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Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping

D’Arcy, Shona; Hamilton, Caroline; Hughes, Stephen; Hall, Deborah A.; Vanneste, Sven; Langguth, Berthold; Conlon, Brendan

Authors

Shona D’Arcy shona.darcy@neuromoddevices.com

Caroline Hamilton

Stephen Hughes

Deborah A. Hall deborah.hall@nottingham.ac.uk

Sven Vanneste

Berthold Langguth

Brendan Conlon



Abstract

Introduction: Tinnitus is the perception of sound in the absence of a corresponding external acoustic stimulus. Bi-modal neuromodulation is emerging as a promising treatment for this condition. The main objectives of this study are to investigate the relevance of inter-stimuli timing and the choice of auditory stimuli for a proprietary bi-modal (auditory and somatosensory) neuromodulation device and to explore whether specific subtypes of patients are differentially responsive to this novel intervention for reducing the symptoms of chronic tinnitus.
Methods and analysis: This is a two-site, randomised, triple-blind, exploratory study of a proprietary neuromodulation device with a pre-post and 12-month follow-up design. Three different bi-modal stimulation parameter sets will be examined. The study will enrol 342 patients, split 80:20 between two sites (Dublin, Ireland and Regensburg, Germany), to complete 12 weeks of treatment with the device. Patients will be allocated to one of three arms using a step-wise stratification according to four binary categories: tinnitus tonality, sound level tolerance (using Loudness Discomfort Level of

Journal Article Type Article
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 7
Article Number e018465
APA6 Citation D’Arcy, S., Hamilton, C., Hughes, S., Hall, D. A., Vanneste, S., Langguth, B., & Conlon, B. (in press). Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping. BMJ Open, 7, doi:10.1136/bmjopen-2017-018465
DOI https://doi.org/10.1136/bmjopen-2017-018465
Keywords Tinnitus, Bi-modal stimulation, neuromodulation
Publisher URL http://bmjopen.bmj.com/content/7/10/e018465
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0





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