Physiological Regulation of Chronic Tinnitus

NCT ID: NCT05737888

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-14
• Study Completion Date: 2023-03-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fMRI Neurofeedback

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.

Group Type: EXPERIMENTAL

fMRI Neurofeedback

Intervention Type: OTHER

15 intervention sessions on a 3T MRI scanner.

EEG Neurofeedback

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.

Group Type: EXPERIMENTAL

EEG Neurofeedback

Intervention Type: OTHER

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

Cognitive Behavioral Therapy

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Interventions

fMRI Neurofeedback

15 intervention sessions on a 3T MRI scanner.

Intervention Type: OTHER

EEG Neurofeedback

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

Intervention Type: OTHER

Cognitive Behavioral Therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age between 18 to 80 years

2. Tinnitus Handicap Inventory ≥ 48

3. Chronic, persistent, non-pulsatile tinnitus for minimum 6 months

4. Functional hearing

5. Normal inner ear structure assessment using an ear microscope, normal tympanic membrane mobility

6. 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

Exclusion Criteria

1. Contraindication to MRI (e.g. non compatible cochlear implant, pacemaker, deep brain stimulation)

2. Conductive hearing loss exceeding 20 dB at two or more frequencies

3. 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

4. Significant neurologic disease, psychiatric disease, substance abuse or acute allergic disease

5. Ongoing medication that is known to treat, influence, or cause tinnitus (e.g. high-dose aspirin, quinidine, aminoglycosides)

6. Ongoing or recent (completed since less than 4 weeks) tinnitus therapy (e.g. tinnitus maskers, acupuncture)

7. Participation in competitive or pharmacological study

8. Pregnant woman

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: collaborator

Wyss Center for Bio and Neuroengineering

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal Senn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 38349241 (View on PubMed)

Other Identifiers

NeuroTin

Identifier Type: -

Identifier Source: org_study_id