Neurofeedback for Tinnitus - Does Frequency Specificity Matter?

Philipps University

Status: Completed

Conditions: Subjective Tinnitus; Chronic Tinnitus; Tinnitus

Treatments: Behavioral: alpha/delta neurofeedback; Behavioral: beta/theta neurofeedback; Other: Diary completion

Study type: Interventional

Funder types: Other

Identifiers

NCT03550430

Neurofeedback for tinnitus

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

ADR neurofeedback

Experimental group

Description:

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.

Treatment:

Behavioral: alpha/delta neurofeedback

BTR neurofeedback

Active Comparator group

Description:

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.

Treatment:

Behavioral: beta/theta neurofeedback

Diary Control Group

Active Comparator group

Description:

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

Treatment:

Other: Diary completion