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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.
BMJ Open. 2017 Oct 25; 7(10):e018465.BO

Abstract

INTRODUCTION

Tinnitus is the perception of sound in the absence of a corresponding external acoustic stimulus. Bimodal neuromodulation is emerging as a promising treatment for this condition. The main objectives of this study are to investigate the relevance of interstimulus timing and the choices of acoustic and tongue stimuli for a proprietary bimodal (auditory and somatosensory) neuromodulation device, as well as 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 bimodal 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 stepwise stratification according to four binary categories: tinnitus tonality, sound level tolerance (using loudness discomfort level of <60 dB SL as an indicator for hyperacusis), hearing thresholds and presence of a noise-induced audiometric profile. The main indicators of relative clinical efficacy for the three different parameter sets are two patient-reported outcomes measures, the Tinnitus Handicap Inventory and the Tinnitus Functional Index, after 12 weeks of intervention. Clinical efficacy will be further explored in a series of patient subtypes, split by the stratification variables and by presence of a somatic tinnitus. Evidence for sustained effects on the psychological and functional impact of tinnitus will be followed up for 12 months. Safety data will be collected and reported. A number of feasibility measures to inform future trial design include: reasons for exclusion, completeness of data collection, attrition rates, patient's adherence to the device usage as per manufacturer's instructions and evaluation of alternative methods for estimating tinnitus impact and tinnitus loudness.

ETHICS AND DISSEMINATION

This study protocol is approved by the Tallaght Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland, and by the Ethics Committee of the University Clinic Regensburg, Germany. Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences.

TRIAL REGISTRATION NUMBER

The trial is registered on ClinicalTrials.gov (NCT02669069) Pre-results.

Authors+Show Affiliations

Neuromod Devices Limited, Dublin, Ireland.Neuromod Devices Limited, Dublin, Ireland.Neuromod Devices Limited, Dublin, Ireland.National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham, UK. Otology and Hearing Group, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.Lab for Clinical and Integrative Neuroscience, School of Behavioral and Brain Sciences, The University of Texas at Dallas, Richardson, Texas, USA.Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany. Interdisciplinary Tinnitus Center of the University of Regensburg, Regensburg, Germany.Neuromod Devices Limited, Dublin, Ireland. ENT, Tallaght Hospital, Dublin, Ireland. ENT, St. James's Hospital, Dublin, Ireland. Department of Medicine, Trinity College, Dublin, Ireland.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29074518

Citation

D'Arcy, Shona, et al. "Bi-modal Stimulation in the Treatment of Tinnitus: a Study Protocol for an Exploratory Trial to Optimise Stimulation Parameters and Patient Subtyping." BMJ Open, vol. 7, no. 10, 2017, pp. e018465.
D'Arcy S, Hamilton C, Hughes S, et al. Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping. BMJ Open. 2017;7(10):e018465.
D'Arcy, S., Hamilton, C., Hughes, S., Hall, D. A., Vanneste, S., Langguth, B., & Conlon, B. (2017). 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(10), e018465. https://doi.org/10.1136/bmjopen-2017-018465
D'Arcy S, et al. Bi-modal Stimulation in the Treatment of Tinnitus: a Study Protocol for an Exploratory Trial to Optimise Stimulation Parameters and Patient Subtyping. BMJ Open. 2017 Oct 25;7(10):e018465. PubMed PMID: 29074518.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping. AU - D'Arcy,Shona, AU - Hamilton,Caroline, AU - Hughes,Stephen, AU - Hall,Deborah A, AU - Vanneste,Sven, AU - Langguth,Berthold, AU - Conlon,Brendan, Y1 - 2017/10/25/ PY - 2017/10/28/entrez PY - 2017/10/28/pubmed PY - 2018/6/22/medline KW - bi-modal stimulation KW - neuromodulation KW - tinnitus SP - e018465 EP - e018465 JF - BMJ open JO - BMJ Open VL - 7 IS - 10 N2 - INTRODUCTION: Tinnitus is the perception of sound in the absence of a corresponding external acoustic stimulus. Bimodal neuromodulation is emerging as a promising treatment for this condition. The main objectives of this study are to investigate the relevance of interstimulus timing and the choices of acoustic and tongue stimuli for a proprietary bimodal (auditory and somatosensory) neuromodulation device, as well as 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 bimodal 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 stepwise stratification according to four binary categories: tinnitus tonality, sound level tolerance (using loudness discomfort level of <60 dB SL as an indicator for hyperacusis), hearing thresholds and presence of a noise-induced audiometric profile. The main indicators of relative clinical efficacy for the three different parameter sets are two patient-reported outcomes measures, the Tinnitus Handicap Inventory and the Tinnitus Functional Index, after 12 weeks of intervention. Clinical efficacy will be further explored in a series of patient subtypes, split by the stratification variables and by presence of a somatic tinnitus. Evidence for sustained effects on the psychological and functional impact of tinnitus will be followed up for 12 months. Safety data will be collected and reported. A number of feasibility measures to inform future trial design include: reasons for exclusion, completeness of data collection, attrition rates, patient's adherence to the device usage as per manufacturer's instructions and evaluation of alternative methods for estimating tinnitus impact and tinnitus loudness. ETHICS AND DISSEMINATION: This study protocol is approved by the Tallaght Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland, and by the Ethics Committee of the University Clinic Regensburg, Germany. Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences. TRIAL REGISTRATION NUMBER: The trial is registered on ClinicalTrials.gov (NCT02669069) Pre-results. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/29074518/Bi_modal_stimulation_in_the_treatment_of_tinnitus:_a_study_protocol_for_an_exploratory_trial_to_optimise_stimulation_parameters_and_patient_subtyping_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&amp;pmid=29074518 DB - PRIME DP - Unbound Medicine ER -