Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans

Scientific Reports

Volumn 7, Issue 1, 2017, Pages

  Tyler, Richard ^a   Cacace, Anthony ^b   Stocking, Christina ^c   Tarver, Brent ^d   Engineer, Navzer ^d   Martin, Jeffrey ^e   Deshpande, Aniruddha ^f   Stecker, Nancy ^c   Pereira, Melissa ^c   Kilgard, Michael ^e   Burress, Chester ^d   Pierce, David ^d   Rennaker, Robert ^e   Vanneste, Sven ^e  

^a UNIVERSITY OF IOWA   (United States)

^b WAYNE STATE UNIVERSITY   (United States)

^c UNIVERSITY AT BUFFALO   (United States)

^d MicroTransponder Inc   (United States)

^e UNIVERSITY OF TEXAS AT DALLAS   (United States)

^f HOFSTRA UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; MALE; MIDDLE AGED; MULTICENTER STUDY; PILOT STUDY; PROCEDURES; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SOUND; TINNITUS; TREATMENT OUTCOME; UNITED STATES; VAGUS NERVE STIMULATION;

DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PILOT PROJECTS; PROSPECTIVE STUDIES; SOUND; TINNITUS; TREATMENT OUTCOME; UNITED STATES; VAGUS NERVE STIMULATION;

EID: 85029645698     PISSN: None     EISSN: 20452322     Source Type: Journal    
DOI: 10.1038/s41598-017-12178-w     Document Type: Article

References (53)

