MRI Safety and Neuromodulation Systems

Neuromodulation

Volumn 1, Issue , 2009, Pages 243-281

  Shellock, Frank G ^a  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84857123519     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-374248-3.00021-5     Document Type: Chapter

References (85)

1. Advanced Neuromodulation Systems (2008) http://www.ans-medical.com/patient/safetyinformation.cfm (accessed May 2008).
2. A. Amjad, A.V. Kildishev, S.M. Park and J.A. Nyenhuis (2005) Power deposition inside of a phantom for testing MRI heating. IEEE Trans. Magnetics 41 4185-4187.
3. ASTM (American Society for Testing and Materials) International, Designation: F2503-05 (2005) Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. West Conshohocken, PA: ASTM International.
4. V. Anderson and K. Burchiel (1999) A prospective study of long-term intrathecal morphine in the management of chronic nonmalignant pain. Neurosurgery 44 289-301.
5. I. Arcos, R. Davis, K. Fey, D. Mishler, D. Sanderson, C. Tanacs, M.J. Vogel, R. Wolf, Y. Zilberman and J. Schulman (2002) Second-generation microstimulator. Artif. Organs 26 228-231.
6. K.B. Baker, B.H. Kopell, D. Malone, C. Horenstein, M. Lowe, M.D. Phillips and A.R. Rezai (2007) Deep brain stimulation for obsessive–compulsive disorder: using functional magnetic resonance imaging and electrophysiological techniques: technical case report. Neurosurgery 61(5 Suppl. 2), E367-8.
7. K.B. Baker, J. Tkach, J.D. Hall, J.A. Nyenhuis, F.G. Shellock and A.R. Rezai (2005) Reduction of MRI-related heating in deep brain stimulation leads using a lead management system. Neurosurgery 57 392-397.
8. K.B. Baker, J.A. Tkach, J.A. Nyenhuis, M. Phillips, F.G. Shellock, J. Gonzalez-Martinez and A.R. Rezai (2004) Evaluation of specific absorption rate as a dosimeter of MRI-related implant heating. Journal of Magnetic Resonance Imaging 20 315-320.
9. K.B. Baker, J.A. Tkach, M.D. Phillips and A.R. Rezai (2006) Variability in RF-induced heating of a deep brain stimulation implant across MR systems. J. Magn. Reson. Imaging 24 1236-1242.
10. S.R. Benbadis, J. Nyhenhuis, W.O. Tatum IV, F.R. Murtagh, M. Gieron and F.L. Vale (2001) MRI of the brain is safe in patients implanted with the vagus nerve stimulator. Seizure 10 512-515.
11. R. Bhidayasiri, J.M. Bronstein, S. Sinha, S.E. Krahl, S. Ahn, E.J. Behnke, et al. (2005) 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. Magn. Reson. Imaging 23 549-555.
12. J.D. Bourland, J.A. Nyenhuis and D.J. Schaefer (1999) Physiologic effects of intense MRI gradient fields. Neuroimaging Clin. North Am. 9 363-377.
13. T. Cameron, G.E. Loeb, R.A. Peck, J.H. Schulman, P. Strojnik and P.R. Troyk (1997) Micromodular implants to provide electrical stimulation of paralyzed muscles and limbs. IEEE Trans. Biomed. Eng. 44 781-790.
14. D.W. Carmichael, S. Pinto, P. Limousin-Dowsey, S. Thobois, P.J. Allen, L. Lemieux, et al. (2007) Functional MRI with active, fully implanted, deep brain stimulation systems: safety and experimental confounds. Neuroimage 37 508-517.
15. P.M. Colletti (2001) Magnetic resonance procedures and pregnancy. F.G. Shellock (Eds) Magnetic Resonance Procedures: Health Effects and Safety Boca Raton, FL: CRC Press 149-182.
