Cargando…
Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device
BACKGROUND: Chronic tinnitus affects millions of people globally and constitutes the most commonly compensated disability among military service members in the United States. Existing treatment options largely surround helping patients cope with their disease as opposed to directly suppressing tinni...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8800213/ https://www.ncbi.nlm.nih.gov/pubmed/35093126 http://dx.doi.org/10.1186/s12967-022-03271-4 |
_version_ | 1784642211289235456 |
---|---|
author | Marinelli, John P. Anzalone, C. Lane Prummer, Christoph M. Poling, Gayla L. Staab, Jeffrey P. Tombers, Nicole M. Lohse, Christine M. Carlson, Matthew L. |
author_facet | Marinelli, John P. Anzalone, C. Lane Prummer, Christoph M. Poling, Gayla L. Staab, Jeffrey P. Tombers, Nicole M. Lohse, Christine M. Carlson, Matthew L. |
author_sort | Marinelli, John P. |
collection | PubMed |
description | BACKGROUND: Chronic tinnitus affects millions of people globally and constitutes the most commonly compensated disability among military service members in the United States. Existing treatment options largely surround helping patients cope with their disease as opposed to directly suppressing tinnitus perception. The current study investigated the efficacy of electrical stimulation of the cochlea on chronic disabling tinnitus. METHODS: In this single-arm, open-label clinical trial, 22 adult subjects with severe-range asymmetric or unilateral non-pulsatile tinnitus underwent electrical stimulation of the cochlea through use of an extra-cochlear electrode positioned on the cochlear promontory. Each subject underwent 3 stimulation treatments over 3 weeks at 7-day intervals. Tinnitus severity was determined by Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus Visual Analog Scale (VAS). Inclusion criteria required subjects have no worse than moderate sensorineural hearing loss determined by pre-enrollment audiometric testing. The primary outcome was nadir post-treatment THI scores, obtained at seven timepoints following electrical stimulation, with clinically significant improvement defined as a decrease of ≥ 7. RESULTS: All 22 (100%) subjects experienced clinically significant improvement in the THI during the study period with a mean decrease in scores of − 31 (95% CI − 38 to − 25) from a baseline of 48. Twenty (91%) experienced clinically significant improvement detectable on at least two of the three tinnitus survey instruments and 17 (77%) experienced clinically significant improvement detectable on all three survey instruments (i.e., THI, TFI, and VAS). Eight (36%) subjects reported either complete (THI of 0; n = 3) or near-complete (THI 1–4; n = 5) suppression of their tinnitus following a stimulation session. Thirteen (59%) subjects reported a nadir following stimulation at or below the threshold for “no or slight handicap” on the THI (≤ 16). No adverse events were observed. CONCLUSIONS: These findings establish the foundation for the development of an extra-cochlear implantable device that delivers electrical stimulation to the cochlea for the treatment of disabling tinnitus. For patients considering device implantation, trans-tympanic cochlear promontory stimulation can facilitate patient selection. Trial Registration ClinicalTrials.gov Identifier: NCT03759834. URL: https://clinicaltrials.gov/ct2/show/NCT03759834 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12967-022-03271-4. |
format | Online Article Text |
id | pubmed-8800213 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-88002132022-02-02 Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device Marinelli, John P. Anzalone, C. Lane Prummer, Christoph M. Poling, Gayla L. Staab, Jeffrey P. Tombers, Nicole M. Lohse, Christine M. Carlson, Matthew L. J Transl Med Research BACKGROUND: Chronic tinnitus affects millions of people globally and constitutes the most commonly compensated disability among military service members in the United States. Existing treatment options largely surround helping patients cope with their disease as opposed to directly suppressing tinnitus perception. The current study investigated the efficacy of electrical stimulation of the cochlea on chronic disabling tinnitus. METHODS: In this single-arm, open-label clinical trial, 22 adult subjects with severe-range asymmetric or unilateral non-pulsatile tinnitus underwent electrical stimulation of the cochlea through use of an extra-cochlear electrode positioned on the cochlear promontory. Each subject underwent 3 stimulation treatments over 3 weeks at 7-day intervals. Tinnitus severity was determined by Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus Visual Analog Scale (VAS). Inclusion criteria required subjects have no worse than moderate sensorineural hearing loss determined by pre-enrollment audiometric testing. The primary outcome was nadir post-treatment THI scores, obtained at seven timepoints following electrical stimulation, with clinically significant improvement defined as a decrease of ≥ 7. RESULTS: All 22 (100%) subjects experienced clinically significant improvement in the THI during the study period with a mean decrease in scores of − 31 (95% CI − 38 to − 25) from a baseline of 48. Twenty (91%) experienced clinically significant improvement detectable on at least two of the three tinnitus survey instruments and 17 (77%) experienced clinically significant improvement detectable on all three survey instruments (i.e., THI, TFI, and VAS). Eight (36%) subjects reported either complete (THI of 0; n = 3) or near-complete (THI 1–4; n = 5) suppression of their tinnitus following a stimulation session. Thirteen (59%) subjects reported a nadir following stimulation at or below the threshold for “no or slight handicap” on the THI (≤ 16). No adverse events were observed. CONCLUSIONS: These findings establish the foundation for the development of an extra-cochlear implantable device that delivers electrical stimulation to the cochlea for the treatment of disabling tinnitus. For patients considering device implantation, trans-tympanic cochlear promontory stimulation can facilitate patient selection. Trial Registration ClinicalTrials.gov Identifier: NCT03759834. URL: https://clinicaltrials.gov/ct2/show/NCT03759834 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12967-022-03271-4. BioMed Central 2022-01-29 /pmc/articles/PMC8800213/ /pubmed/35093126 http://dx.doi.org/10.1186/s12967-022-03271-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Marinelli, John P. Anzalone, C. Lane Prummer, Christoph M. Poling, Gayla L. Staab, Jeffrey P. Tombers, Nicole M. Lohse, Christine M. Carlson, Matthew L. Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device |
title | Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device |
title_full | Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device |
title_fullStr | Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device |
title_full_unstemmed | Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device |
title_short | Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device |
title_sort | electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8800213/ https://www.ncbi.nlm.nih.gov/pubmed/35093126 http://dx.doi.org/10.1186/s12967-022-03271-4 |
work_keys_str_mv | AT marinellijohnp electricalstimulationofthecochleafortreatmentofchronicdisablingtinnitusanopenlabeltrialtowardsthedevelopmentofanimplantabledevice AT anzaloneclane electricalstimulationofthecochleafortreatmentofchronicdisablingtinnitusanopenlabeltrialtowardsthedevelopmentofanimplantabledevice AT prummerchristophm electricalstimulationofthecochleafortreatmentofchronicdisablingtinnitusanopenlabeltrialtowardsthedevelopmentofanimplantabledevice AT polinggaylal electricalstimulationofthecochleafortreatmentofchronicdisablingtinnitusanopenlabeltrialtowardsthedevelopmentofanimplantabledevice AT staabjeffreyp electricalstimulationofthecochleafortreatmentofchronicdisablingtinnitusanopenlabeltrialtowardsthedevelopmentofanimplantabledevice AT tombersnicolem electricalstimulationofthecochleafortreatmentofchronicdisablingtinnitusanopenlabeltrialtowardsthedevelopmentofanimplantabledevice AT lohsechristinem electricalstimulationofthecochleafortreatmentofchronicdisablingtinnitusanopenlabeltrialtowardsthedevelopmentofanimplantabledevice AT carlsonmatthewl electricalstimulationofthecochleafortreatmentofchronicdisablingtinnitusanopenlabeltrialtowardsthedevelopmentofanimplantabledevice |