EMDR as a Treatment for Tinnitus (EMDR)

July 25, 2019 updated by: Julie Dawson

Eye Movement Desensitisation and Reprocessing (EMDR) as a Treatment for Tinnitus: A Feasibility Study

Tinnitus may be considered as a form of phantom auditory sensation and as such parallels may be drawn with other forms of phantom sensation, such as the sensation of pain in an amputated limb (phantom limb pain). There has been recent interest in the use of eye movement therapies to treat patients with phantom sensations such as these. The role of eye movements in the propagation and maintenance of tinnitus has also been well established. The main aim of this study is to evaluate the effectiveness of an established form of eye movement therapy called Eye Movement Desensitisation and Reprocessing (EMDR). This research is important as EMDR has produced encouraging results for other forms of phantom sensation and current models of tinnitus fit well with the proposed mode of action of EMDR. Tinnitus is very prevalent in our population and is often associated with significant discomfort; however, there is a severe lack of effective treatments based on well designed clinical trials. The investigator wishes to assess the usefulness of EMDR against the current treatment that is available in many institutions including the Investigator's own. The Investigator intends to recruit 15-30 patients initially to run a pilot study, before embarking on a larger scale study. The Investigator hopes that this pilot study will run over the course of a year. If this study demonstrates a significant improvement in tinnitus in patient undergoing EMDR, this will be an important step forward not only for treating patients with this disorder, but also for understanding the pathways that initiate, propagate and maintain tinnitus perception.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tinnitus is a common, yet poorly understood condition. In the UK, a large study using data from more than 500,000 people has found a prevalence of tinnitus of 16.2% (defined as any noise in the ear/s lasting longer than five minutes) and a prevalence of bothersome tinnitus as 3.8% (those who were moderately or severely bothered by their tinnitus on a four point Likert scale). Other international studies have also found a high prevalence of 30% with a total of 6% of the study population reporting incapacitating symptoms from tinnitus. Despite the high worldwide prevalence of tinnitus and the large number of proposed therapies available, there is a distinct paucity of well controlled trials in the literature to support an effective treatment.

Tinnitus may be considered as a form of phantom auditory perception and as such parallels may be drawn with other forms of phantom sensation, there has been recent interest in the use of eye movement therapies to treat patients with phantom sensations such as phantom limb pain. Both studies of those with tinnitus and phantom limb pain have suggested a psychological component such as certain premorbid personality traits may also contribute or predispose to these conditions and consequently be helped by psychological therapies.

Eye Movement Desensitisation and Reprocessing (EMDR) was first described by Shapiro in 1989 and requires the subject to perform relatively rapid movements of the eyes. Its application has been particularly documented in the context of post-traumatic stress disorder (PTSD). EMDR has been described as an integrative psychotherapy, due to its assimilation of various elements from diverse psychotherapies. A number of models have been proposed to account for the role of eye movements in EMDR, these include Shapiro's Adaptive Information Processing Model, Dyck's conditioning model, attentional processing accounts and theories of reverse learning . A recurrent mechanism in a number of these accounts is that of the orientating reflex. MacCollock and Feldman argue that lateral eye-movements trigger an investigatory component of this reflex to assess safety with regard to potential external threats . Where threats are positively identified, a flight or flight response is initiated; in situations where no danger is identified a functional reduction in arousal takes place. Support for this reassurance response in non-clinical patients has been demonstrated using auditory stimuli. Overlap between these concepts and theories related to the perception of tinnitus bode well, especially when one considers the neurophysiological model proposed by Jastreboff.

Since its introduction in 1989, numerous controlled studies have been conducted to evaluate EMDR's utility as a treatment for various forms of trauma-related complaints, including PTSD. The positive results have established EMDR as an effective trauma treatment and have prompted numerous professional organisations to recognise its efficacy, beginning with the American Psychological Association's (APA) Division 12 Task Force on Psychological Interventions in 1998. Since then, the NHS the International Society for Traumatic Stress Studies , the Israeli National Council for Mental Health , and the Northern Ireland Department of Health have also supported EMDR. Most recently, the US Departments of Defence and Veterans Affairs stated that EMDR was an effective treatment of trauma, as did the American Psychiatric Association . It has also been found to be helpful in medically unexplained symptoms and somatoform disorders.

Other forms of eye movement therapy have been popularised, such as eye movement integration therapy (EMI) in which eye movements in specific directions provide access strategies to different sensory domains. EMI was originally developed from research in the field of neuro-linguistic programming (NLP) and has also been widely used in the treatment of PTSD. EMI uses slower eye movements that are thought to access internal dialogue or emotional and feeling areas of the brain. Initially the concept of specifically accessing domains associated with auditory-based cue was appealing as a therapy for an auditory based pathology, however, despite initial enthusiasm for EMI the specificity of these associations has been disputed.

The role of eye movements in the propagation and maintenance of tinnitus has been well established, although the exact neurophysiological mechanisms of how eye movements integrate within the central auditory areas is not fully understood, however functional imaging has suggested a number of neuroanatomical sites. Cognitive science has provided neural networks that model tinnitus, these neural network models were inspired by theoretical models that described possible neural mechanisms mediating tinnitus. The majority of these models rely on the lateral-inhibition network (LIN) to simulate tinnitus and focus on the role of central auditory processing regions as possible anatomical locations of the physiological abnormalities that cause tinnitus. Recent work has identified a number of regions responsible for the generation and modulation of tinnitus including limbic, somatosensory and motor areas.

There has been some encouraging work described in the German literature regarding the effectiveness of EMDR for the treatment of tinnitus. The application of eye movement therapies to treat patients with tinnitus would seem logical considering the context our current understanding of tinnitus; the next step would be to test this theory in the setting of a formal randomised controlled clinical study.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- 1. 'Subjective Idiopathic Tinnitus', specifically 'Chronic Decompensated Tinnitus' with a THI score of 38 to 100.

2. Tinnitus for greater than 6 months duration. 3. Aged over 18 4. Willing to commit to a full course of EMDR therapy

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMDR group
This is the treatment arm that will receive EMDR therapy
Behavioral: EMDR
Eye Movement Desensitisation and Reprocessing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tinnitus handicap inventory score
Time Frame: 6 months
Tinnitus questionnaire
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (T0, T1, T2)
Time Frame: 6 months
Depression questionnaire
6 months
Beck Anxiety Inventory(T0, T1, T2)
Time Frame: 6 months
Anxiety questionnaire
6 months
Posttraumatic Stress Diagnostic Scale (T0, T1, T2)
Time Frame: 6 months
Post traumatic stress questionnaire
6 months
Pure Tone Audiogram (T0).
Time Frame: 6 months
Hearing test
6 months
Psychoacoustic parameters: (T0, T1, T2) a. Intensity - Tinnitus loudness estimate using a VAS b. Loudness Discomfort Level (LDL) at 250-8000Hz
Time Frame: 6 months
Quasi objective measure of tinnitus
6 months
Five factor personality inventory (T0)
Time Frame: 6 months
Personality questionnaire
6 months
Free text evaluation of treatment and trial protocol (T2)
Time Frame: 6 months
Open appraisal of study
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julie Dawson

Investigators

  • Principal Investigator: John Phillips, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

October 2, 2018

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 174629

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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