16. J. De Andres, J.C. Valía, G. Cerda-Olmedo, C. Quiroz, V. Villanueva, V. Martinez-Sanjuan, et al. (2007) Magnetic resonance imaging in patients with spinal neurostimulation systems. Anesthesiology 106 779-786.
17. M.F. Dempsey, B. Condon and D.M. Hadley (2001) Investigation of the factors responsible for burns during MRI. J. Magn. Reson. Imaging 13 627-631.
18. M.S. Elkelini and M.M. Hassouna (2006) Safety of MRI at 1.5-Tesla in patients with implanted sacral nerve neurostimulator. Eur. Urol. 50 311-316.
19. D.A. Finelli, A.R. Rezai, P. Ruggieri, J. Tkach, J. Nyenhuis, G. Hridlicka, et al. (2002) MR-related heating of deep brain stimulation electrodes: an in vitro study of clinical imaging sequences. AJNR 23 1795-1802.
20. A-C. Georgi, C. Stippich, V.M. Tronnier and S. Heiland (2003) Active deep brain stimulation during MRI: a feasibility study. Magn Reson Med. 51 380-388.
21. C.A. Gleason, N.F. Kaula, H. Hricak, et al. (1992) The effect of magnetic resonance imagers on implanted neurostimulators. Pacing Clin. Electrophysiol. 15 81-94.
22. H. Graf, U.A. Lauer, A. Berger and F. Schick (2005) RF artifacts caused by metallic implants or instruments which get more prominent at 3-T: an in vitro study. Magn. Reson. Imaging 23 493-499.
23. D.A. Groves and V.J. Brown (2005) Vagal nerve stimulation: a review of its applications and potential mechanisms that mediate its clinical effects. Neurosci. Biobehav. Rev. 29 493-500.
24. W.J. Heetderks (1988) RF powering of millimeter- and submillimeter-sized neural prosthetic implants. IEEE Trans. Biomed. Eng. 35 323-327.
25. J. Henderson, J. Tkach, M. Phillips, K. Baker, F.G. Shellock and A. Rezai (2005) Permanent neurological deficit related to magnetic resonance imaging in a patient with implanted deep brain stimulation electrodes for Parkinson’s disease: Case report. Neurosurgery 57 E1063.
26. Joint Commission on Accreditation of Healthcare Organizations, USA (2008) Preventing accidents and injuries in the MRI suite. Sentinel Event Alert Feb. 14 1-3.
27. A. Kangarlu, F.G. Shellock and D. Chakeres (2003) 8.0-Tesla MR system: temperature changes associated with radiofrequency-induced heating of a head phantom. J. Magn. Reson. Imaging 17 220-226.
28. L.J. Kim, V.K. Sonntag, J.T. Hott, J.A. Nemeth, J.D. Klopfenstein and L. Tweardy (2003) Scalp burns from halo pins following magnetic resonance imaging. Case Report. J. Neurosurg. 99 186.
29. M. Kosel and T.E. Schlaepfer (2003) Beyond the treatment of epilepsy: new applications of vagus nerve stimulation in psychiatry. CNS Spectr. 8 515-521.
30. N. Kovacs, F. Nagy, F. Kover, et al. (2006) Implanted deep brain stimulator and 1.0-Tesla magnetic resonance imaging. J. Magn. Reson. Imaging 24 1409-1412.
31. P.S. Larson, R.M. Richardson, P.A. Starr and A.J. Martin (2008) Magnetic resonance imaging of implanted deep brain stimulators: experience in a large series. Stereotact. Funct. Neurosurg. 86 92-100.
32. L.A. Liem and V.C. van Dongen (1997) Magnetic resonance imaging and spinal cord stimulation systems. Pain 70 95-97.
33. G.E. Loeb, R.A. Peck, W.H. Moore and K. Hood (2001) BION system for distributed neural prosthetic interfaces. Med. Eng. Phys. 23 9-18.
34. G.E. Loeb, F.J. Richmond and L.L. Baker (2006) The BION devices: injectable interfaces with peripheral nerves and muscles. Neurosurg. Focus 20 E2.
