Physiological Regulation of Chronic Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      The present project involves research on humans with the aim to characterize the reduction of
      chronic, continuous, non-pulsatile and debilitating tinnitus in humans by comparing
      neurofeedback (fMRI or EEG) to the current gold standard behavioral cognitive therapy.
    

Detailed description: 
      Chronic tinnitus is affecting 10-15% of people typically for many decades, with increasing
      prevalence with aging. Multiple therapy forms for tinnitus exist (including cognitive
      behavioral therapy, external white noise stimulation, meditation, and various kinds of
      alternative approaches), but up to now, no generally accepted successful treatment exists.
      Previously, it was shown that voluntary control of the activation of the auditory cortex can
      be learned by means of real-time functional Magnetic Resonance Imaging (fMRI) neurofeedback,
      and that it may alleviate tinnitus symptoms. The same seems to hold for learned increase of
      alpha activity localized in the auditory cortex through electroencephalography (EEG)
      neurofeedback. Given the high prevalence of chronic tinnitus, its significant burden for
      affected individuals, and given the absence of generally effective therapy, neurofeedback
      training for tinnitus has the potential to become a clinical application.

      The main goal of this project is to comparatively assess tinnitus reduction using
      neurofeedback (fMRI or EEG) compared to cognitive behavioral therapy in participants with
      chronic severe tinnitus.

        -  The participants are assigned to 3 different experimental groups (EEG neurofeedback,
           fMRI neurofeedback, or cognitive behavioral therapy). The participation per subject will
           last from 4 to 12 months.

        -  The participants undergo medical tests including audiological tests as well as
           questionnaires related to tinnitus and quality of life at different timepoints of the
           study (pre and post training visits).

        -  At the end of the experimental visits, each participant will have one early and one late
           post-assessment evaluation visits.

        -  In order to evaluate the longer-term evolution of tinnitus over time, long-term
           follow-ups will be scheduled starting at 9 months after the final experimental visit,
           and will occur every 4.5 months thereafter, until research ends (for a maximum of 5
           years).
    

Intervention name(s): fMRI Neurofeedback; EEG Neurofeedback; Cognitive Behavioral Therapy
Intervention type(s): Other; Other; Behavioral
Intervention description(s): 15 intervention sessions on a 3T MRI scanner.; 15 intervention sessions with a standard EEG-cap with 64 active electrodes.; 10 intervention sessions of CBT group therapy, as per local university hospital standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective research with 3 independent research arms.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tinnitus; EEG neurofeedback; fMRI neurofeedback; Cognitive behavioral therapy