Tinnitus, Tinnitus Aggravated, Tinnitus, Subjective
Conditions
Keywords
tinnitus, neurofeedback, non-pharmocological, functional MRI, real-time fMRI
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.
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.
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.
Sponsors
University of Illinois at Urbana-Champaign
Royal Royal National Institute for Deaf People (RNID)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will not be made aware whether they are recieving sham or real feedback
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Tinnitus Functional Index | 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
| Measure | Time frame | Description |
|---|---|---|
| Score on the Hospital Anxiety and Depression Scale | 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) |
| Percent-change in Functional Connectivity Strength from Baseline to Post-Intervention, participant-level | 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) |
Countries
United States
Contacts
CONTACTFatima T Husain, PhD
PRINCIPAL_INVESTIGATORFatima T Husain, PhD
University of Illinois Urbana-Champaign
Outcome results
None listed