Evaluating the Efficacy and Underlying Mechanisms of Acupuncture for Chronic Subjective Tinnitus Using Functional Near-Infrared Spectroscopy: Study Protocol for a Randomized Controlled Trial

References

• Baguley D, McFerran D, Hall D. Tinnitus. Lancet. 2013;382(9904):1600–1607. doi:10.1016/S0140-6736(13)60142-7
   PubMed Web of Science ®Google Scholar
• McCormack A, Edmondson-Jones M, Somerset S, et al. A systematic review of the reporting of tinnitus prevalence and severity. Hear Res. 2016;337:70–79. doi:10.1016/j.heares.2016.05.009
   PubMed Web of Science ®Google Scholar
• Kang D-W, Kim -S-S, Park D-C, Kim S-H, Yeo S-G. Objective and measurable biomarkers in chronic subjective tinnitus. Int J Mol Sci. 2021;22(12):6619. doi:10.3390/ijms22126619
   PubMed Web of Science ®Google Scholar
• Wang K, Tang D, Ma J, Sun S. Auditory neural plasticity in tinnitus mechanisms and management. Neural Plasticity. 2020;2020:7438461.
   PubMed Web of Science ®Google Scholar
• Shore SE, Roberts LE, Langguth B. Maladaptive plasticity in tinnitus--triggers, mechanisms and treatment. Nat Rev Neurol. 2016;12(3):150–160. doi:10.1038/nrneurol.2016.12
   PubMed Web of Science ®Google Scholar
• Noreña AJ, Eggermont JJ. Changes in spontaneous neural activity immediately after an acoustic trauma: implications for neural correlates of tinnitus. Hear Res. 2003;183(1–2):137–153. doi:10.1016/S0378-5955(03)00225-9
   PubMed Web of Science ®Google Scholar
• San Juan J, Hu X-S, Issa M, et al. Tinnitus alters resting state functional connectivity (RSFC) in human auditory and non-auditory brain regions as measured by functional near-infrared spectroscopy (fNIRS). PLoS One. 2017;12(6):e0179150. doi:10.1371/journal.pone.0179150
   PubMed Web of Science ®Google Scholar
• De Ridder D, Elgoyhen AB, Romo R, Langguth B. Phantom percepts: tinnitus and pain as persisting aversive memory networks. Proc Natl Acad Sci USA. 2011;108(20):8075–8080. doi:10.1073/pnas.1018466108
   PubMed Web of Science ®Google Scholar
• Luetzenberg FS, Babu S, Seidman MD. Alternative treatments of tinnitus. Otolaryngol Clin North Am. 2020;53(4):637–650. doi:10.1016/j.otc.2020.03.011
   PubMed Web of Science ®Google Scholar
• Ismail AMA, Ali SM, Ghuiba K, et al. Autonomic functions, tinnitus annoyance and loudness, and quality of life: randomized-controlled responses to bee-humming (vibrational) respiratory training in tinnitus elderly. Complement Ther Clin Pract. 2022;48:101611. doi:10.1016/j.ctcp.2022.101611
   PubMed Web of Science ®Google Scholar
• Kuzucu I, Karaca O. Acupuncture treatment in patients with chronic subjective tinnitus: a prospective, randomized study. Med Acupunct. 2020;32(1):24–28. doi:10.1089/acu.2019.1367
   PubMed Web of Science ®Google Scholar
• Ismail AMA, Aly ME, Elfahl AA. Effect of acupuncture on tinnitus severity index in the elderly with non-pulsating tinnitus. Physioth Quart. 2022;30:57–60. doi:10.5114/pq.2021.108662
   Google Scholar
• Ali Ismail AM. Lipid profile response to acupuncture in obese patients with subjective tinnitus: a randomized controlled trial. J Acupunct Meridian Stud. 2023;16:11–19. doi:10.51507/j.jams.2023.16.1.11
   PubMed Web of Science ®Google Scholar
• Liu F, Han X, Li Y, Yu S. Acupuncture in the treatment of tinnitus: a systematic review and meta-analysis. European archives of oto-rhino-laryngology: official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS): affiliated with the German society for oto-rhino-laryngology. Head Neck Surg. 2016;273(2):285–294.
