Evaluation of the CR Neuromodulation Treatment for Tinnitus (RESET2)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tinnitus |
Device: CR Neuromodulation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Systematic Evaluation of the Acoustic CR ® Neuromodulation Treatment for Tinnitus |
- Change in Tinnitus Handicap Questionnaire score [ Time Frame: Screening, baseline, 4, 8, 12, 24, and 36 weeks ] [ Designated as safety issue: No ]Validated and sensitive questionnaire measure of tinnitus intrusiveness
- Change in Tinnitus Handicap Inventory score category [ Time Frame: Screening, baseline, 12, 24, and 36 weeks ] [ Designated as safety issue: No ]Validated questionnaire measure of tinnitus severity
- Change in Tinnitus Functional Index score [ Time Frame: Screening, baseline, 4, 8, 12, 24, and 36 weeks ] [ Designated as safety issue: No ]Recently developed and validated questionnaire measure of tinnitus severity that is also sensitive to change
- Change in World Health Organization Quality of Life questionnaire (WHOQOL) [ Time Frame: Screening, baseline, 12 weeks ] [ Designated as safety issue: No ]Validate questionnaire measure of health related quality of life.
- Change in brainwave patterns as measured by electroencephalography (EEG) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Standard EEG technique to measure rhythmic patterns of brain activity at rest. Will only be measured during the randomized phase of the trial (12 week placebo versus control).
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CR Neuromodulation
Participants will receive the intervention according to the proprietary algorithm.
|
Device: CR Neuromodulation
Ear level device which delivers patterned sound stimulation. Participants will be asked to wear the device for 4-6 hours per day over a 9 month period. The experimental arm will receive the intervention according to the proprietary setting which is hypothesised to interrupt tinnitus generating activity in the brain. The active comparator will receive the same device but the sound stimulation will be determined according to a programme predicted not to break up tinnitus generating activity in the brain. The device may have a tinnitus masking effect in the active comparator group. After the first 12 weeks all participants will receive the experimental intervention.
Other Name: acoustic coordinated reset neuromodualtion
|
|
Active Comparator: Tinnitus masking
Participants will receive the same device but it will not be calibrated according to the proprietary algorithm.
|
Device: CR Neuromodulation
Ear level device which delivers patterned sound stimulation. Participants will be asked to wear the device for 4-6 hours per day over a 9 month period. The experimental arm will receive the intervention according to the proprietary setting which is hypothesised to interrupt tinnitus generating activity in the brain. The active comparator will receive the same device but the sound stimulation will be determined according to a programme predicted not to break up tinnitus generating activity in the brain. The device may have a tinnitus masking effect in the active comparator group. After the first 12 weeks all participants will receive the experimental intervention.
Other Name: acoustic coordinated reset neuromodualtion
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| University College London Ear Institute | |
| London, United Kingdom, WC1X 8EE | |
| NIHR National Biomedical research Unit in Hearing, University of Nottingham | |
| Nottingham, United Kingdom, NG1 5DU | |
| Study Director: | Deborah A Hall, PhD | NIHR National Biomedical Research Unit in Hearing, Unviersity of Nottingham |
| Principal Investigator: | Derek J Hoare, PhD | NIHR National Biomedical Research Unit in Hearing, University of Nottingham |
| Principal Investigator: | David McAlpine, PhD | University Colege London Ear Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Nottingham University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01541969 History of Changes |
| Other Study ID Numbers: | 11IH006 |
| Study First Received: | February 24, 2012 |
| Last Updated: | June 7, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Nottingham University Hospitals NHS Trust:
|
Ear Hearing |
Additional relevant MeSH terms:
|
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013