NCT02853812

Brief Summary

The proposed research is to identify the brain areas activated or deactivated by tinnitus in humans. The identification of these areas is expected to be able to treat tinnitus refractory to traditional therapies by methods of brain stimulation. Furthermore, this technique would be very useful to verify the effectiveness of any treatment to relieve tinnitus. The brain activation measured during fMRI will be performed in a position of rest, after inhibition of tinnitus, and after application of a sound that does not inhibit tinnitus. This comparison will identify specific brain areas activated or deactivated by tinnitus.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

2.6 years

First QC Date

July 27, 2016

Last Update Submit

December 27, 2021

Conditions

Tinnitus

Keywords

tinnitusresidual inhibition

Outcome Measures

Primary Outcomes (1)

  • Measure of the BOLD activity by MRI

    Measure is done by MRI

    6 months

Secondary Outcomes (1)

  • Measure of the BOLD activity on resting state by MRI

    6 months

Study Arms (1)

single sided tinnitus

OTHER

patients with single sided tinnitus on which functional brain MRI is assessed

Other: Functional brain MRI

Interventions

Functional brain MRIOTHER

Sound evoked functional MRI assessment on patients with single sided tinnitus

single sided tinnitus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age limits to \> 18 years and \< 70 years
  • Voluntary study participation
  • Unhurt of any acute or chronic pathology of the ear (except tinnitus and a possible deafness of perception in the limits fixed below) on the basis of the interrogation and of the clinical examination
  • presenting a single sided tinnitus
  • Presenting on the side of the tinnitus a phenomenon of residual inhibition with a duration of total disappearance of the tinnitus of more than 30 seconds
  • easily reached
  • informed consent signed
  • Affiliation or recipient with the mode of social security

You may not qualify if:

  • Subjects incapable to understand the nature and the purposes of the study and/or having difficulty of communication with the investigator
  • majors protected by the law or privated of liberty by judiciary or administrative decision
  • pregnant woman
  • Anomaly of the external or average ear
  • Tinnitus attributed to a clearly identified retro-cochlear origin
  • Deafness of transmission of more than 15 dB on the tonal audiometry
  • Deafness of perception of more than 60 dB in average hearing loss (arithmetic mean) on the frequencies of 0,5-1-2 and 4 kHz.
  • Renowned ototoxic treatment during the duration of the protocol (malaria medicines, ototoxic chemotherapy, ototoxic antibiotic treatment),
  • Pursuit of a noise exposure of strong intensity with title professional and/or of leisure, dental treatment with use of engine or turbine, during the duration of the protocol.
  • Contraindication in the examination MRI (pacemaker, port of surgical clips in the cervico-cephalic region or implanted medical surgical material susceptible to mobilize under the influence of magnetic gradients, foreign body intraocular, pieces of shrapnel at the cervico-cephalic level (possibility of artefact), claustrophobia, pregnancy of less than 3 months)
  • History of cranial trauma with encephalic infringement(achievement), ischemic cerebrovascular accident or intracerebral bruise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic Venail, MD PhD

    CHU de Montpellier

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 3, 2016

Study Start

February 5, 2013

Primary Completion

August 27, 2015

Study Completion

August 27, 2015

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share