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

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

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, Article e018465. https://doi.org/10.1136/bmjopen-2017-018465

• Journal Article Type: Article
• Acceptance Date: Aug 23, 2017
• Online Publication Date: Oct 25, 2017
• Deposit Date: Aug 24, 2017
• Publicly Available Date: Oct 25, 2017
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 7
• Article Number: e018465
• DOI: https://doi.org/10.1136/bmjopen-2017-018465
• Keywords: Tinnitus, Bi-modal stimulation, neuromodulation
• Public URL: https://nottingham-repository.worktribe.com/output/889197
• Publisher URL: http://bmjopen.bmj.com/content/7/10/e018465