Advanced Neurofeedback for Tinnitus

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.

Inclusion Criteria: * Healthy female or male or diverse patients 18 years to 65 years of age * Persistent chronic, subjective tinnitus with duration of more than 3 months * Signed informed consent after being informed about the study * Fluent in German * Tinnitus with a THI Grade 2 to 4 (18-76 points), moderate to severe * Willing and able to attend all study visits Exclusion Criteria: * Hyperacusis * Concurrent neurological or psychiatric disorders * Regular intake of medication influencing the central nervous system (e.g. neuroleptics, hypnotics, sedatives, and anti-epileptics) * Somatic tinnitus * Asymmetrical hearing (more than 20dB side difference), pantonal hearing loss \> 40dB in any measured frequency up to 2kHz * Women who are pregnant and/or breast feeding * Intention to become pregnant during the course of the study * Known or suspected drug or alcohol abuse * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Enrolment of the investigator, his/her family members, employees and other dependent persons