Evaluation of the CR Neuromodulation Treatment for Tinnitus

Phase 2

Completed

Conditions: Tinnitus

Interventions: Device: CR Neuromodulation
Device: Tinnitus masking

Registration Number: NCT01541969

Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief 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.

Detailed Description: Tinnitus affects a large number of people in the UK population but is a poorly understood disorder with no form of treatment that benefits everyone. One theory about tinnitus is that it is caused by altered patterns of synchronous nerve firing in the brains hearing centres. It is believed that conditions such as hearing loss lead to changes in how areas of the brain responsible for hearing are 'wired up' causing large areas of the brain to fire at the same time; this is believed to be a mechanism responsible for the sensation of tinnitus. Research suggests that this type of synchronous activity may be interrupted by presenting very specific sequences of sounds to the ears over several months. If sound stimulation can be used to break up patterns of synchronous activity in the hearing brain, then it is argued that it should also be effective in treating tinnitus. The German company ANM have patented a very specific algorithm of sound simulation that is delivered via headphones from a pocket-sized device. This treatment is currently being marketed by the private healthcare sector in Germany and very recently in the UK. The purpose of this study is to independently test the effects of this new therapy on tinnitus severity and related brain activity. We will gather information using questionnaires and listening tests, and make recording of electrical brain activity using electroencephalography (EEG).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

Pure tone average <60 dB HL in the ear where tinnitus is perceived
Must be able to hear all stimulation tones presented by the device
Chronic subjective tinnitus for more than 3 months
Dominant tinnitus frequency measured between 0.2 and 10 kHz
At least mild tinnitus score on the Tinnitus Handicap Inventory
Willing to wear the device for 4-6 hours daily during the trial
Sufficient command of English language to read, understand and complete the questionnaires
Able and willing to give informed consent

Exclusion Criteria

Objective tinnitus, Meniere's disease, craniomandibular induced Tinnitus
Pulsatile tinnitus
Intermittent tinnitus
Severe anxiety
Severe depression
Catastrophic tinnitus
Hearing-aids wearers for less than 9 months
Hearing-aid wearers with audiological adjustments within last 3 months
Absolute thresholds > 70 dB on individual frequencies up to 8 kHz (unable to sufficiently hear the stimulus)
Taking part in another trial during the last 30 days before study start
The individually tailored training stimulus is uncomfortable or not acceptable to the participant

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CR Neuromodulation	CR Neuromodulation	Adaptive NeuroModulation (ANM) T30 CR® Neurostimulator device. Participants receive the intervention according to the manufacturer/funder training given to the study team.
Tinnitus masking	Tinnitus masking	Participants will receive the same Adaptive NeuroModulation (ANM) T30 CR® Neurostimulator device, but it will NOT be programmed according to the therapeutic algorithm (0-12 weeks).

Primary Outcome Measures

Name	Time	Method
Tinnitus Handicap Questionnaire (THQ)	Baseline (visit 2) and 12 weeks (visit 6)	Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.

Secondary Outcome Measures

Name	Time	Method
Tinnitus Functional Index (TFI)	Baseline (visit 2) and 12 weeks (visit 6)	Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.
World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)	Baseline (visit 2) and 12 weeks (visit 6)	The WHOQOL-BREF is a 26-item, multi-attribute questionnaire measure of health related quality of life. Outcome was measured as a change on Question 1: 'How would you rate your quality of life (over the past 4 weeks)?' There are 5 response options (Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction in self-perceived quality of life.
Tinnitus Handicap Inventory (THI)	Baseline (visit 2) and 12 weeks (visit 6)	Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.
Percent Change From Baseline in Normalized Oscillatory Power in the Delta Brainwave Pattern as Measured by Electroencephalography (EEG)	Baseline (visit 2) and 12 weeks (visit 6)	Non-invasive recording to measure rhythmic patterns of spontaneous brain activity at rest. An a priori hypothesis targeted normalized delta rhythm. Band powers were calculated as percent change in delta brainwave pattern relative to change in total (1-90 Hz) EEG band. Comparison made between 'visit 2' and 'visit 6'. We used a Neuroscan system (SynAmps2 model 8050, Compumedics Neuroscan, Charlotte, NC, USA) and custom cap with 66 equidistant scalp electrodes (Easycap, GmbH, Germany). A central frontal electrode was used as ground and a nose-tip electrode as reference. Electrode impedances were maintained at 5 kΩ prior to recordings. Recording was done with an offline filter of 0.5 to 200 Hz pass-band and 1 kHz sampling rate. Recording was over a continuous 10-minute period. Participants were seated in a quiet, darkened soundproof booth and were instructed to relax, keep eyes open and fix gaze on a marker point.
Tinnitus Handicap Questionnaire (THQ)	Baseline (visit 2) and 36 weeks (visit 10)	Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 10' and so a positive change score indicates a reduction of tinnitus symptoms.

Trial Locations

Locations (2): NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham
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Nottingham, United Kingdom
University College London Ear Institute
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London, United Kingdom