Neurofeedback for Tinnitus - Does Frequency Specificity Matter?

NCT03550430 | Completed

• 1 other identifier: Neurofeedback for tinnitus
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy of an alpha/delta ratio (ADR) neurofeedback training protocol on tinnitus distress. 1/3 of the participants in the study will undergo ADR neurofeedback training, 1/3 an active comparator, beta/theta ratio (BTR) neurofeedback training, whilst the final 1/3 of participants will fill in daily diaries of tinnitus complaints and symptoms for two weeks.

Conditions

Tinnitus; Subjective Tinnitus; Chronic Tinnitus

Keywords

tinnitus distress; tinnitus intrusiveness; synchronization by loss of inhibition model (SLIM); neurofeedback; alpha/delta neurofeedback; beta/theta neurofeedback; electroencephalography (EEG); tinnitus intensity; tinnitus loudness

Outcome Measures

Primary Outcomes (2)

• Tinnitus Handicap Inventory (THI; Newman, Sandridge, & Jacobson, 1998)

  Self-report measure of tinnitus handicap assessed pre-intervention, mid-treatment (five sessions), post-intervention and at three month follow-up. The Tinnitus Handicap Inventory is a 25 item questionnaire. Each item is scored 0 - 4 (0 = No, 2 = Sometimes, 4 = Yes), yielding a total between 0 (no handicap) - 100 (catastrophic impact).

  16 weeks

• Tinnitus Magnitude Index (TMI; Schmidt, Kerns, Griest, Theodoroff, Pietrzak, & Henry, 2014).

  TMI measures tinnitus intensity, three-item scale assessing self-reported severity, loudness and awareness. \- Visual analogue scale ranges from 0-10 or 0-100, respectively: item 1 (loudness): Range 0 (not at all strong or loud) to 10 (extremely strong or loud) item 2 (awareness): 0 to 100 in increments of 10, with verbal anchors of 0="never aware" and 100="always aware" item 3 (severity): 0-100 with verbal anchors of 0="no tinnitus present" to 100="the worst tinnitus you can imagine" * for all items higher values indicate higher tinnitus magnitude * values of the three items can be summed up to a total score. For standardisation, items are converted from 0-100 to 0-10.

  16 weeks

Secondary Outcomes (7)

• Tinnitus Functional Index (TFI; Brüggemann, Szczepek, Kleinjung, Ojo, & Mazurek, 2017)

  16 weeks

• Brief Illness Perception Questionnaire (B-IPQ; Broadbent, Petrie, Main, & Weinman, 2006)

  4 weeks

• Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001)

  4 weeks

• Credibility and Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)

  4 weeks

• Sustained Attention Response Task (SART; Robertson, Manly, Andrade, Baddeley, & Yiend, 1997)

  16 weeks

Other Outcomes (1)

• Satisfaction with treatment

  3 months

Study Arms (3)

ADR neurofeedback

EXPERIMENTAL

Ten ADR neurofeedback training sessions. The first five sessions comprise four training blocks. The latter five sessions consists of five training blocks each. All training blocks are seven minutes in duration. Participants take between two to three sessions each week.

Behavioral: alpha/delta neurofeedback

BTR neurofeedback

ACTIVE COMPARATOR

Ten BTR neurofeedback training sessions. The first five sessions comprise four training blocks. The latter five sessions each consists of five training blocks. All training blocks are seven minutes in duration. Participants take between two to three sessions each week.

Behavioral: beta/theta neurofeedback

Diary Control Group

ACTIVE COMPARATOR

Daily diary completion for two weeks in the period between baseline and end-point assessments (total period baseline to end-point = four weeks).

Other: Diary completion

Interventions

alpha/delta neurofeedback BEHAVIORAL

neurofeedback training protocol seeking to decrease the alpha/delta ratio, by simultaneous rewarding alpha and inhibiting delta activity.

ADR neurofeedback

beta/theta neurofeedback BEHAVIORAL

neurofeedback training protocol seeking to decrease the beta/theta ratio, by simultaneous rewarding beta and inhibiting theta activity.

BTR neurofeedback

Diary completion OTHER

completion of diary relating to participants' experience of tinnitus intensity, interference, coping, harm and disability. Rated three times daily on numerical scale (0 - 10) for two weeks.

