Clinical trial NCT01541969: Evaluation of the CR Neuromodulation Treatment for Tinnitus
Official title: Systematic Evaluation of the Acoustic CR ® Neuromodulation Treatment for Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tinnitus
Keywords: Ear
Hearing
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: University College, London
First posted: 2012-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Tinnitus Handicap Questionnaire (THQ)
timeFrame: Baseline (visit 2) and 12 weeks (visit 6)
Secondary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Baseline (visit 2) and 12 weeks (visit 6)
measure: Tinnitus Functional Index (TFI)
timeFrame: Baseline (visit 2) and 12 weeks (visit 6)
measure: World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: Baseline (visit 2) and 12 weeks (visit 6)
measure: Percent Change From Baseline in Normalized Oscillatory Power in the Delta Brainwave Pattern as Measured by Electroencephalography (EEG)
timeFrame: Baseline (visit 2) and 12 weeks (visit 6)
measure: Tinnitus Handicap Questionnaire (THQ)
timeFrame: Baseline (visit 2) and 36 weeks (visit 10)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Ear Institute
city: Nottingham
country: United Kingdom
facility: NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham
Study officials:
affiliation: NIHR Nottingham Hearing Biomedical Research Unit, Unviersity of Nottingham
name: Deborah A Hall, PhD
role: STUDY_DIRECTOR
affiliation: NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham
name: Derek J Hoare, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London, Ear Institute
name: David McAlpine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoare DJ, Edmondson-Jones M, Gander PE, Hall DA. Agreement and reliability of tinnitus loudness matching and pitch likeness rating. PLoS One. 2014 Dec 5;9(12):e114553. doi: 10.1371/journal.pone.0114553. eCollection 2014.
citation: Hoare DJ, Pierzycki RH, Thomas H, McAlpine D, Hall DA. Evaluation of the acoustic coordinated reset (CR(R)) neuromodulation therapy for tinnitus: study protocol for a double-blind randomized placebo-controlled trial. Trials. 2013 Jul 10;14:207. doi: 10.1186/1745-6215-14-207.
citation: Fackrell K, Hall DA, Barry JG, Hoare DJ. Psychometric properties of the Tinnitus Functional Index (TFI): Assessment in a UK research volunteer population. Hear Res. 2016 May;335:220-235. doi: 10.1016/j.heares.2015.09.009. Epub 2015 Sep 28.
citation: Pierzycki RH, McNamara AJ, Hoare DJ, Hall DA. Whole scalp resting state EEG of oscillatory brain activity shows no parametric relationship with psychoacoustic and psychosocial assessment of tinnitus: A repeated measures study. Hear Res. 2016 Jan;331:101-8. doi: 10.1016/j.heares.2015.11.003. Epub 2015 Nov 14.
citation: Fackrell K, Hall DA, Barry JG, Hoare DJ. Response to Letter: Psychometric properties of the Tinnitus Functional Index (TFI): Assessment in a UK research volunteer population. Hear Res. 2016 May;335:237-238. doi: 10.1016/j.heares.2016.03.014. Epub 2016 Mar 30. No abstract available.
citation: Hall DA, Pierzycki RH, Thomas H, Greenberg D, Sereda M, Hoare DJ. Systematic Evaluation of the T30 Neurostimulator Treatment for Tinnitus: A Double-Blind Randomised Placebo-Controlled Trial with Open-Label Extension. Brain Sci. 2022 Feb 26;12(3):317. doi: 10.3390/brainsci12030317.