NCT05737888

Physiological Regulation of Chronic Tinnitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Wyss Center for Bio and Neuroengineering · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tinnitus

Interventions

Type	Name	Description
OTHER	fMRI Neurofeedback	15 intervention sessions on a 3T MRI scanner.
OTHER	EEG Neurofeedback	15 intervention sessions with a standard EEG-cap with 64 active electrodes.
BEHAVIORAL	Cognitive Behavioral Therapy	10 intervention sessions of CBT group therapy, as per local university hospital standard of care.

Timeline

• Start date: 2017-02-14
• Primary completion: 2022-12-06
• Completion: 2023-03-30
• First posted: 2023-02-21
• Last updated: 2023-11-14

Locations

1 site across 1 country: Switzerland