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| Name | Class |
|---|---|
| Ecole Polytechnique Fédérale de Lausanne | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fMRI Neurofeedback | Experimental | The participants receive visual feedback (displayed on a screen) related to BOLD activity from their auditory cortices, and they are asked to learn to down-regulate it. |
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| EEG Neurofeedback | Experimental | The participants receive visual feedback (displayed on a screen) related to the ratio of alpha to delta localized activity from their auditory cortices, and they are asked to learn to up-regulate it. |
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| Cognitive Behavioral Therapy | Active Comparator | Group therapy is provided by trained clinicians for research participants. Participants are confronted with tinnitus-inducting situations and trained to use diverse cognitive and behavioral coping skills to reduce the subjective impact of tinnitus burden. Such coping skills include relaxation, distraction, and de-catastrophizing, among other strategies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fMRI Neurofeedback | Other | 15 intervention sessions on a 3T MRI scanner. |
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| Measure | Description | Time Frame |
|---|---|---|
| Behavioral improvement of tinnitus as measured by the Tinnitus Handicap Inventory (THI) | To show that behavioral improvement of tinnitus after intensive neurofeedback training is equivalent or better than improvement obtained after attending group cognitive behavioral therapy, as measured by Tinnitus Handicap Inventory (THI) scores reported before experiment and at late post-assessment (significant difference, p-value < 0.05). THI ranges from low scores (grade 1 - slight or no handicap), to highest scores (grade 5 - catastrophic handicap). | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Audiological measures | If reported tinnitus scores correlate with audiological measures during research for each experimental group; | 8 months |
| Training effect | If significant behavioral change as shown by a THI grade reduction is observed before/after experiment in each group; |
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Inclusion Criteria:
Exclusion Criteria:
Contraindication to MRI (e.g. non compatible cochlear implant, pacemaker, deep brain stimulation)
Conductive hearing loss exceeding 20 dB at two or more frequencies
Known diagnoses causing tinnitus or hearing loss:
Significant neurologic disease, psychiatric disease, substance abuse or acute allergic disease
Ongoing medication that is known to treat, influence, or cause tinnitus (e.g. high-dose aspirin, quinidine, aminoglycosides)
Ongoing or recent (completed since less than 4 weeks) tinnitus therapy (e.g. tinnitus maskers, acupuncture)
Participation in competitive or pharmacological study
Pregnant woman
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Senn, MD, PhD | Dept. of Otology, Audiology and Cochlear Implant Surgery, University Hospital Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Otology, Audiology and Cochlear Implant Surgery, University Hospital Geneva | Geneva | Canton of Geneva | 1205 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41698286 | Derived | Gninenko N, Senn P, Haller S, Van De Ville D. Altered parietal multisensory integration in chronic tinnitus during closed-loop real-time fMRI auditory downregulation. Neuroimage Clin. 2026;49:103960. doi: 10.1016/j.nicl.2026.103960. Epub 2026 Feb 12. | |
| 38349241 | Derived | Gninenko N, Trznadel S, Daskalou D, Gramatica L, Vanoy J, Voruz F, Robyn CL, Spadazzi A, Yulzari A, Sitaram R, Van De Ville D, Senn P, Haller S. Functional MRI Neurofeedback Outperforms Cognitive Behavioral Therapy for Reducing Tinnitus Distress: A Prospective Randomized Clinical Trial. Radiology. 2024 Feb;310(2):e231143. doi: 10.1148/radiol.231143. |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Prospective research with 3 independent research arms.
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| EEG Neurofeedback |
| Other |
15 intervention sessions with a standard EEG-cap with 64 active electrodes. |
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| Cognitive Behavioral Therapy | Behavioral | 10 intervention sessions of CBT group therapy, as per local university hospital standard of care. |
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| 8 months |
| Other factors | If there are external parameters influencing reported tinnitus levels for each group during the research, based on participant questionnaires (i.e., placebo effect of the trainer/CBT professional provider, motivation levels); | 8 months |
| Correlation with BOLD signal | Specifically for group 1 - fMRI neurofeedback, whether evolution of audiological and tinnitus measures at different research timepoints correlate with BOLD signal of the auditory cortex; | 8 months |
| Correlation with alpha activity | Specifically for group 2 - EEG neurofeedback, whether evolution of audiological and tinnitus measures at different research timepoints correlate with alpha activity of the auditory cortex; | 8 months |
| Acceptance of intensive schedule | Specifically for group 1 and 2, acceptance of neurofeedback intensive schedule of visits by participants. | 8 months |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |