Advanced Neurofeedback for Tinnitus
ConditionTinnitus, Subjective
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Zurich
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Neurofeedback
Other interventionindividualized, norm-based EEG neurofeedback
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Real NFB - Sham NFBOther 1 intervention
Group B: Sham NFB - Real NFBOther 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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)2
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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