TY - JOUR
T1 - Systematic Evaluation of the T30 Neurostimulator Treatment for Tinnitus
T2 - A Double-Blind Randomised Placebo-Controlled Trial with Open-Label Extension
AU - Hall, Deborah Ann
AU - Pierzycki, Robert Henryk
AU - Thomas, Holly
AU - Greenberg, David
AU - Sereda, Magdalena
AU - Hoare, Derek James
N1 - Funding Information:
Funding: D.A.H. and D.J.H. were awarded a grant from The Tinnitus Clinic (Brook Henderson Group, Reading, UK) to conduct this trial in partnership with the device manufacturer at the time, Adaptive Neuromodulation GmbH (ANM) Köln, Germany). This grant only part-funded the trial-related work because not all contracted payments were made. Staff at the Tinnitus Clinic inputted into the details of the device fitting protocol and provided specialist training to the research audiologists for device fitting and recalibration, but had no role in study design, data collection, data analysis, data interpretation or writing of the report. D.J.H. and M.S. are funded by the National Institute for Health Research (NIHR) Biomedical Research Centre Program. The views expressed are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR, or the Department of Health and Social Care.
Funding Information:
D.A.H. and D.J.H. were awarded a grant from The Tinnitus Clinic (Brook Henderson Group, Reading, UK) to conduct this trial in partnership with the device manufacturer at the time, Adaptive Neuromodulation GmbH (ANM) K?ln, Germany). This grant only part-funded the trial-related work because not all contracted payments were made. Staff at the Tinnitus Clinic inputted into the details of the device fitting protocol and provided specialist training to the research audiologists for device fitting and recalibration, but had no role in study design, data collection, data analysis, data interpretation or writing of the report. D.J.H. and M.S. are funded by the National Institute for Health Research (NIHR) Biomedical Research Centre Program. The views expressed are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR, or the Department of Health and Social Care. Acknowledgments: We thank David McAlpine for his input into the design and for supporting the delivery of the trial at UCL. Project audiology staff at the London site were Cherilee Rutherford, Priya Singh, University College London Ear Institute, Hannah Williams, UCL Hospitals NHS Trust, and Amy Chapman, Royal National Throat Nose and Ear Hospital, London. Sandra Smith (NIHR Nottingham Biomedical Research Centre) contributed to recruitment, screening and participant bookings and conducted the minimisation and randomisation for all 100 recruited participants. Collection of assessment and outcomes data was done by Bridgitte Hartley (London centre), while Sandra Smith monitored integrity of randomisation, data collection and data entry. D.A.H. contributed to this work while employed by the University of Nottingham, but critically reviewed and revised the manuscript while employed at Heriot-Watt University Malaysia.
Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2022/3
Y1 - 2022/3
N2 - Tinnitus is often triggered by cochlear damage and has been linked with aberrant patterns of neuronal activity. Acoustic Coordinated Reset (CR®) Neuromodulation is a sound therapy hypothesised to reduce tinnitus symptoms by desynchronising pathological brain activity using a portable acoustic device (the T30 neurostimulator). We report results of a pivotal trial to test the efficacy of this intervention. This two-centre, double-blind randomised controlled trial with long-term open-label extension, was undertaken between February 2012 and February 2014 in the UK. Participants were 100 adults with tinnitus as a primary complaint, recruited through hearing clinics and media advertisements. Intervention was the device programmed either with the proprietary sound sequence or placebo algorithm, fit by one of five trained audiologists. Minimisation software provided group allocation (1:1 randomisation), with groups matched for age, gender, hearing loss and tinnitus severity. Allocation was masked from participants and assessors during the trial. The primary measure of efficacy was change in tinnitus symptom severity between groups, measured using the Tinnitus Handicap Questionnaire at 12 weeks. Secondary outcomes were other measures of tinnitus symptom severity, health-related quality of life, and perceptual characteristics (pitch, loudness, bandwidth) at 12 weeks, and Tinnitus Handicap Questionnaire at 36 weeks (open-label extension). A statistician blinded to the allocation conducted an intention-to-treat analysis that employed linear regressions on minimisation variables, trial centre and intervention group, with multiple imputations for missing data. The study was registered on clinicaltrials.gov (NCT01541969). We screened 391 individuals and assigned interventions to 100 eligible participants. The primary outcome was not statistically significant between groups (mean group = −0.45, 95% CI −5.25 to 4.35; p = 0.85), nor were any of the secondary outcomes. Four adverse events occurred during the trial. Analysis of tinnitus symptom severity data collected across the 24-week open-label extension showed no statistically significant within-group changes after 12, 24, or 36 weeks treatment with the proprietary sound sequence. While individual participants may benefit from sound therapy, Acoustic CR® Neuromodulation did not lead to group-mean reductions on tinnitus symptom severity or other measures compared to placebo, or over time.
AB - Tinnitus is often triggered by cochlear damage and has been linked with aberrant patterns of neuronal activity. Acoustic Coordinated Reset (CR®) Neuromodulation is a sound therapy hypothesised to reduce tinnitus symptoms by desynchronising pathological brain activity using a portable acoustic device (the T30 neurostimulator). We report results of a pivotal trial to test the efficacy of this intervention. This two-centre, double-blind randomised controlled trial with long-term open-label extension, was undertaken between February 2012 and February 2014 in the UK. Participants were 100 adults with tinnitus as a primary complaint, recruited through hearing clinics and media advertisements. Intervention was the device programmed either with the proprietary sound sequence or placebo algorithm, fit by one of five trained audiologists. Minimisation software provided group allocation (1:1 randomisation), with groups matched for age, gender, hearing loss and tinnitus severity. Allocation was masked from participants and assessors during the trial. The primary measure of efficacy was change in tinnitus symptom severity between groups, measured using the Tinnitus Handicap Questionnaire at 12 weeks. Secondary outcomes were other measures of tinnitus symptom severity, health-related quality of life, and perceptual characteristics (pitch, loudness, bandwidth) at 12 weeks, and Tinnitus Handicap Questionnaire at 36 weeks (open-label extension). A statistician blinded to the allocation conducted an intention-to-treat analysis that employed linear regressions on minimisation variables, trial centre and intervention group, with multiple imputations for missing data. The study was registered on clinicaltrials.gov (NCT01541969). We screened 391 individuals and assigned interventions to 100 eligible participants. The primary outcome was not statistically significant between groups (mean group = −0.45, 95% CI −5.25 to 4.35; p = 0.85), nor were any of the secondary outcomes. Four adverse events occurred during the trial. Analysis of tinnitus symptom severity data collected across the 24-week open-label extension showed no statistically significant within-group changes after 12, 24, or 36 weeks treatment with the proprietary sound sequence. While individual participants may benefit from sound therapy, Acoustic CR® Neuromodulation did not lead to group-mean reductions on tinnitus symptom severity or other measures compared to placebo, or over time.
KW - Acoustic CR neuromodulation
KW - Neural synchrony
KW - Neuromodulation
KW - Quality of life
KW - Sound therapy
KW - Tinnitus disorder
UR - http://www.scopus.com/inward/record.url?scp=85125742230&partnerID=8YFLogxK
U2 - 10.3390/brainsci12030317
DO - 10.3390/brainsci12030317
M3 - Article
C2 - 35326273
AN - SCOPUS:85125742230
SN - 2076-3425
VL - 12
JO - Brain Sciences
JF - Brain Sciences
IS - 3
M1 - 317
ER -