1. Bhatt, J. M., Lin, H. W. & Bhattacharyya, N. Prevalence, Severity, Exposures, and Treatment Patterns of Tinnitus in the United States. JAMA Otolaryngol. Neck Surg. 92697, 1-7 (2016).
2. Langguth, B. & Landgrebe, M. Tinnitus and depression. Textb. Tinnitus 12, 493-498 (2011).
3. Pattyn, T. et al. Tinnitus and anxiety disorders: A review. Hear. Res. 1-11 (2015).
4. Tyler, R. et al. Development and validation of the tinnitus primary function questionnaire. Am. J. Audiol. 23, 260-272 (2014).
5. Hoare, D. J., Kowalkowski, V. L., Kang, S. & Hall, D. A. Systematic review and meta-analyses of randomized controlled trials examining tinnitus management. Laryngoscope 121, 1555-1564 (2011).
6. Jastreboff, P. J. & Hazell, J. W. A neurophysiological approach to tinnitus: clinical implications. Br. J. Audiol. 27, 7-17 (1993).
7. Mohr, A. Your Life and Tinnitus in The Consumer Handbook on Tinnitus (ed. Tyler, R.) (Auricle Inc, 2008).
8. Searchfield, G. Hearing Aids and Tinnitus in Tinnitus Treatment Clinical Protocols (ed. Tyler, R.) 161-75 (Thieme, 2005).
9. Tyler, R., Stocking, C., Secor, C. & Slattery, W. H. Amplitude modulated S-Tones can be superior to noise for tinnitus reduction. Am. J. Audiol. 23, 303-308 (2014).
10. Tyler, R. S., Noble, W., Coelho, C. B. & Ji, H. Tinnitus Retraining Therapy: Mixing Point and Total Masking Are Equally Effective. Ear Hear. 33, 588-594 (2012).
11. Andersson, G. & Kaldo, V. Internet-Based Cognitive Behavioral Therapy for Tinnitus. Online 60, 171-178 (2004).
12. Sweetow, R. W. Cognitive aspects of tinnitus patient management. Ear Hear. 7, 390-396 (1986).
13. Tyler, R. S., Gogel, S. A. & Gehringer, A. K. Tinnitus activities treatment. Prog. Brain Res. 166, 425-434 (2007).
14. Dauman, R. & Tyler, R. In Tinnitus 91: Proceedings of the Fourth International Tinnitus Seminar, Bordeaux, France. August 27-30, 1991 225-229 (1992).
15. Tyler, R. S. N. Models, P. Models, and Treatments for Tinnitus. Tinnitus Treat. Clin. Protoc. 1-22 (2006).
16. Preece, J. P., Tyler, R. S. & Noble, W. The management of tinnitus. Geriatrics and Aging 6, 22-28 (2003).
17. Eggermont, J. J. & Roberts, L. E. The Neuroscience of Tinnitus: Understanding Abnormal and Normal Auditory Perception. Front. Syst. Neurosci. 6, 1-4 (2012).
18. Bauer, C. A., Turner, J. G., Caspary, D. M., Myers, K. S. & Brozoski, T. J. Tinnitus and inferior colliculus activity in chinchillas related to three distinct patterns of cochlear trauma. J. Neurosci. Res. 86, 2564-2578 (2008).
19. Eggermont, J. J. Central tinnitus. Auris. Nasus. Larynx 30(Suppl), S7-12 (2003).
20. Holt, A. G., Bissig, D., Mirza, N., Rajah, G. & Berkowitz, B. Evidence of key tinnitus-related brain regions documented by a unique combination of manganese-enhanced MRI and acoustic startle reflex testing. PLoS One 5, e14260 (2010).
21. Kaltenbach, J. A. The dorsal cochlear nucleus as a contributor to tinnitus: mechanisms underlying the induction of hyperactivity. Prog. Brain Res. 166, 89-106 (2007).
22. Noreña, A. J. & Eggermont, J. J. Changes in spontaneous neural activity immediately after an acoustic trauma: Implications for neural correlates of tinnitus. Hear. Res. 183, 137-153 (2003).
23. Eggermont, J. J. Tinnitus and neural plasticity (Tonndorf lecture at XIth International Tinnitus Seminar, Berlin, 2014). Hear. Res. 319, 1-11 (2015).
24. Eggermont, J. J. & Roberts, L. E. Tinnitus: animal models and findings in humans. Cell Tissue Res. 361, 311-36 (2015).
25. Engineer, N. D. et al. Reversing pathological neural activity using targeted plasticity Nature 470, 101-4 (2011).
26. Engineer, N. D., Møller, A. R. & Kilgard, M. P. Directing neural plasticity to understand and treat tinnitus. Hear. Res. 295, 58-66 (2013).
27. Hays, S. A., Rennaker, R. L. & Kilgard, M. P. Targeting plasticity with vagus nerve stimulation to treat neurological disease. Prog. Brain Res. 207, 275-299 (2013).
28. De Ridder, D., Vanneste, S., Engineer, N. D. & Kilgard, M. P. Safety and efficacy of vagus nerve stimulation paired with tones for the treatment of tinnitus: A case series. Neuromodulation 17, 170-179 (2014).
29. Khedr, E. M., Rothwell, J. C., Ahmed, M. A. & El-Atar, A. Effect of daily repetitive transcranial magnetic stimulation for treatment of tinnitus: comparison of different stimulus frequencies. J. Neurol. Neurosurg. Psychiatry 79, 212-215 (2008).
30. Zeman, F. et al. Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? Otolaryngol.-Head Neck Surg. 145, 282-287 (2011).
31. Meikle, M. B. et al. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. [Erratum appears in Ear Hear. 2012 May;33(3):443]. Ear Hear. 33, 153-176 (2012).
32. Chen, S.-P. et al. Vagus Nerve Stimulation Inhibits Cortical Spreading Depression. Pain (2015).
33. Oldani, L., Dell'Osso, B. & Altamura, A. C. Long-term effects of vagus nerve stimulation in treatment-resistant depression: A 5-year follow up case series. Brain Stimul. 8, 1229-1230 (2015).
34. Conway, C. R. et al. Cerebral blood flow changes during vagus nerve stimulation for depression. Psychiatry Res. - Neuroimaging 146, 179-184 (2006).
35. Golm, D., Schmidt-Samoa, C., Dechent, P. & Kröner-Herwig, B. Neural correlates of tinnitus related distress: An fMRI-study. Hear. Res. 295, 87-99 (2013).
36. Joos, K., van neste, S. & de Ridder, D. Disentangling depression and distress networks in the tinnitus brain. PLoS One 7, e40544 (2012).
37. Kosel, M., Brockmann, H., Frick, C., Zobel, A. & Schlaepfer, T. E. Chronic vagus nerve stimulation for treatment-resistant depression increases regional cerebral blood flow in the dorsolateral prefrontal cortex. Psychiatry Res. 191, 153-159 (2011).
38. Vanneste, S. et al. The neural correlates of tinnitus-related distress. Neuroimage 52, 470-480 (2010).
39. Staecker, H. et al. Selecting appropriate dose regimens for AM-101 in the intratympanic treatment of acute inner ear tinnitus. Audiol. Neurotol. 20, 172-182 (2015).
40. van de Heyning, P. et al. Efficacy and Safety of AM-101 in the Treatment of Acute Inner Ear Tinnitus V A Double-Blind, Randomized, Placebo-Controlled Phase II Study. Otol. 101 (2014).
41. Hoare, D. J., Edmondson-Jones, M., Gander, P. E. & Hall, D. A. Agreement and reliability of tinnitus loudness matching and pitch likeness rating. PLoS One 9, e114553 (2014).
42. Grimonprez, A., Raedt, R., Baeken, C., Boon, P. & Vonck, K. Neuroscience and Biobehavioral Reviews The antidepressant mechanism of action of vagus nerve stimulation: Evidence from preclinical studies. Neurosci. Biobehav. Rev. 56, 26-34 (2015).
43. Vonck, K. et al. Neuroscience and Biobehavioral Reviews Vagus nerve stimulation. 25 years later! What do we know about the effects on cognition? Neurosci. Biobehav. Rev. 45, 63-71 (2014).
44. Borland, M. et al. Cortical map plasticity as a function of vagus nerve stimulation intensity. Brain Stimul. 9, 117-23 (2016).
45. Usami, K., Kawai, K., Sonoo, M. & Saito, N. Scalp-recorded evoked potentials as a marker for afferent nerve impulse in clinical vagus nerve stimulation. Brain Stimul. 6, 615-623 (2013).
46. Dobie, R. Clinical Trials and Drug Therapy for tinnitus in Tinnitus: Theory and Management (ed. Snow, J) 266-77 (2004).
47. Tyler, R. et al. Identifying tinnitus subgroups with cluster analysis. Am. J. Audiol. 17, (2008).
48. Tyler, R. The psychoacoustical measurement of tinnitus in Tinnitus Handbook (ed. Tyler, R.) 149-79 (Singular Publishing Group, 2000).
49. Tyler, R. Psychoacoustical measurement of tinnitus for treatment evaluations in New Dimensions in Otorhinolaryngology Head and Neck Surgery (ed. Myers) 455-58 (Elsevier Publishing, 1985).
50. Beck, A., Steer, R., Ball, R. & Ranieri, W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J. Pers. Assess. 67, 588-597 (1996).
51. Spielberger C., Gorsuch R., Lushene R., Vagg P. & Jacobs G. Manual for the state-trait anxiety scale. Consulting Psychologists. SF-12 (1983).
52. Ware, J., Kosinski, M. & Keller, S. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 34, 220-33 (1996).
53. Folmer, R. L. et al. Repetitive Transcranial Magnetic Stimulation Treatment for Chronic Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol. Head Neck Surg. 141, 716-22 (2015).