Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress

NCT07788638 | Recruiting

• 1 other identifier: IRB24-1472
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus Aggravated; Tinnitus; Tinnitus, Subjective

Keywords

tinnitus; neurofeedback; non-pharmocological; functional MRI; real-time fMRI

Outcome Measures

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).

  Screening, post-intervention

Secondary Outcomes (2)

• Score on the Hospital Anxiety and Depression Scale

  Screening, post-intervention

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

  Pre-intervention, post-intervention

Study Arms (2)

Real feedback

EXPERIMENTAL

The participant will recieve real feedback of their ongoing brain activity

Behavioral: neurofeedback-guided brain connectivity modulation

Sham feedback

SHAM COMPARATOR

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

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.

Real feedback

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.

Sham feedback

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Royal Royal National Institute for Deaf People (RNID): collaborator

Study Sites (1)

Beckman Institute Biomedical Imaging Centre

Urbana, Illinois, 61820, United States

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatima T Husain, PhD

  University of Illinois Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima T Husain, PhD

CONTACT

217-333-2230; tinnitus-ACNLab@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not be made aware whether they are recieving sham or real feedback
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: August 12, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

US (1)