{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,8]],"date-time":"2026-08-08T22:48:23Z","timestamp":1786229303414,"version":"build-2736575974"},"reference-count":45,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec><jats:title>OBJECTIVE<\/jats:title><jats:p>The objective of this open-label, nonrandomized trial was to evaluate the efficacy and safety of bilateral caudate nucleus deep brain stimulation (DBS) for treatment-resistant tinnitus.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Six participants underwent DBS electrode implantation. One participant was removed from the study for suicidality unrelated to brain stimulation. Participants underwent a stimulation optimization period that ranged from 5 to 13 months, during which the most promising stimulation parameters for tinnitus reduction for each individual were determined. These individual optimal stimulation parameters were then used during 24 weeks of continuous caudate stimulation to reach the endpoint. The primary outcome for efficacy was the Tinnitus Functional Index (TFI), and executive function (EF) safety was a composite z-score from multiple neuropsychological tests (EF score). The secondary outcome for efficacy was the Tinnitus Handicap Inventory (THI); for neuropsychiatric safety it was the Frontal Systems Behavior Scale (FrSBe), and for hearing safety it was pure tone audiometry at 0.5, 1, 2, 3, 4, and 6 kHz and word recognition score (WRS). Other monitored outcomes included surgery- and device-related adverse events (AEs). Five participants provided full analyzable data sets. Primary and secondary outcomes were based on differences in measurements between baseline and endpoint.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>The treatment effect size of caudate DBS for tinnitus was assessed by TFI [mean (SE), 23.3 (12.4)] and THI [30.8 (10.4)] scores, both of which were statistically significant (Wilcoxon signed-rank test, 1-tailed; alpha = 0.05). Based on clinically significant treatment response categorical analysis, there were 3 responders determined by TFI (\u2265 13-point decrease) and 4 by THI (\u2265 20-point decrease) scores. Safety outcomes according to EF score, FrSBe, audiometric thresholds, and WRS showed no significant change with continuous caudate stimulation. Surgery-related and device-related AEs were expected, transient, and reversible. There was only one serious AE, a suicide attempt unrelated to caudate neuromodulation in a participant in whom stimulation was in the off mode for 2 months prior to the event.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>Bilateral caudate nucleus neuromodulation by DBS for severe, refractory tinnitus in this phase I trial showed very encouraging results. Primary and secondary outcomes revealed a highly variable treatment effect size and 60%\u201380% treatment response rate for clinically significant benefit, and no safety concerns. The design of a phase II trial may benefit from targeting refinement for final DBS lead placement to decrease the duration of the stimulation optimization period and to increase treatment effect size uniformity.<\/jats:p><jats:p>Clinical trial registration no.: NCT01988688 (clinicaltrials.gov).<\/jats:p><\/jats:sec>","DOI":"10.3171\/2019.4.jns19347","type":"journal-article","created":{"date-parts":[[2019,9,28]],"date-time":"2019-09-28T05:54:26Z","timestamp":1569650066000},"page":"992-1001","source":"Crossref","is-referenced-by-count":20,"title":["Phase I trial of caudate deep brain stimulation for treatment-resistant tinnitus"],"prefix":"10.3171","volume":"133","author":[{"given":"Steven W.","family":"Cheung","sequence":"first","affiliation":[{"name":"Department of Otolaryngology\u2013Head and Neck Surgery, UCSF;"},{"name":"Surgical Services, Veterans Affairs Health Care System, San Francisco;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline A.","family":"Racine","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, UCSF;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Henderson-Sabes","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head and Neck Surgery, UCSF;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carly","family":"Demopoulos","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, UCSF;"},{"name":"Department of Radiology and Biomedical Imaging, UCSF;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette M.","family":"Molinaro","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, UCSF;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Heath","sequence":"additional","affiliation":[{"name":"Surgical Services, Veterans Affairs Health Care System, San Francisco;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srikantan S.","family":"Nagarajan","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head and Neck Surgery, UCSF;"},{"name":"Department of Radiology and Biomedical Imaging, UCSF;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea L.","family":"Bourne","sequence":"additional","affiliation":[{"name":"Audiology and Speech Pathology Service, Veterans Affairs Health Care System, San Francisco; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John E.","family":"Rietcheck","sequence":"additional","affiliation":[{"name":"Audiology and Speech Pathology Service, Veterans Affairs Health Care System, San Francisco; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah S.","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurology, UCSF, San Francisco, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul S.","family":"Larson","sequence":"additional","affiliation":[{"name":"Surgical Services, Veterans Affairs Health Care System, San Francisco;"},{"name":"Department of Neurological Surgery, UCSF;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1","series-title":"Otologic Referral Criteria for Occupational Hearing Conservation Programs","author":"American Academy of Otolaryngology\u2013Head and Neck Surgery","year":"1997","unstructured":"American Academy of Otolaryngology\u2013Head and Neck Surgery: Otologic Referral Criteria for Occupational Hearing Conservation Programs. 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