{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T02:12:30Z","timestamp":1790734350725,"version":"4.1.0"},"reference-count":74,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2022,12,31]],"date-time":"2022-12-31T00:00:00Z","timestamp":1672444800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"MUMC+"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Audiology Research"],"abstract":"<jats:p>Background: Chronic tinnitus can have an immense impact on quality of life. Despite recent treatment advances, many tinnitus patients remain refractory to them. Preclinical and clinical evidence suggests that deep brain stimulation (DBS) is a promising treatment to suppress tinnitus. In rats, it has been shown in multiple regions of the auditory pathway that DBS can have an alleviating effect on tinnitus. The thalamic medial geniculate body (MGB) takes a key position in the tinnitus network, shows pathophysiological hallmarks of tinnitus, and is readily accessible using stereotaxy. Here, a protocol is described to evaluate the safety and test the therapeutic effects of DBS in the MGB in severe tinnitus sufferers. Methods: Bilateral DBS of the MGB will be applied in a future study in six patients with severe and refractory tinnitus. A double-blinded, randomized 2 \u00d7 2 crossover design (stimulation ON and OFF) will be applied, followed by a period of six months of open-label follow-up. The primary focus is to assess safety and feasibility (acceptability). Secondary outcomes assess a potential treatment effect and include tinnitus severity measured by the Tinnitus Functional Index (TFI), tinnitus loudness and distress, hearing, cognitive and psychological functions, quality of life, and neurophysiological characteristics. Discussion: This protocol carefully balances risks and benefits and takes ethical considerations into account. This study will explore the safety and feasibility of DBS in severe refractory tinnitus, through extensive assessment of clinical and neurophysiological outcome measures. Additionally, important insights into the underlying mechanism of tinnitus and hearing function might be revealed. Trial registration: ClinicalTrials.gov NCT03976908 (6 June 2019).<\/jats:p>","DOI":"10.3390\/audiolres13010005","type":"journal-article","created":{"date-parts":[[2023,1,2]],"date-time":"2023-01-02T04:56:27Z","timestamp":1672635387000},"page":"49-63","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A Protocol to Investigate Deep Brain Stimulation for Refractory Tinnitus: From Rat Model to the Set-Up of a Human Pilot Study"],"prefix":"10.3390","volume":"13","author":[{"given":"Gusta","family":"van Zwieten","sequence":"first","affiliation":[{"name":"School for Mental Health and Neuroscience (MHeNS), Maastricht University, 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3394-2865","authenticated-orcid":false,"given":"Jana V. P.","family":"Devos","sequence":"additional","affiliation":[{"name":"School for Mental Health and Neuroscience (MHeNS), Maastricht University, 6229 ER Maastricht, The Netherlands"},{"name":"Department of Neurosurgery, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"},{"name":"Department of Ear Nose and Throat\/Head and Neck Surgery, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonja A.","family":"Kotz","sequence":"additional","affiliation":[{"name":"Faculty of Psychology and Neuroscience, Department of Neuropsychology & Psychopharmacology, Maastricht University, 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Ackermans","sequence":"additional","affiliation":[{"name":"School for Mental Health and Neuroscience (MHeNS), Maastricht University, 6229 ER Maastricht, The Netherlands"},{"name":"Department of Neurosurgery, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pia","family":"Brinkmann","sequence":"additional","affiliation":[{"name":"Faculty of Psychology and Neuroscience, Department of Neuropsychology & Psychopharmacology, Maastricht University, 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lobke","family":"Dauven","sequence":"additional","affiliation":[{"name":"Department of Ear Nose and Throat\/Head and Neck Surgery, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6311-6866","authenticated-orcid":false,"given":"Erwin L. J.","family":"George","sequence":"additional","affiliation":[{"name":"School for Mental Health and Neuroscience (MHeNS), Maastricht University, 6229 ER Maastricht, The Netherlands"},{"name":"Department of Ear Nose and Throat\/Head and Neck Surgery, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. Miranda L.","family":"Janssen","sequence":"additional","affiliation":[{"name":"Department of Methodology and Statistics, School for Public Health and Primary Care, Maastricht University, 6229 HA Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Kremer","sequence":"additional","affiliation":[{"name":"Department of Ear Nose and Throat\/Head and Neck Surgery, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten","family":"Leue","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychology, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Schwartze","sequence":"additional","affiliation":[{"name":"Faculty of Psychology and Neuroscience, Department of Neuropsychology & Psychopharmacology, Maastricht University, 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasin","family":"Temel","sequence":"additional","affiliation":[{"name":"School for Mental Health and Neuroscience (MHeNS), Maastricht University, 6229 ER Maastricht, The Netherlands"},{"name":"Department of Neurosurgery, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasper V.","family":"Smit","sequence":"additional","affiliation":[{"name":"Department of Ear Nose and Throat\/Head and Neck Surgery, Zuyderland, 6419 PC Heerlen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0030-7224","authenticated-orcid":false,"given":"Marcus L. F.","family":"Janssen","sequence":"additional","affiliation":[{"name":"School for Mental Health and Neuroscience (MHeNS), Maastricht University, 6229 ER Maastricht, The Netherlands"},{"name":"Department of Clinical Neurophysiology, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,12,31]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1204","DOI":"10.1044\/1092-4388(2005\/084)","article-title":"General review of tinnitus: Prevalence, mechanisms, effects, and management","volume":"48","author":"Henry","year":"2005","journal-title":"J Speech Lang. Hear. Res."},{"key":"ref_2","unstructured":"(2022, December 01). American National Health and Nutrition Examination Survey, Audiometry section (AUQ_G). 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