Evaluation of the CR Neuromodulation Treatment for Tinnitus

NCT01541969 | Completed Phase 2 Results DMC

• 1 other identifier: 11IH006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Tinnitus

Keywords

Ear; Hearing

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Questionnaire (THQ)

  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.

  Baseline (visit 2) and 12 weeks (visit 6)

Secondary Outcomes (5)

• Tinnitus Handicap Inventory (THI)

  Baseline (visit 2) and 12 weeks (visit 6)

• Tinnitus Functional Index (TFI)

  Baseline (visit 2) and 12 weeks (visit 6)

• World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)

  Baseline (visit 2) and 12 weeks (visit 6)

• 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)

• Tinnitus Handicap Questionnaire (THQ)

  Baseline (visit 2) and 36 weeks (visit 10)

Study Arms (2)

CR Neuromodulation

EXPERIMENTAL

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

Tinnitus masking

ACTIVE COMPARATOR

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

Interventions

CR Neuromodulation DEVICE

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.

Also known as: Acoustic Coordinated Reset Neuromodualtion

CR Neuromodulation

Tinnitus masking DEVICE

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.

Also known as: Tinnitus masking only (by CR Neuromodulation device)

Tinnitus masking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• University of Nottingham: collaborator
• University College, London: collaborator

Study Sites (2)

University College London Ear Institute

London, WC1X 8EE, United Kingdom

Location

NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham

Nottingham, NG1 5DU, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 25478690 BACKGROUND

• 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.

  PMID: 23842505 BACKGROUND

• 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.

  PMID: 26415998 BACKGROUND

• 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.

  PMID: 26584760 BACKGROUND

• 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.

  PMID: 27039256 BACKGROUND

• 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.

  PMID: 35326273 DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Clinical Trial Protocol inadequately specified, particularly (i) device fitting, (ii) tolerance for pitch matching shifts and (iii) monitoring research audiologists after training. Specification of placebo algorithm is not evidenced by published data

Results Point of Contact

• Title: Professor Deborah Hall, Professor of Hearing Sciences
• Organization: University of Nottingham

deborah.hall@nottingham.ac.uk

+44 (0) 115 823 2600

Study Officials

• Deborah A Hall, PhD

  NIHR Nottingham Hearing Biomedical Research Unit, Unviersity of Nottingham

  STUDY DIRECTOR

• Derek J Hoare, PhD

  NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham

  PRINCIPAL INVESTIGATOR

• David McAlpine, PhD

  University College London, Ear Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 1, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 22, 2016
• Results First Posted: June 18, 2015

Record last verified: 2015-05

Locations

GB (2)