   Google Scholar
• He M, Li X, Liu Y, et al. Electroacupuncture for tinnitus: a systematic review. PLoS One. 2016;11:3.
   Web of Science ®Google Scholar
• Kim JI, Choi JY, Lee DH, Choi TY, Lee MS, Ernst E. Ernst E: acupuncture for the treatment of tinnitus: a systematic review of randomized clinical trials. BMC Complement Altern Med. 2012;12:97. doi:10.1186/1472-6882-12-97
   PubMed Web of Science ®Google Scholar
• Wu Q, Wang J, Han D, Hu H, Gao H. Efficacy and safety of acupuncture and moxibustion for primary tinnitus: a systematic review and meta-analysis. Am J Otolaryngol. 2023;44(3):103821. doi:10.1016/j.amjoto.2023.103821
   PubMed Web of Science ®Google Scholar
• Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. NeuroImage. 2012;63(2):921–935. doi:10.1016/j.neuroimage.2012.03.049
   PubMed Web of Science ®Google Scholar
• Pinti P, Tachtsidis I, Hamilton A, et al. The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Ann N Y Acad Sci. 2020;1464(1):5–29. doi:10.1111/nyas.13948
   PubMed Web of Science ®Google Scholar
• Huang B, Wang X, Sun Q, Xiong G. Advances in the Application of Functional Near-Infrared Spectroscopy (fNIRS) in Tinnitus. Chin J Otol. 2022;20:824–828.
   Google Scholar
• Shoushtarian M, Alizadehsani R, Khosravi A, et al. Objective measurement of tinnitus using functional near-infrared spectroscopy and machine learning. PLoS One. 2020;15(11):e0241695. doi:10.1371/journal.pone.0241695
   PubMed Web of Science ®Google Scholar
• Issa M, Bisconti S, Kovelman I, Kileny P, Basura GJ. Human auditory and adjacent nonauditory cerebral cortices are hypermetabolic in tinnitus as measured by functional near-infrared spectroscopy (fNIRS). Neural Plast. 2016;2016:1–13. doi:10.1155/2016/7453149
   Web of Science ®Google Scholar
• San Juan JD, Zhai T, Ash-Rafzadeh A, et al. Tinnitus and auditory cortex: using adapted functional near-infrared spectroscopy to measure resting-state functional connectivity. NeuroReport. 2021;32(1):66–75. doi:10.1097/WNR.0000000000001561
   PubMed Web of Science ®Google Scholar
• Schecklmann M, Giani A, Tupak S, Langguth B, Raab V. Functional near-infrared spectroscopy to probe state- and trait-like conditions in chronic tinnitus: a proof-of-principle study. Neural Plasticity. 2014;2014:894203.
   PubMed Web of Science ®Google Scholar
• Basura GJ, Hu XS, Juan JS, Tessier AM, Kovelman I. Human central auditory plasticity: a review of functional near-infrared spectroscopy (fNIRS) to measure cochlear implant performance and tinnitus perception. Laryngoscope Investig Otolaryngol. 2018;3(6):463–472. doi:10.1002/lio2.185
   PubMed Web of Science ®Google Scholar
• Yu X, Gong B, Yang H, et al. Effect of acupuncture treatment on cortical activation in patients with tinnitus: a functional near-infrared spectroscopy study. In: IEEE transactions on neural systems and rehabilitation engineering: a publication of the IEEE Engineering in Medicine and Biology Society; 2023.
