EMDR as a Treatment for Tinnitus

NCT03218046 | Completed

• 1 other identifier: 174629
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Change in tinnitus handicap inventory score

  Tinnitus questionnaire

  6 months

Secondary Outcomes (7)

• Beck Depression Inventory (T0, T1, T2)

  6 months

• Beck Anxiety Inventory(T0, T1, T2)

  6 months

• Posttraumatic Stress Diagnostic Scale (T0, T1, T2)

  6 months

• Pure Tone Audiogram (T0).

  6 months

• Psychoacoustic parameters: (T0, T1, T2) a. Intensity - Tinnitus loudness estimate using a VAS b. Loudness Discomfort Level (LDL) at 250-8000Hz

  6 months

Study Arms (1)

EMDR group

EXPERIMENTAL

This is the treatment arm that will receive EMDR therapy

Behavioral: EMDR

Interventions

EMDR BEHAVIORAL

Eye Movement Desensitisation and Reprocessing

EMDR group

Eligibility Criteria

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

You may qualify if:

• \- 1. 'Subjective Idiopathic Tinnitus', specifically 'Chronic Decompensated Tinnitus' with a THI score of 38 to 100.
• \. Tinnitus for greater than 6 months duration. 3. Aged over 18 4. Willing to commit to a full course of EMDR therapy

Sponsors & Collaborators

• Julie Dawson: lead

Study Sites (1)

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (26)

• Lockwood AH, Salvi RJ, Burkard RF. Tinnitus. N Engl J Med. 2002 Sep 19;347(12):904-10. doi: 10.1056/NEJMra013395. No abstract available.

  PMID: 12239260 BACKGROUND

• Noell CA, Meyerhoff WL. Tinnitus. Diagnosis and treatment of this elusive symptom. Geriatrics. 2003 Feb;58(2):28-34.

  PMID: 12596495 BACKGROUND

• Davis A, El Rafaie A. Epidemiology of tinnitus. In: Tyler RS, (ed). Tinnitus Handbook. San Diego: Singular, 2000; 1-23.

  BACKGROUND

• McFerran DJ, Phillips JS. Tinnitus. J Laryngol Otol. 2007 Mar;121(3):201-8. doi: 10.1017/S0022215106002714. Epub 2006 Sep 25.

  PMID: 16995967 BACKGROUND

• Oren, E. and R. Solomon (2012).

  BACKGROUND

• Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.

  PMID: 12849487 BACKGROUND

• Shapiro F. Efficacy of the eye movement desensitization procedure in the treatment of traumatic memories. J Trauma Stress. 1989;2(2):199-223.

  BACKGROUND

• Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.

  PMID: 17636720 BACKGROUND

• Shapiro F. Eye Movement Desensitization and Reprocessing (EMDR): Basic Principles, Protocols, and Procedures, 2nd Edition. 2001. The Guilford Press.

  BACKGROUND

• Dyck MJ. A proposal for a conditioning model of eye movement desensitization treatment for posttraumatic stress disorder. J Behav Ther Exp Psychiatry. 1993 Sep;24(3):201-10. doi: 10.1016/0005-7916(93)90022-o.

  PMID: 7910613 BACKGROUND

• Kuiken D, Bears M, Miall D, Smith L. Eye Movement Desensitisation Reprocessing Facilitates Attentional Orienting. Imagination, Cognition and Personality. 2002;21:3-20.

  BACKGROUND

• Hassard A. Reverse learning and the physiological basis of eye movement desensitization. Med Hypotheses. 1996 Oct;47(4):277-82. doi: 10.1016/s0306-9877(96)90067-5.

  PMID: 8910876 BACKGROUND

• MacCulloch MJ, Feldman P. Eye movement desensitisation treatment utilises the positive visceral element of the investigatory reflex to inhibit the memories of post-traumatic stress disorder: a theoretical analysis. Br J Psychiatry. 1996 Nov;169(5):571-9. doi: 10.1192/bjp.169.5.571.

