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TinnitusNeuroTinNCT05737888

Physiological Regulation of Chronic Tinnitus

A study testing fMRI Neurofeedback, EEG Neurofeedback and Cognitive Behavioral Therapy in people with Tinnitus, run by Wyss Center for Bio and Neuroengineering at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Tinnitus
What is being tested?
fMRI Neurofeedback, EEG Neurofeedback and Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteSwitzerland
Study dates
14 Feb 2017to 30 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 to 80 years
  • Tinnitus Handicap Inventory ≥ 48
  • Chronic, persistent, non-pulsatile tinnitus for minimum 6 months
  • Functional hearing
  • Normal inner ear structure assessment using an ear microscope, normal tympanic membrane mobility
  • Participant willing, able and available to participate in the entire research, including completion of questionnaires and traveling to research sites for the duration of the trial

Who cannot join

  • 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:
  • Known systemic disease (vestibular schwannoma, endolymphatic hydrops)
  • Lesion in central nervous system, including history of severe cranio-cerebral trauma
  • Acute ear canal or middle ear inflammation or effusion
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Dept. of Otology, Audiology and Cochlear Implant Surgery, University Hospital Geneva

    Geneva, Canton of Geneva, 1205

Other trials in Switzerland

About this study

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.

Read the 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
Being tested
fMRI Neurofeedback, EEG Neurofeedback, Cognitive Behavioral Therapy
Keywords
Tinnitus, EEG neurofeedback, fMRI neurofeedback, Cognitive behavioral therapy
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fMRI NeurofeedbackOther

    15 intervention sessions on a 3T MRI scanner.

  • EEG NeurofeedbackOther

    15 intervention sessions with a standard EEG-cap with 64 active electrodes.

  • Cognitive Behavioral TherapyBehavioural

    10 intervention sessions of CBT group therapy, as per local university hospital standard of care.

Study groups in NCT05737888
Study groupRoleWhat they receive
fMRI NeurofeedbackExperimentalThe 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.
Receives: Other: fMRI Neurofeedback
EEG NeurofeedbackExperimentalThe 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.
Receives: Other: EEG Neurofeedback
Cognitive Behavioral TherapyActive comparatorGroup 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.
Receives: Behavioral: Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 8 months

Secondary outcomes (6)

  1. Audiological measures

    If reported tinnitus scores correlate with audiological measures during research for each experimental group;

    Measured: 8 months

  2. Training effect

    If significant behavioral change as shown by a THI grade reduction is observed before/after experiment in each group;

    Measured: 8 months

  3. 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);

    Measured: 8 months

  4. 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;

    Measured: 8 months

  5. 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;

    Measured: 8 months

  6. Acceptance of intensive schedule

    Specifically for group 1 and 2, acceptance of neurofeedback intensive schedule of visits by participants.

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start14 Feb 2017
  3. Primary completion6 Dec 2022
  4. Study completion30 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective research with 3 independent research arms.
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737888
Sponsor's protocol ID
NeuroTin
Acronym
NeuroTin
Status last verified
Nov 2023
First submitted
10 Feb 2023
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41698286

  • 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.

    PubMed 38349241

Questions about this trial

What is this clinical trial studying?

A study testing fMRI Neurofeedback, EEG Neurofeedback and Cognitive Behavioral Therapy in people with Tinnitus, run by Wyss Center for Bio and Neuroengineering at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavioral improvement of tinnitus as measured by the Tinnitus Handicap Inventory (THI) (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05737888, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

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