Evaluation of the CR Neuromodulation Treatment for Tinnitus (RESET2)

This study has been completed.
Sponsor:
Collaborators:
University of Nottingham
University College, London
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01541969
First received: February 24, 2012
Last updated: June 17, 2015
Last verified: May 2015
  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
Device: Tinnitus masking
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

Resource links provided by NLM:


Further study details as provided by Nottingham University Hospitals NHS Trust:

Primary Outcome Measures:
  • Tinnitus Handicap Questionnaire (THQ) [ Time Frame: Baseline (visit 2) and 12 weeks (visit 6) ] [ Designated as safety issue: No ]
    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:
  • Tinnitus Handicap Inventory (THI) [ Time Frame: Baseline (visit 2) and 12 weeks (visit 6) ] [ Designated as safety issue: No ]
    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.

  • Tinnitus Functional Index (TFI) [ Time Frame: Baseline (visit 2) and 12 weeks (visit 6) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (visit 2) and 12 weeks (visit 6) ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Normalized Oscillatory Power in the Delta Brainwave Pattern as Measured by Electroencephalography (EEG) [ Time Frame: Baseline (visit 2) and 12 weeks (visit 6) ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline (visit 2) and 36 weeks (visit 10) ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: August 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CR Neuromodulation
Adaptive NeuroModulation (ANM) T30 CR® Neurostimulator device. Participants receive the intervention according to the manufacturer/funder training given to the study team.
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.

Other Name: Acoustic Coordinated Reset Neuromodualtion
Active Comparator: 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).
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.
Other Name: Tinnitus masking only (by CR Neuromodulation device)

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541969

Locations
United Kingdom
University College London Ear Institute
London, United Kingdom, WC1X 8EE
NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham
Nottingham, United Kingdom, NG1 5DU
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
University of Nottingham
University College, London
Investigators
Study Director: Deborah A Hall, PhD NIHR Nottingham Hearing Biomedical Research Unit, Unviersity of Nottingham
Principal Investigator: Derek J Hoare, PhD NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham
Principal Investigator: David McAlpine, PhD University College London, Ear Institute
  More Information

Additional Information:
Publications:
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
Results First Received: April 18, 2015
Last Updated: June 17, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Nottingham University Hospitals NHS Trust:
Ear
Hearing

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on June 28, 2015