Skip to main content
OpenTrials
Completed

NCT Number: NCT03550430

Neurofeedback for Tinnitus - Does Frequency Specificity Matter?

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Marburg, Hesse, 35037, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alpha/delta neurofeedback

Behavioral

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

beta/theta neurofeedback

Behavioral

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

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.

Primary outcomes

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

    Time frame: 16 weeks

    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).

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

    Time frame: 16 weeks

    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.

Secondary outcomes

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

    Time frame: 16 weeks

    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%.

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

    Time frame: 4 weeks

    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.

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

    a quick and easy-to-administer scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies

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

    Time frame: 16 weeks

    measures the ability to sustain attention

  6. Attention Network Test (ANT; Fan, McCandliss, Sommer, Raz, & Posner, 2002)

    Time frame: 16 weeks

    assesses orienting, alerting and executive attention processing respectively

  7. Patient Health Questionnaire (PHQ-9; Gräfe, Zipfel, Herzog, & Löwe, 2004)

    Time frame: 16 weeks

    Assessment of depressive symptoms

Other outcomes

  1. Satisfaction with treatment

    Time frame: 3 months

    self-developed scale to assess satisfaction with neurofeedback

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Eriksholm Research Centre
  • Linkoeping University
  • University Hospital Giessen and Marburg

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2018
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.