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Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters

BACKGROUND: There is increasing evidence from animal and human studies that bimodal neuromodulation combining sound and electrical somatosensory stimulation of the tongue can induce extensive brain changes and treat tinnitus. OBJECTIVE: The main objectives of the proposed clinical study are to confi...

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Autores principales: Conlon, Brendan, Hamilton, Caroline, Hughes, Stephen, Meade, Emma, Hall, Deborah A, Vanneste, Sven, Langguth, Berthold, Lim, Hubert H
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789422/
https://www.ncbi.nlm.nih.gov/pubmed/31573942
http://dx.doi.org/10.2196/13176
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author Conlon, Brendan
Hamilton, Caroline
Hughes, Stephen
Meade, Emma
Hall, Deborah A
Vanneste, Sven
Langguth, Berthold
Lim, Hubert H
author_facet Conlon, Brendan
Hamilton, Caroline
Hughes, Stephen
Meade, Emma
Hall, Deborah A
Vanneste, Sven
Langguth, Berthold
Lim, Hubert H
author_sort Conlon, Brendan
collection PubMed
description BACKGROUND: There is increasing evidence from animal and human studies that bimodal neuromodulation combining sound and electrical somatosensory stimulation of the tongue can induce extensive brain changes and treat tinnitus. OBJECTIVE: The main objectives of the proposed clinical study are to confirm the efficacy, safety, and tolerability of treatment demonstrated in a previous large-scale study of bimodal auditory and trigeminal nerve (tongue) stimulation (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A1); evaluate the therapeutic effects of adjusting stimulation parameters over time; and determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes. METHODS: This study will be a prospective, randomized, double-blind, parallel-arm, comparative clinical trial of a 12-week treatment for tinnitus using a Conformité Européenne (CE)–marked device with a pre-post and 12-month follow-up design. Four treatment arms will be investigated, in which each arm consists of two different stimulation settings, with the first setting presented during the first 6 weeks and the second setting presented during the next 6 weeks of treatment. The study will enroll 192 participants, split in a ratio of 80:80:16:16 across the four arms. Participants will be randomized to one of four arms and stratified to minimize baseline variability in four categories: two separate strata for sound level tolerance (using loudness discomfort level as indicators for hyperacusis severity), high tinnitus symptom severity based on the Tinnitus Handicap Inventory (THI), and tinnitus laterality. The primary efficacy endpoints are within-arm changes in THI and Tinnitus Functional Index as well as between-arm changes in THI after 6 weeks of treatment for the full cohort and two subgroups of tinnitus participants (ie, one hyperacusis subgroup and a high tinnitus symptom severity subgroup). Additional efficacy endpoints include within-arm or between-arm changes in THI after 6 or 12 weeks of treatment and in different subgroups of tinnitus participants as well as at posttreatment assessments at 6 weeks, 6 months, and 12 months. Treatment safety, attrition rates, and compliance rates will also be assessed and reported. RESULTS: This study protocol was approved by the Tallaght University Hospital/St. James’s Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020. CONCLUSIONS: The findings of this study will be disseminated to relevant research, clinical, and health services and patient communities through publications in peer-reviewed journals and presentations at scientific and clinical conferences. TRIAL REGISTRATION: ClinicalTrials.gov NCT03530306; https://clinicaltrials.gov/ct2/show/NCT03530306 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13176
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spelling pubmed-67894222019-10-31 Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters Conlon, Brendan Hamilton, Caroline Hughes, Stephen Meade, Emma Hall, Deborah A Vanneste, Sven Langguth, Berthold Lim, Hubert H JMIR Res Protoc Protocol BACKGROUND: There is increasing evidence from animal and human studies that bimodal neuromodulation combining sound and electrical somatosensory stimulation of the tongue can induce extensive brain changes and treat tinnitus. OBJECTIVE: The main objectives of the proposed clinical study are to confirm the efficacy, safety, and tolerability of treatment demonstrated in a previous large-scale study of bimodal auditory and trigeminal nerve (tongue) stimulation (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A1); evaluate the therapeutic effects of adjusting stimulation parameters over time; and determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes. METHODS: This study will be a prospective, randomized, double-blind, parallel-arm, comparative clinical trial of a 12-week treatment for tinnitus using a Conformité Européenne (CE)–marked device with a pre-post and 12-month follow-up design. Four treatment arms will be investigated, in which each arm consists of two different stimulation settings, with the first setting presented during the first 6 weeks and the second setting presented during the next 6 weeks of treatment. The study will enroll 192 participants, split in a ratio of 80:80:16:16 across the four arms. Participants will be randomized to one of four arms and stratified to minimize baseline variability in four categories: two separate strata for sound level tolerance (using loudness discomfort level as indicators for hyperacusis severity), high tinnitus symptom severity based on the Tinnitus Handicap Inventory (THI), and tinnitus laterality. The primary efficacy endpoints are within-arm changes in THI and Tinnitus Functional Index as well as between-arm changes in THI after 6 weeks of treatment for the full cohort and two subgroups of tinnitus participants (ie, one hyperacusis subgroup and a high tinnitus symptom severity subgroup). Additional efficacy endpoints include within-arm or between-arm changes in THI after 6 or 12 weeks of treatment and in different subgroups of tinnitus participants as well as at posttreatment assessments at 6 weeks, 6 months, and 12 months. Treatment safety, attrition rates, and compliance rates will also be assessed and reported. RESULTS: This study protocol was approved by the Tallaght University Hospital/St. James’s Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020. CONCLUSIONS: The findings of this study will be disseminated to relevant research, clinical, and health services and patient communities through publications in peer-reviewed journals and presentations at scientific and clinical conferences. TRIAL REGISTRATION: ClinicalTrials.gov NCT03530306; https://clinicaltrials.gov/ct2/show/NCT03530306 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13176 JMIR Publications 2019-09-27 /pmc/articles/PMC6789422/ /pubmed/31573942 http://dx.doi.org/10.2196/13176 Text en ©Brendan Conlon, Caroline Hamilton, Stephen Hughes, Emma Meade, Deborah A Hall, Sven Vanneste, Berthold Langguth, Hubert H Lim. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.09.2019 https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Conlon, Brendan
Hamilton, Caroline
Hughes, Stephen
Meade, Emma
Hall, Deborah A
Vanneste, Sven
Langguth, Berthold
Lim, Hubert H
Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters
title Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters
title_full Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters
title_fullStr Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters
title_full_unstemmed Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters
title_short Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters
title_sort noninvasive bimodal neuromodulation for the treatment of tinnitus: protocol for a second large-scale double-blind randomized clinical trial to optimize stimulation parameters
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789422/
https://www.ncbi.nlm.nih.gov/pubmed/31573942
http://dx.doi.org/10.2196/13176
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