ClinicalTrials.gg
RecruitingNCT07788638Updated Aug 26, 2026

Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress

An interventional study of neurofeedback-guided brain connectivity modulation and sham neurofeedback-guided brain connectivity modulation in Tinnitus Aggravated, Tinnitus and Tinnitus, Subjective, sponsored by University of Illinois at Urbana-Champaign. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Tinnitus Aggravated
  • Tinnitus
  • Tinnitus, Subjective

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Keywords

  • tinnitus
  • neurofeedback
  • non-pharmocological
  • functional MRI
  • real-time fMRI
03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

University of Illinois at Urbana-Champaign is the lead sponsor of 191 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 score> 25.

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Real feedback

    The participant will recieve real feedback of their ongoing brain activity

    Behavioral: neurofeedback-guided brain connectivity modulation

  • Sham comparator
    Sham feedback

    The participant will recieve pseudo feedback of brain activity, which may be from a non-related brain region, or from another participant's data

    Behavioral: sham neurofeedback-guided brain connectivity modulation

Interventions

  • Behavioralneurofeedback-guided brain connectivity modulation

    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.

  • Behavioralsham neurofeedback-guided brain connectivity modulation

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
  • Beckman Institute Biomedical Imaging Centre
    Urbana, Illinois 61820, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07788638
Collaborators
Royal Royal National Institute for Deaf People (RNID)
Responsible party
Fatima Husain (Professor, University of Illinois at Urbana-Champaign) — Principal investigator
First posted
Aug 26, 2026
Start date
Aug 12, 2026
Primary completion
Dec 15, 2026 (estimated)
Completion
Apr 15, 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Fatima T Husain, PhD
Contact
tinnitus-ACNLab@illinois.edu
217-333-2230
Fatima T Husain, PhD
principal investigator · University of Illinois Urbana-Champaign

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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