Tinnitus AggravatedNCT07788638
Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress
A study testing neurofeedback-guided brain connectivity modulation in people with Tinnitus Aggravated and Tinnitus, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus Aggravated, Tinnitus, Tinnitus, Subjective
- What is being tested?
- neurofeedback-guided brain connectivity modulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beckman Institute Biomedical Imaging Centre
Urbana, Illinois, 61820
Principal Investigator, 217-333-7561, tinnitus-ACNLab@illinois.edu
About this study
Official title: Targeted 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.
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.
- Conditions
- Tinnitus Aggravated, Tinnitus, Tinnitus, Subjective
- Being tested
- neurofeedback-guided brain connectivity modulation, sham neurofeedback-guided brain connectivity modulation
- Keywords
- tinnitus, neurofeedback, non-pharmocological, functional MRI, real-time fMRI
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurofeedback-guided brain connectivity modulationBehavioural
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 modulationBehavioural
Real-time brain signal acquired through fMRI on a different participant in the past is displayed to participants under this arm during feedback training.
| Study group | Role | What they receive |
|---|---|---|
| Real feedback | Experimental | The participant will recieve real feedback of their ongoing brain activity Receives: 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 Receives: Behavioral: sham neurofeedback-guided brain connectivity modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Screening, post-intervention
Secondary outcomes (2)
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)
Measured: 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)
Measured: Pre-intervention, post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start12 Aug 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus AggravatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Royal National Institute for Deaf People (RNID)
- Responsible party
- Principal investigator, Fatima Husain, University of Illinois at Urbana-Champaign
- Investigators
- Fatima T Husain, PhD, Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788638
- Sponsor's protocol ID
- IRB24-1472
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Neurofeedback Training to Alleviate Tinnitus Distress
- ClinicalTrials.gov ID
- NCT07788638
- Acronym / sponsor ID
- IRB24-1472
- Conditions
- Tinnitus Aggravated, Tinnitus, Tinnitus, Subjective
- Keywords
- tinnitus, neurofeedback, non-pharmocological, functional MRI, real-time fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Royal Royal National Institute for Deaf People (RNID)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real feedback | Experimental | Behavioral: neurofeedback-guided brain connectivity modulationThe participant will recieve real feedback of their ongoing brain activity |
| Sham feedback | Sham comparator | Behavioral: sham neurofeedback-guided brain connectivity modulationThe participant will recieve pseudo feedback of brain activity, which may be from a non-related brain region, or from another participant's data |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurofeedback-guided brain connectivity modulationReal-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. | Behavioural | Real feedback |
| sham neurofeedback-guided brain connectivity modulationReal-time brain signal acquired through fMRI on a different participant in the past is displayed to participants under this arm during feedback training. | Behavioural | Sham feedback |
Primary outcome
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).
2 secondary outcomes
Score on the Hospital Anxiety and Depression Scale
Time frame: Screening, post-intervention
Percent-change in Functional Connectivity Strength from Baseline to Post-Intervention, participant-level
Time frame: Pre-intervention, post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatima T Husain, PhD principal investigator
University of Illinois Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurofeedback-guided brain connectivity modulation in people with Tinnitus Aggravated and Tinnitus, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatima T Husain, PhD (217-333-2230, tinnitus-ACNLab@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Tinnitus Functional Index (time frame: Screening, post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.