   Google Scholar
• Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi:10.7326/0003-4819-158-3-201302050-00583
   PubMed Web of Science ®Google Scholar
• Tunkel DE, Bauer CA, Sun GH, et al. Clinical practice guideline: tinnitus executive summary. Otolaryngol Head Neck Surg. 2014;151(4):533–541. doi:10.1177/0194599814547475
   PubMed Web of Science ®Google Scholar
• Cima RFF, Mazurek B, Haider H, et al. A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment. HNO. 2019;67(S1):10–42. doi:10.1007/s00106-019-0633-7
   PubMedGoogle Scholar
• Jensen M, Hüttenrauch E, Schmidt J, Andersson G, Chavanon ML, Weise C. Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers. Trials. 2020;21(1):382. doi:10.1186/s13063-020-04309-y
   PubMed Web of Science ®Google Scholar
• MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. J Evid Based Med. 2010;3(3):140–155. doi:10.1111/j.1756-5391.2010.01086.x
   PubMedGoogle Scholar
• Song H, Chen L, Gao R, et al. Automatic schizophrenic discrimination on fNIRS by using complex brain network analysis and SVM. BMC Med Inform Decis Mak. 2017;17(Suppl 3):166. doi:10.1186/s12911-017-0559-5
   PubMedGoogle Scholar
• NIRS-KIT: a MATLAB toolbox for both resting-state and task fNIRS data analysis. Available from: https://pubmed.ncbi.nlm.nih.gov/33506071/. Accessed September 22, 2023.
   Google Scholar
• Newman CW, Sandridge SA, Jacobson GP. Psychometric adequacy of the Tinnitus Handicap Inventory (THI) for evaluating treatment outcome. J Am Acad Audiol. 1998;9(2):153–160.
   PubMedGoogle Scholar
• Manning C, Grush L, Thielman E, Roberts L, Henry JA. Comparison of tinnitus loudness measures: matching, rating, and scaling. Am J Audiol. 2019;28(1):137–143. doi:10.1044/2018_AJA-17-0115
   PubMed Web of Science ®Google Scholar
• Shidara J, Kodera K. 純音聴力検査(空気伝導と骨伝導の閾値テスト)[Pure-tone audiometry (air and bone conductive threshold test)]. Nihon Rinsho. 1997;55(1):466–468. Japanese.
   PubMedGoogle Scholar
• Thompson E. Hamilton Rating Scale for Anxiety (HAM-A). Occup Med. 2015;65(7):601. doi:10.1093/occmed/kqv054
   Google Scholar
• Elgoyhen AB, Langguth B, De Ridder D, Vanneste S. Tinnitus: perspectives from human neuroimaging. Nat Rev Neurosci. 2015;16(10):632–642. doi:10.1038/nrn4003
   PubMed Web of Science ®Google Scholar
• Chung KF, Yeung WF, Yu YM, Kwok CW, Zhang SP, Zhang ZJ. Adverse events related to acupuncture: development and testing of a rating scale. Clin J Pain. 2015;31(10):922–928. doi:10.1097/AJP.0000000000000189
   PubMed Web of Science ®Google Scholar
• Peuker E, Filler T. Guidelines for case reports of adverse events related to acupuncture. Acupunct Med. 2004;22(1):29–33. doi:10.1136/aim.22.1.29
   PubMedGoogle Scholar
• Wei Y, Zhang W, Li Y, et al. Acupuncture Treatment Decreased Temporal Variability of Dynamic Functional Connectivity in Chronic Tinnitus. Front Neurosci. 2021;15:737993. doi:10.3389/fnins.2021.737993
   PubMed Web of Science ®Google Scholar
• Fox MD, Raichle ME. Spontaneous fluctuations in brain activity observed with functional magnetic resonance imaging. Nat Rev Neurosci. 2007;8(9):700–711. doi:10.1038/nrn2201
   PubMed Web of Science ®Google Scholar
• Greicius M. Resting-state functional connectivity in neuropsychiatric disorders. Curr Opin Neurol. 2008;21(4):424–430. doi:10.1097/WCO.0b013e328306f2c5
   PubMed Web of Science ®Google Scholar
• Damoiseaux JS, Greicius MD. Greater than the sum of its parts: a review of studies combining structural connectivity and resting-state functional connectivity. Brain Struct Funct. 2009;213(6):525–533. doi:10.1007/s00429-009-0208-6
   PubMed Web of Science ®Google Scholar