  PMID: 8932885 BACKGROUND

• Barrowcliff AL, Gray NS, MacCulloch S, Freeman TC, MacCulloch MJ. Horizontal rhythmical eye movements consistently diminish the arousal provoked by auditory stimuli. Br J Clin Psychol. 2003 Sep;42(Pt 3):289-302. doi: 10.1348/01446650360703393.

  PMID: 14565894 BACKGROUND

• Jastreboff PJ. Phantom auditory perception (tinnitus): mechanisms of generation and perception. Neurosci Res. 1990 Aug;8(4):221-54. doi: 10.1016/0168-0102(90)90031-9.

  PMID: 2175858 BACKGROUND

• National Institute for Clinical Excellence (2005). Post traumatic stress disorder (PTSD): The management of adults and children in primary and secondary care. London: NICE Guidelines. . http://www.oqp.med.va.gov/cpg/PTSD/PTSD_cpg/frameset.htm

  BACKGROUND

• Ursano RJ, Bell C, Eth S, Friedman M, Norwood A, Pfefferbaum B, Pynoos JD, Zatzick DF, Benedek DM, McIntyre JS, Charles SC, Altshuler K, Cook I, Cross CD, Mellman L, Moench LA, Norquist G, Twemlow SW, Woods S, Yager J; Work Group on ASD and PTSD; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Am J Psychiatry. 2004 Nov;161(11 Suppl):3-31. No abstract available.

  PMID: 15617511 BACKGROUND

• van Rood, Y. R. and C. de Roos (2009).

  BACKGROUND

• Farmer A, Rooney R, Cunningham JR. Hypothesized eye movements of neurolinguistic programming: a statistical artifact. Percept Mot Skills. 1985 Dec;61(3 Pt 1):717-8. doi: 10.2466/pms.1985.61.3.717.

  PMID: 4088761 BACKGROUND

• Wertheim EH, Habib C, Cumming G. Test of the neurolinguistic programming hypothesis that eye-movements relate to processing imagery. Percept Mot Skills. 1986 Apr;62(2):523-9. doi: 10.2466/pms.1986.62.2.523.

  PMID: 3503261 BACKGROUND

• Baguley DM, Phillips J, Humphriss RL, Jones S, Axon PR, Moffat DA. The prevalence and onset of gaze modulation of tinnitus and increased sensitivity to noise after translabyrinthine vestibular schwannoma excision. Otol Neurotol. 2006 Feb;27(2):220-4. doi: 10.1097/01.mao.0000172412.87778.28.

  PMID: 16436993 BACKGROUND

• Coad ML, Lockwood A, Salvi R, Burkard R. Characteristics of patients with gaze-evoked tinnitus. Otol Neurotol. 2001 Sep;22(5):650-4. doi: 10.1097/00129492-200109000-00016.

  PMID: 11568674 BACKGROUND

• Biggs ND, Ramsden RT. Gaze-evoked tinnitus following acoustic neuroma resection: a de-afferentation plasticity phenomenon? Clin Otolaryngol Allied Sci. 2002 Oct;27(5):338-43. doi: 10.1046/j.1365-2273.2002.00591.x.

  PMID: 12383293 BACKGROUND

• Lockwood AH, Wack DS, Burkard RF, Coad ML, Reyes SA, Arnold SA, Salvi RJ. The functional anatomy of gaze-evoked tinnitus and sustained lateral gaze. Neurology. 2001 Feb 27;56(4):472-80. doi: 10.1212/wnl.56.4.472.

  PMID: 11222790 BACKGROUND

• Husain FT. Neural network models of tinnitus. Prog Brain Res. 2007;166:125-40. doi: 10.1016/S0079-6123(07)66011-7.

  PMID: 17956777 BACKGROUND

• Moller AR. Pathophysiology of tinnitus. Ann Otol Rhinol Laryngol. 1984 Jan-Feb;93(1 Pt 1):39-44.

  PMID: 6367601 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John Phillips

  Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Services Manager

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: July 14, 2017
• Study Start: July 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: October 2, 2018
• Last Updated: July 29, 2019

Record last verified: 2019-07

Locations

GB (1)