35. G.E. Loeb, C.J. Zamin, J.H. Schulman and P.R. Troyk (1991) Injectable microstimulator for functional electrical stimulation. Med. Biol. Eng. Comput. 29 NS13-NS19.
36. M. Lomarev, S. Denslow, Z. Nahas, J.H. Chae, M.S. George and D.E. Bohning (2002) Vagus nerve stimulation (VNS) synchronized BOLD fMRI suggests that VNS in depressed adults has frequency/dose dependent effects. J. Psychiatr. Res. 36 219-227.
37. E. Mattei, M. Triventi, G. Calcagnini, F. Censi, W. Kainz, H.I. Bassen, et al. (2007) Temperature and SAR measurement errors in the evaluation of metallic linear structures heating during MRI using fluoroptic probes. Phys. Med. Biol. 52 1633-1646.
38. E. Mattei, M. Triventi, G. Calcagnini, F. Censi, W. Kainz, G. Mendoza, et al. (2008) Complexity of MRI induced heating on metallic leads: experimental measurements of 374 configurations. Biomed. Eng. Online 3(7), 11.
39. MAUDE (2008) www.fda.gov/cdrh/maude.html (accessed May 2008).
40. M. McJury and F.G. Shellock (2000) Auditory noise associated with MR procedures: a review. J. Magn. Reson. Imaging 12 37-45.
41. Medtronic Neurological Technical Services Department (2005), Tech Note. MRI. Guidelines for Neurological Products, Issue No. NTN 04-03 Rev 2, July 2005.
42. MRIsafety.com (2008) http://MRIsafety.com (accessed May 2008).
43. T. Nakamura, K. Fukuda, K. Hayakawa, I. Aoki, K. Matsumoto, T. Sekine, et al. (2001) Mechanism of burn injury during magnetic resonance imaging (MRI)-simple loops can induce heat injury. Front Med. Biol. Eng. 11 117-129.
44. J.T. Narayanan, R. Watts, N. Haddad, D.R. Labar, P.M. Li and C.G. Filippi (2002) Cerebral activation during vagus nerve stimulation: a functional MR study. Epilepsia 43 1509-1514.
45. W.R. Nitz, G. Brinker, D. Diehl and G. Frese (2005) Specific absorption rate as a poor indicator of magnetic resonance-related implant heating. Invest. Radiol. 40 773-776.
46. J.A. Nyenhuis, S.M. Park, R. Kamondetdacha, A. Amjad, F.G. Shellock and A. Rezai (2005) MRI and implanted medical devices: basic interactions with an emphasis on heating. IEEE Trans. Device Mater. Reliability 5 467-478.
47. J. Olsrud, J. Latt, S. Brockstedt, B. Romner and I.M. Bjorkman-Burtscher (2005) Magnetic resonance imaging artifacts caused by aneurysm clips and shunt valves: dependence on field strength (1.5 and 3T) and imaging parameters. J. Magn. Reson. Imaging 22 433-437.
48. M.D. Phillips, K.B. Baker, M.J. Lowe, et al. (2006) Parkinson disease: pattern of functional MR imaging activation during deep brain stimulation of subthalamic nucleus – initial experience. Radiology 239 209-216.
49. Physician’s Manual, VNS Therapy (2003) Pulse Model 102 Generator and VNS Therapy, Pulse Duo Model 102R Generator, and Physician’s Manual, VNS Therapy Lead, Model 302. Houston, TX: Cyberonics, Inc
50. A.R. Rezai, K. Baker, J. Tkach, M. Phillips, G. Hrdlicka, A. Sharan, et al. (2005) Is magnetic resonance imaging safe for patients with neurostimulation systems used for deep brain stimulation (DBS)? Neurosurgery 57 1056-1062.
