Evaluation of the CR Neuromodulation Treatment for Tinnitus

Summary

The purpose of this study is to determine whether a new device delivering a sound-based intervention (termed acoustic coordinated reset neuromodulation) has significant clinical benefit for people with intrusive tinnitus. It is hypothesised that the particular pattern of sound stimulation delivered by the device acts to break up patterns of synchronous nerve firing in the brain that may be responsible for the sensation of tinnitus. We will also measure brain activity in a subset of participants to determine if the intervention results in changes in brainwave activity.

Conditions

• Tinnitus

Interventions

DEVICE

CR Neuromodulation

Ear level device which delivers patterned sound stimulation. The experimental arm will use the device fitted according to audiologist training given by the manufacturer/funder. An individually specified sound stimulation algorithm is hypothesised to interrupt tinnitus generating activity in the brain. For the first 12 weeks participants will be asked to wear the device every day for 6 hours, and in blocks of time not less than 1 hour. After 12 weeks participants will be unblinded and continue with the same experimental intervention. In weeks 13-36 participants will be asked to wear the device every day for 4 hours, in continuous blocks of at least 1 hour.

DEVICE

Tinnitus masking

The active comparator uses the same ear level device and also delivers patterned sound but the stimulus will be determined according to an algorithm predicted not to break up tinnitus generating activity in the brain. It may have a masking effect. For the first 12 weeks participants will be asked to wear the device every day for 6 hours, and in blocks of time not less than 1 hour. After 12 weeks, the participants will be unblinded and the device algorithm will be reprogrammed in the same way as the experimental intervention. In weeks 13-24 participants will be asked to wear the device for 6 hours per day, in continuous blocks of at least 1 hour. In weeks 25-36 they will be asked to continue using the device every day for 4 hours, in continuous blocks of at least 1 hour.

Sponsors & Collaborators

• University of Nottingham

  collaborator OTHER

• University College, London

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Deborah A Hall, PhD · NIHR Nottingham Hearing Biomedical Research Unit, Unviersity of Nottingham

• Derek J Hoare, PhD · NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham

• David McAlpine, PhD · University College London, Ear Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2014-02-28

Completion

2014-02-28

Countries

• United Kingdom

Study Locations