:485-496.

Shellock FG. Begnaud J, Inman DM. VNS Therapy System: In vitro evaluation of MRI-related heating and function at 1.5- and 3-Tesla. Neuromodulation 2006;9:204-213.

Shellock FG, Cosendai G, Park S-M, Nyenhuis JA. Implantable microstimulator: magnetic resonance safety at 1.5-Tesla. Investigative Radiology 2004;39:591-594.

Smith CD, Kildishev AV, Nyenhuis JA, Foster KS, Bourland JD, Interactions of MRI magnetic fields with elongated medical implants. J Appl Physics 2000; 87:6188-6190.

Smith CD, Nyenhuis JA, Kildishev AV. Chapter 16. Health effects of induced electrical currents: Implications for implants. In: Magnetic resonance: health effects and safety, FG Shellock, Editor, CRC Press, Boca Raton, FL, 2001; pp. 393-413.

Spiegel J, et al. Transient dystonia following magnetic resonance imaging in a patient with deep brain stimulation electrodes for the treatment of Parkinson disease. J Neurosurgery 2003;99:772-774.

Tagliati M, Jankovic J, et al. and the National Parkinson Foundation DBS Working Group. Safety of MRI in patients with implanted deep brain stimulation devices. Neuroimage. 2009;47 Suppl 2:T53-7.

Tronnier VM, Stauber A, Hahnel S, Sarem-Aslani A. Magnetic resonance imaging with implanted neurostimulation systems: an in vitro and in vivo study. Neurosurgery 1999;44:118-25.

Utti RJ, Tsuboi Y, et al, Wharen RE. Magnetic resonance imaging and deep brain stimulation. Neurosurgery 2002;51:1423-1431.

Zonenshayn M, Mogilner AY, Rezai AR. Neurostimulation and functional brain stimulation. Neurological Research 2000;22;318-325.

 
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