51. A.R. Rezai, D. Finelli, J.A. Nyenhuis, G. Hrdlick, J. Tkach, P. Ruggieri, et al. (2002) Neurostimulator for deep brain stimulation: Ex vivo evaluation of MRI-related heating at 1.5-Tesla. J. Magn. Reson. Imaging 15 241-250.
52. A.R. Rezai, D. Finelli, P. Ruggieri, J. Tkach, J.A. Nyenhuis and F.G. Shellock (2001) Neurostimulators: potential for excessive heating of deep brain stimulation electrodes during MR imaging. J. Magn. Reson. Imaging 14 488-489.
53. A.R. Rezai, A.M. Lozano, A.P. Crawley, M.L. Joy, K.D. Davis, C.L. Kwan, et al. (1999) Thalamic stimulation and functional magnetic resonance imaging: localization of cortical and subcortical activation with implanted electrodes. J. Neurosurg. 90 583-590.
54. A.R. Rezai, M. Phillips, K. Baker, A.D. Sharan, J. Nyenhuis, J. Tkach, et al. (2004) Neurostimulation system used for deep brain stimulation (DBS): MR safety issues and implications of failing to follow guidelines. Invest. Radiol. 39 300-303.
55. M.T. Rise (2000) Instrumentation for neuromodulation. Arch. Med. Res. 31 237-247.
56. R. von Roemeling, R.M. Lanning and F.A. Eames (1991) MR imaging of patients with implanted drug infusion pumps. J. Magn. Reson. Imaging 1 77-81.
57. Schaefer, D.J., Barber, B.J., Gordon, C.J. (1985) Thermal effects of magnetic resonance imaging. In: Book of Abstracts, Society for Magnetic Resonance in Medicine. Berkeley, CA, 2: 925.
58. D.J. Schaefer, J.D. Bourland and J.A. Nyenhuis (2000) Review of patient safety in time-varying gradient fields. J. Magn. Reson. Imaging 12 20-29.
59. J.F. Schenck (2001) Health effects and safety of static magnetic fields. F.G. Shellock (Eds) Magnetic Resonance Procedures: Health Effects and Safety Boca Raton, FL: CRC Press 1-30.
60. A. Sharan, A.R. Rezai, J.A. Nyenhuis, G. Hrdlicka, J. Tkach, K. Baker, et al. (2003) MR safety in patients with implanted deep brain stimulation systems (DBS). Acta Neurochir. Suppl. 87 141-145.
61. F.G. Shellock (2000) Radiofrequency energy-induced heating during MR procedures: a review. J. Magn. Reson. Imaging 12 30-36.
62. F.G. Shellock (2002) Biomedical implants and devices: assessment of magnetic field interactions with a 3.0-Tesla MR system. J. Magn. Reson. Imaging 16 721-732.
63. F.G. Shellock (2002) MR safety update 2002: Implants and devices. J. Magn. Reson. Imaging 16 485-496.
64. F.G. Shellock (2007) Guest Editorial. Comments on MRI heating tests of critical implants. J. Magn. Reson. Imaging 26 1182-1185.
65. F.G. Shellock (2008) Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2008 Edition. Los Angeles, CA: Biomedical Research Publishing Group
66. F.G. Shellock and E. Kanal (1991) Policies, guidelines, and recommendations for MR imaging safety and patient management. SMRI Safety Committee. J. Magn. Reson. Imaging 1 97-101.
67. F.G. Shellock and D.J. Schaefer (2001) Radiofrequency energy-induced heating during magnetic resonance procedures: laboratory and clinical experiences. F.G. Shellock (Eds) Magnetic Resonance Procedures: Health Effects and Safety Boca Raton, FL: CRC Press 75-96.
68. F.G. Shellock, J. Begnaud and D.M. Inman (2006) VNS Therapy System: In vitro evaluation of MRI-related heating and function at 1.5- and 3-Tesla. Neuromodulation 9 204-213.
69. F.G. Shellock, G. Cosendai, S-M. Park and J.A. Nyenhuis (2004) Implantable microstimulator: magnetic resonance safety at 1.5-Tesla. Invest. Radiol. 39 591-594.
