Physiological Regulation of Chronic Tinnitus

NCT05737888 | Completed

• 1 other identifier: NeuroTin
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Tinnitus; EEG neurofeedback; fMRI neurofeedback; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (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).

  8 months

Secondary Outcomes (6)

• Audiological measures

  8 months

• Training effect

  8 months

• Other factors

  8 months

• Correlation with BOLD signal

  8 months

• Correlation with alpha activity

  8 months

Study Arms (3)

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.

Other: fMRI Neurofeedback

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.

Other: EEG Neurofeedback

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.

Behavioral: Cognitive Behavioral Therapy

Interventions

fMRI Neurofeedback OTHER

15 intervention sessions on a 3T MRI scanner.

fMRI Neurofeedback

EEG Neurofeedback OTHER

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

EEG Neurofeedback

Cognitive Behavioral Therapy BEHAVIORAL

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

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wyss Center for Bio and Neuroengineering: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

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

Geneva, Canton of Geneva, 1205, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 38349241 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pascal Senn, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective research with 3 independent research arms.

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: February 14, 2017
• Primary Completion: December 6, 2022
• Study Completion: March 30, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)