This study investigates neurofeedback as a potential treatment for chronic tinnitus. Neurofeedback is a non-invasive method that aims to regulate brain activity and may help reduce tinnitus symptoms and the distress associated with them. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of this treatment. The study duration is approximately nine months, including follow-up assessments. Participants attend 25 study visits, consisting of 20 neurofeedback treatment sessions and 5 assessment appointments. The study follows a randomized, placebo-controlled crossover design, meaning all participants receive both active neurofeedback and placebo neurofeedback in different sequences. The placebo provides feedback that is not based on real-time brain activity and serves as a control to ensure reliable scientific results. Direct personal benefits cannot be guaranteed; however, participation may contribute to improved understanding and future treatment of tinnitus. A reduction in tinnitus symptoms is possible. Neurofeedback is an established and safe, non-invasive technique. The specific method examined in this study is newly developed and has not yet been tested. Although no significant side effects are currently known, unforeseen risks cannot be entirely excluded. Overall, the study is classified as a low-risk clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
individualized, norm-based EEG neurofeedback
Behavioral - Minimal Masking Level
Changes in tinnitus intensity measured with audiometric testing: \- MML (Minimal Masking Level) in dB SL
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Behavioral - Numeric Rating Scale
Changes of tinnitus intensity and distress measured with questionnaires: \- NRS (Numeric Rating Scale) on a 11- point Likert scale from 0 to 10
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Behavioral - Tinnitus Functional Index
Changes of tinnitus intensity and distress measured with questionnaires: \- TFI (Tinnitus Functional Index) with a score between 0 and 100
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Behavioral - Tinntitus Handicap Inventory
Changes of tinnitus intensity and distress measured with questionnaires: \- THI (Tinntitus Handicap Inventory) with a score between 0 and 100
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Neurophysiological - neural features
Changes in individually-defined neural targets, so called neural features (e.g., EEG power, connectivity)
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Neurophysiological - Correlation between the behavioral changes and neurophysiological changes.
Correlation between the behavioral changes (NRS, TFI, THI) and neurophysiological changes.
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
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