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NCT Number: NCT07788638

Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beckman Institute Biomedical Imaging Centre

Urbana, Illinois, 61820, United States

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

217-333-7561

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

neurofeedback-guided brain connectivity modulation

Behavioral

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 modulation

Behavioral

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

Primary outcomes

  1. Score on the Tinnitus Functional Index

    Time frame: Screening, post-intervention

    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).

Secondary outcomes

  1. Score on the Hospital Anxiety and Depression Scale

    Time frame: Screening, post-intervention

    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)

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

    Time frame: Pre-intervention, post-intervention

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Fatima T Husain, PhD

CONTACT

[email protected]

217-333-2230

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Royal Royal National Institute for Deaf People (RNID)

Registry information

Official study title

Targeted Neurofeedback Training to Alleviate Tinnitus Distress

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

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.

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