70. F.G. Shellock, R. Crivelli and R. Venugopalan (2008) Programmable infusion pump and catheter: evaluation using 3-Tesla MRI. Neuromodulation 11 163-170.
71. F.G. Shellock, D.S. Fieno, T.J. Thomson, T.M. Talavage and D.S. Berman (2006) Cardiac pacemaker: in vitro assessment of MR safety at 1.5-Tesla. Am. Heart J. 151 436-443.
72. F.G. Shellock, S. Valencerina and L. Fischer (2005) MRI-related heating of pacemaker at 1.5- and 3-Tesla: Evaluation with and without pulse generator attached to leads. Circulation 112(Suppl. II), 561.
73. D. Shrivastava, T. Hanson, R. Schlentz, W. Gallaghar, C. Snyder, L. Delabarre, S. Prakash, P. Iaizzo and J.T. Vaughan (2008) Radiofrequency heating at 9.4T: in vivo temperature measurement results in swine. Magn Reson. Med. 59 73-78.
74. C.D. Smith, J.A. Nyenhuis and A.V. Kildishev (2001) Chapter 16. Health effects of induced electrical currents: Implications for implants. F.G. Shellock (Eds) Magnetic Resonance: Health Effects and Safety Boca Raton, FL: CRC Press 393-413.
75. T. Smith, C. Swainey and P. Coyne (2005) Pain management, including intrathecal pumps. Curr. Pain Headache Rep. 9 243-248.
76. J. Spiegel, G. Fuss, M. Backens, W. Reith, T. Magnus, G. Becker, et al. (2003) Transient dystonia following magnetic resonance imaging in a patient with deep brain stimulation electrodes for the treatment of Parkinson disease. J. Neurosurg. 99 772-774.
77. P.A. Starr, C.W. Christine, P.V. Theodosopoulos, N. Lindsey, D. Byrd, A. Mosley, et al. (2002) Implantation of deep brain stimulators into the subthalamic nucleus: technical approach and magnetic resonance imaging-verified lead locations. J. Neurosurg. 97 370-387.
78. M. Triventi, E. Mattei, G. Calcagnini, F. Censi, P. Bartolini, W. Kainz, et al. (2007) Magnetic-resonance-induced heating of implantable leads. Ann. Ist Super Sanita 43 229-240.
79. V.M. Tronnier, A. Stauber, S. Hahnel and A. Sarem-Aslani (1999) Magnetic resonance imaging with implanted neurostimulation systems: an in vitro and in vivo study. Neurosurgery 44 118-125.
80. M. Turner (2003) Intrathecal drug delivery. Acta Neurochir 87(Suppl.), 29-35.
81. R.J. Utti, Y. Tsuboi, R.A. Pooley, J.D. Putzke, M.F. Turk, Z.K. Wszolek, et al. (2002) Magnetic resonance imaging and deep brain stimulation. Neurosurgery 51 1423-1431.
82. J.S. Walter, L. Riedy, W. King, J.S. Wheeler, K. Najafi, C.L. Anderson, et al. (1997) Short-term bladder-wall response to implantation of microstimulators. J. Spinal Cord Med. 20 319-323.
83. T.O. Woods (2007) Standards for medical devices in MRI: present and future. J. Magn. Reson. Imaging 26 1186-1189.
84. L.A. Zaremba (2001) FDA guidance for magnetic resonance system safety and patient exposures: current status and future considerations. F.G. Shellock (Eds) Magnetic Resonance Procedures: Health Effects and Safety Boca Raton, FL: CRC Press 183-196.
85. D.L. Zealear, K.C. Garren, R.J. Rodriguez, J.H. Reyes, S. Huang, M.R. Dokmeci, et al. (2001) The biocompatibility, integrity, and positional stability of an injectable microstimulator for reanimation of the paralyzed larynx. IEEE Trans. Biomed. Eng. 48 890-897.