Evaluation of the CR Neuromodulation Treatment for Tinnitus (RESET2)

NHS Trust

Status and phase: Completed; Phase 3; Phase 2

Conditions: Tinnitus

Treatments: Device: Tinnitus masking; Device: CR Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01541969

11IH006

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

CR Neuromodulation

Experimental group

Description:

Adaptive NeuroModulation (ANM) T30 CR® Neurostimulator device. Participants receive the intervention according to the manufacturer/funder training given to the study team.

Treatment:

Device: CR Neuromodulation

Tinnitus masking

Active Comparator group

Description:

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).

Treatment:

Device: Tinnitus masking