Diary Control Group

Eligibility Criteria

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

You may qualify if:

• Chronic subjective tinnitus, i.e. tinnitus with a duration \> 6 months
• At least mild tinnitus distress, corresponding to a score of ≥ 18 on the Tinnitus Handicap Inventory

You may not qualify if:

• Moderately severe or severe depression
• Objective tinnitus, where causes are classified according to whether they are vascular or non-vascular in origin
• Current use of psychotropic drugs for a mental health condition
• Bipolar disorder, Attention Deficit Hyperactivity Disorder (ADHD), Psychosis
• Substance abuse
• Current psychotherapeutic treatment for tinnitus, previous biofeedback- or neurofeedback treatment
• A history of seizures, strokes and/or brain hemorrhages

Sponsors & Collaborators

• Philipps University Marburg: lead
• Eriksholm Research Centre: collaborator
• Linkoeping University: collaborator
• University Hospital of Gießen and Marburg: collaborator

Study Sites (1)

Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

Marburg, Hesse, 35037, Germany

Location

Related Publications (14)

• Balkenhol T, Wallhausser-Franke E, Delb W. Psychoacoustic tinnitus loudness and tinnitus-related distress show different associations with oscillatory brain activity. PLoS One. 2013;8(1):e53180. doi: 10.1371/journal.pone.0053180. Epub 2013 Jan 10.

  PMID: 23326394 BACKGROUND

• Dohrmann K, Weisz N, Schlee W, Hartmann T, Elbert T. Neurofeedback for treating tinnitus. Prog Brain Res. 2007;166:473-85. doi: 10.1016/S0079-6123(07)66046-4.

  PMID: 17956812 BACKGROUND

• Weisz N, Dohrmann K, Elbert T. The relevance of spontaneous activity for the coding of the tinnitus sensation. Prog Brain Res. 2007;166:61-70. doi: 10.1016/S0079-6123(07)66006-3.

  PMID: 17956772 BACKGROUND

• Weisz N, Hartmann T, Muller N, Lorenz I, Obleser J. Alpha rhythms in audition: cognitive and clinical perspectives. Front Psychol. 2011 Apr 26;2:73. doi: 10.3389/fpsyg.2011.00073. eCollection 2011.

  PMID: 21687444 BACKGROUND

• Newman CW, Sandridge SA, Jacobson GP. Psychometric adequacy of the Tinnitus Handicap Inventory (THI) for evaluating treatment outcome. J Am Acad Audiol. 1998 Apr;9(2):153-60.

  PMID: 9564679 BACKGROUND

• Schmidt CJ, Kerns RD, Griest S, Theodoroff SM, Pietrzak RH, Henry JA. Toward development of a tinnitus magnitude index. Ear Hear. 2014 Jul-Aug;35(4):476-84. doi: 10.1097/AUD.0000000000000017.

  PMID: 24603542 BACKGROUND

• Bruggemann P, Szczepek AJ, Kleinjung T, Ojo M, Mazurek B. [Validation of the German Version of Tinnitus Functional Index (TFI)]. Laryngorhinootologie. 2017 Sep;96(9):615-619. doi: 10.1055/s-0042-122342. Epub 2017 May 12. German.

  PMID: 28499301 BACKGROUND

• Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.

  PMID: 16731240 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

• Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.

  PMID: 11970796 BACKGROUND

• Robertson IH, Manly T, Andrade J, Baddeley BT, Yiend J. 'Oops!': performance correlates of everyday attentional failures in traumatic brain injured and normal subjects. Neuropsychologia. 1997 Jun;35(6):747-58. doi: 10.1016/s0028-3932(97)00015-8.

  PMID: 9204482 BACKGROUND

• Gräfe, K., Zipfel, S., Herzog, W., & Löwe, B. (2004). Screening psychischer Störungen mit dem "Gesundheitsfragebogen für Patienten (PHQ-D)". Diagnostica, 50(4), 171-181.

  BACKGROUND

• Jensen M, Huttenrauch E, Schmidt J, Andersson G, Chavanon ML, Weise C. Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers. Trials. 2020 May 5;21(1):382. doi: 10.1186/s13063-020-04309-y.

  PMID: 32370767 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

Study Officials

• Cornelia Weise, Dr.

  Philipps Universität Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: May 27, 2018
• First Posted: June 8, 2018
• Study Start: October 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data available within one year of study completion
• Access Criteria: Data access request will be reviewed by the Principal Investigator. Requestors will be required to sign a data access agreement.

Locations

DE (1)