Neurofeedback for Tinnitus - Does Frequency Specificity Matter?

Tinnitus Clinical Trial

Official title:

Study Protocol for a Single-blind Randomized Controlled Trial, Assessing the Specificity of an Alpha/Delta Ratio Neurofeedback Training Protocol in Chronic Tinnitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550430
• Other study ID #: Neurofeedback for tinnitus
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2021
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Tinnitus is hypothesized to originate as a result of a disturbance in the balance of excitatory and inhibitory neurons in central auditory structures. More specifically, inhibitory neurons hyperpolarize, by which their functional role is weakened . Consequently, this allows auditory neurons, deprived of input from a lesioned auditory system, to spontaneously synchronize their activity, resulting in the tinnitus percept.

In the normal functioning auditory system, neurons firing synchronously in the alpha frequency region (8 - 12 Hz) have a gating function of inhibiting task-irrelevant regions in the brain. In people with chronic tinnitus, it has been observed, that alpha activity over temporal regions is weakened, thus leading to the spontaneous activity characterizing the condition. By upregulating alpha activity with neurofeedback training, it is hypothesized that the excitatory/inhibitory balance in temporal regions can be restored, thus minimizing the tinnitus percept.

The coupling or exchange of information of distinct brain regions, leading to an integrated conscious perception, is assumed to be mediated by delta oscillations. In tinnitus, the distress associated with the condition arises as a consequence of coupling prefrontal areas, responsible for allocation of attentional resources with limbic (arousal) and temporal (auditory processing) regions. In neurofeedback, the downregulation of delta activity is hypothesized to lead to a de-coupling of the communication between the areas associated with the distress.

No studies to date have tested the specific role of alpha and delta in the origin and perpetuation of tinnitus distress and intrusiveness. The present study seeks to compensate for this, by comparing an alpha and delta neurofeedback ratio training protocol with one assumed to have no direct association with the pathophysiology of tinnitus.

In addition to the ten neurofeedback training sessions, all participants undergo diagnostic assessments at three time points throughout the trial (pre-neurofeedback training, post-neurofeedback training and at three months follow-up). For the first 40 participants, electroencephalographic (EEG) activity is recorded and cognitive capacity assessed with two attention tests, the Attention Network Test and Sustained Attention Response Task, respectively at all three time points. For the remaining 80 participants, the EEG recording is abandoned, and only cognitive capacity assessed in the pre- post, and follow-up phase of the study.

EEG recording and attention processes is similarly measured in a control group (n=40) at the pre-neurofeedback training stage. The group is comprised of healthy, age and gender matched participants. Their inclusion serve the purpose of comparing the brain activity, both at rest and during cognitive activity between people with- and people without tinnitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Tinnitus
• Subjective Tinnitus
• Tinnitus

Intervention

Behavioral:
• alpha/delta neurofeedback
neurofeedback training protocol seeking to decrease the alpha/delta ratio, by simultaneous rewarding alpha and inhibiting delta activity.
• beta/theta neurofeedback
neurofeedback training protocol seeking to decrease the beta/theta ratio, by simultaneous rewarding beta and inhibiting theta activity.

Other:
• Diary completion
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.

Locations

Country	Name	City	State
Germany	Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy	Marburg	Hessen

Sponsors (4)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Eriksholm Research Centre, Linkoeping University, University Hospital of Gießen and Marburg

Country where clinical trial is conducted

Germany, 

References & Publications (13)

Balkenhol T, Wallhäusser-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. — View Citation

Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. — View Citation

Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. — View Citation

Brüggemann 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. — View Citation

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. — View Citation

Dohrmann K, Weisz N, Schlee W, Hartmann T, Elbert T. Neurofeedback for treating tinnitus. Prog Brain Res. 2007;166:473-85. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Weisz N, Hartmann T, Müller 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with treatment	self-developed scale to assess satisfaction with neurofeedback	3 months
Primary	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
Primary	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	Tinnitus Functional Index (TFI; Brüggemann, Szczepek, Kleinjung, Ojo, & Mazurek, 2017)	The Tinnitus Functional Index (TFI) is a self-report measure of both perceived severity and negative impact of tinnitus. It covers multiple severity domains including but not exclusively quality of sleep, relaxation, sense of control. The TFI questionnaire consists of 25 items, predominantly scored between 0 - 10 bar item 1 and 3, which are expressed as percentages from 0 - 100%.	16 weeks
Secondary	Brief Illness Perception Questionnaire (B-IPQ; Broadbent, Petrie, Main, & Weinman, 2006)	The B-IPQ is a nine item self-report measure of individual cognitive and emotional representations of illness. It includes the following domains: consequences of the illness; perception of duration of illness; control over illness; treatment control; symptoms; understanding of illness; emotional response and causes.	4 weeks
Secondary	Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001)	A brief scanning measure of insomnia. It consists of 7 items assessing insomnia severity, interference in daily functioning, noticeability of impairment and distress/concern about sleep problems.	4 weeks
Secondary	Credibility and Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)	a quick and easy-to-administer scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies	4 weeks
Secondary	Sustained Attention Response Task (SART; Robertson, Manly, Andrade, Baddeley, & Yiend, 1997)	measures the ability to sustain attention	16 weeks
Secondary	Attention Network Test (ANT; Fan, McCandliss, Sommer, Raz, & Posner, 2002)	assesses orienting, alerting and executive attention processing respectively	16 weeks
Secondary	Patient Health Questionnaire (PHQ-9; Gräfe, Zipfel, Herzog, & Löwe, 2004)	Assessment of depressive symptoms	16 weeks