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Neurofeedback for Tinnitus - Does Frequency Specificity Matter?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03550430
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : November 9, 2020
Sponsor:
Collaborators:
Eriksholm Research Centre
Linkoeping University
University Hospital of Gießen and Marburg
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

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.

Condition or disease Intervention/treatment Phase
Tinnitus Subjective Tinnitus Chronic Tinnitus Behavioral: alpha/delta neurofeedback Behavioral: beta/theta neurofeedback Other: Diary completion Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: ADR neurofeedback
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
neurofeedback training protocol seeking to decrease the alpha/delta ratio, by simultaneous rewarding alpha and inhibiting delta activity.

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

Active Comparator: Diary Control Group
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
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Satisfaction with treatment [ Time Frame: 3 months ]
    self-developed scale to assess satisfaction with neurofeedback



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic subjective tinnitus, i.e. tinnitus with a duration > 6 months
  • At least moderate tinnitus distress, corresponding to a score of > 38 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550430


Locations
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Germany
Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
Marburg, Hessen, Germany, 35037
Sponsors and Collaborators
Philipps University Marburg Medical Center
Eriksholm Research Centre
Linkoeping University
University Hospital of Gießen and Marburg
Investigators
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Principal Investigator: Cornelia Weise, Dr. Philipps Universität Marburg
Publications:
Gräfe, K., Zipfel, S., Herzog, W., & Löwe, B. (2004). Screening psychischer Störungen mit dem "Gesundheitsfragebogen für Patienten (PHQ-D)". Diagnostica, 50(4), 171-181.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03550430    
Other Study ID Numbers: Neurofeedback for tinnitus
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philipps University Marburg Medical Center:
tinnitus distress
tinnitus intrusiveness
synchronization by loss of inhibition model (SLIM)
neurofeedback
alpha/delta neurofeedback
beta/theta neurofeedback
electroencephalography (EEG)
tinnitus intensity
tinnitus loudness
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases