Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress

University of Illinois at Urbana-Champaign20 enrolled

Overview

The broad goals of this project are to apply and validate the therapeutic utility of neurofeedback-guided intervention for tinnitus and its associated psychological sufferings. In this project, the investigators will evaluate whether targeted (non-auditory networks) neurofeedback-based training can restore emotional and cognitive health for individuals with bothersome tinnitus. The investigators will also link individual tinnitus scores with objective brain imaging measures before, during, and after the intervention. The investigators will accomplish these goals by using a combined brain imaging and behavioral experimental framework.

Intervention via neurofeedback has shown promising results for many neurological disorders including schizophrenia, post-traumatic stress disorder, ADHD, anxiety and major depressive disorder, with benefits lasting over several weeks after the completion of training ; neurofeedback-guided training has led to participants successfully alter activity in brain regions that mediate emotional response, mood and cognitive control. Because these brain regions and functions are also implicated in bothersome tinnitus, real-time neurofeedback training based on ongoing activity in these targets can potentially improve the psychological distress associated with tinnitus severity. Real-time neurofeedback can provide a valuable training tool for coping with tinnitus-related distress and help underpin the development of intervention-based treatments.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tinnitus Aggravated

Interventions

neurofeedback-guided brain connectivity modulationBEHAVIORAL

Real-time brain signal acquired through fMRI is used to measure ongoing functional connectivity of relevant brain regions (default mode network), and displayed to participants to mediate targeted regulation.

sham neurofeedback-guided brain connectivity modulationBEHAVIORAL

Real-time brain signal acquired through fMRI on a different participant in the past is displayed to participants under this arm during feedback training.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-pulsatile tinnitus for at least 6 months, * Bothersome tinnitus, based on a Tinnitus Functional Index score \> 25, * Normal cognitive processing abilities, based on a Montreal Cognitive Assessment score\> 25. Exclusion Criteria: * Clinically diagnosed dementia or Parkinson's disease, * Meniere's disease, * Severe physical or cognitive impairments that prevent completion of study tasks or scanning, * History of drug or alcohol abuse, * History of psychological or neurological illness, except for managed anxiety or depression, * Severe chronic health problems other than hearing loss or tinnitus, * Vision that is not normal or not corrected to normal, * Unable to meet MRI clinical safety screening requirements (e.g., metal in the body, pregnancy, certain implantable devices).

Outcomes

Primary Outcomes

Score on the Tinnitus Functional Index

The Tinnitus Functional Index (TFI) is a 25-item self-report questionnaire designed to measure the impact of tinnitus on an individual's daily life and functioning. The scale produces a global score ranging from 0 to 100, where a minimum score of 0 represents no impact and a maximum score of 100 represents severe impact. Higher scores indicate a worse outcome (greater tinnitus severity and distress).

Time frame: Screening, post-intervention

Secondary Outcomes

Score on the Hospital Anxiety and Depression Scale

The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire used to screen for anxiety and depression in medical settings. Higher scores indicate a worse outcome. Unit of Measure: Score on a scale (0-21)

Time frame: Screening, post-intervention

Percent-change in Functional Connectivity Strength from Baseline to Post-Intervention, participant-level

This measure evaluates changes in brain functional connectivity in the default mode network using functional Magnetic Resonance Imaging (fMRI), which is a correlation coefficient of brain activity. This will be measured for each participant. Unit: percentage (change in correlation coefficient)

Time frame: Pre-intervention, post-intervention