Health TrialsbyHealthPanel

Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress

ConditionsTinnitus AggravatedTinnitusTinnitus, Subjective
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Illinois at Urbana-Champaign

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Real feedbackExperimental treatment 1 intervention
Group B: Sham feedbackSham comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Urbana-Champaign

Lead sponsor

Royal Royal National Institute for Deaf People (RNID)

Collaborator

Source ClinicalTrials.gov
Apply now