{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T16:50:11Z","timestamp":1787503811109,"version":"build-2736575974"},"reference-count":34,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n Animal models have shown altered dorsal cochlear nucleus circuitry in animals that develop tinnitus; however, precise treatment using bisensory (auditory and somatosensory) stimuli can reverse altered neural patterns and lessen tinnitus.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To confirm and extend the findings of a pilot study, which suggested an increased efficacy of bisensory stimulation, to a clinical trial with a greater duration and greater number of participants.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This double-blind, crossover, single-center randomized clinical trial was conducted from March 2019, with a 3-month follow-up per participant ending in July 2022. Eligible adults were recruited from the University of Michigan Health System in Ann Arbor, Michigan. Eligibility criteria included bothersome tinnitus (Tinnitus Functional Index [TFI] score, \u226517 points), somatic tinnitus, normal to moderate hearing loss, and no other tinnitus treatments in the 6 months prior to the trial. Included participants were randomized to either treatment group 1, which received active (bisensory) treatment, or group 2, which received the control (auditory-only) treatment. Results were analyzed using intent-to-treat (ITT) and per protocol (PP) populations.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Precisely timed bisensory (combined auditory and somatosensory) treatment was delivered through a portable, custom, take-home device that was provided to each participant for daily, at-home treatments. Group 1 participants received 30 minutes per day of the bisensory treatment for 6 weeks, followed by a 6-week washout phase, and then 30 minutes per day of the auditory-only treatment followed by a second 6-week washout phase. Group 2 participants received the auditory-only treatment first, followed by a washout phase, and then the bisensory treatment followed by a second washout phase.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Primary end points were changes in TFI score and tinnitus loudness level from baseline through week 6 and week 12.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 337 screened individuals, 99 (mean [SD] age, 47 [12.7] years; 59 males [60%]; 85 with non-Hispanic White [86%] race and ethnicity) were enrolled into the study and randomized to treatment group 1 (n\u2009=\u200949) or group 2 (n\u2009=\u200950). The active but not the control treatment resulted in clinically significant decreases in TFI scores at week 6 of phase 1 (ITT population: \u201312.0 [95% CI, \u201316.9 to \u20137.9] points;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001; PP population: \u201313.2 [95% CI, \u201316.0 to \u201310.5] points;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Decreases in tinnitus loudness level were greater than 6 dB sensation level (SL; &amp;gt;half as loud) at week 6 for the bisensory treatment group, with little effect for the auditory-only treatment control group at week 6 of phase 1 (ITT population: \u20135.8 [95% CI, \u20139.5 to \u20132.2] dB;\n P<\/jats:italic>\n \u2009=\u2009.08; PP population: \u20137.2 [95% CI, \u201311.4 to \u20133.1] dB;\n P<\/jats:italic>\n \u2009=\u2009.03), and up to 11 dB SL at week 12 of phase 2 (ITT population: \u201310.9 [95% CI, \u201315.2 to \u20136.5] dB;\n P<\/jats:italic>\n \u2009=\u2009.001; PP population: \u201314.1 [95% CI, \u201318.4 to \u20139.8] dB;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Decreased tinnitus loudness level and TFI scores extended into the washout phase, indicating a prolonged treatment effect.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n This trial found that precisely timed bisensory treatment using stimuli and timing developed in a validated animal model was effective for adults with somatic tinnitus. Prolonged reduction in tinnitus symptoms can result from using an extended treatment duration.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT03621735<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2023.15914","type":"journal-article","created":{"date-parts":[[2023,6,2]],"date-time":"2023-06-02T11:33:44Z","timestamp":1685705624000},"page":"e2315914","source":"Crossref","is-referenced-by-count":20,"title":["Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts"],"prefix":"10.1001","volume":"6","author":[{"given":"Gerilyn R.","family":"Jones","sequence":"first","affiliation":[{"name":"Kresge Hearing Research Institute, Department of Otolaryngology, University of Michigan, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T.","family":"Martel","sequence":"additional","affiliation":[{"name":"Kresge Hearing Research Institute, Department of Otolaryngology, University of Michigan, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Travis L.","family":"Riffle","sequence":"additional","affiliation":[{"name":"Kresge Hearing Research Institute, Department of Otolaryngology, University of Michigan, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josh","family":"Errickson","sequence":"additional","affiliation":[{"name":"Consulting for Statistics, Computing and Analytics Research, University of Michigan, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline R.","family":"Souter","sequence":"additional","affiliation":[{"name":"Kresge Hearing Research Institute, Department of Otolaryngology, University of Michigan, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory J.","family":"Basura","sequence":"additional","affiliation":[{"name":"Kresge Hearing Research Institute, Department of Otolaryngology, University of Michigan, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Stucken","sequence":"additional","affiliation":[{"name":"Kresge Hearing Research Institute, Department of Otolaryngology, University of Michigan, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kara C.","family":"Schvartz-Leyzac","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head and Neck Surgery, Medical University of South Carolina, Charleston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan E.","family":"Shore","sequence":"additional","affiliation":[{"name":"Kresge Hearing Research Institute, Department of Otolaryngology, University of Michigan, Ann Arbor"},{"name":"Department of Biomedical Engineering, University of Michigan, Ann Arbor"},{"name":"Department of Molecular and Integrative Physiology, University of Michigan, Ann 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