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Tinnitus Related Cerebral Activities (ACCELA)

Primary Purpose

Tinnitus

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Functional brain MRI

About this trial

This is an interventional basic science trial for Tinnitus focused on measuring tinnitus, residual inhibition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
instable tinnitus (difference upper than 3 on mean of the EVA realised during the 5 days before the inclusion)
insufficient tinnitus intensity (mean of the EVA realised during the 5 days before the inclusion<4)
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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single sided tinnitus

Arm Description

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

Outcomes

Primary Outcome Measures

Measure of the BOLD activity by MRI

Measure is done by MRI

Secondary Outcome Measures

Measure of the BOLD activity on resting state by MRI

Measure is done by MRI

Full Information

NCT ID

NCT02853812

First Posted

July 27, 2016

Last Updated

December 27, 2021

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02853812

Brief Title

Tinnitus Related Cerebral Activities

Acronym

ACCELA

Official Title

Tinnitus Related Cerebral Activities: Personalised Approach of the Tinnitus Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

end of inclusion period

Study Start Date

February 5, 2013 (Actual)

Primary Completion Date

August 27, 2015 (Actual)

Study Completion Date

August 27, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

What is the purpose of the research? 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. What is the methodology? This is a diagnosis based on functional brain imaging with MRI (fMRI). The study will be conducted in 30 subjects with unilateral tinnitus, stable lesion of origin and can be inhibited by masking sound. 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. What are the expected benefits? Direct individual benefit could possibly be met by participants in this study. Indeed, the determination of a masking noise can afford to set up a masking system to reduce the tinnitus if the patient wishes. Moreover, in case of identification of brain areas activated or inactivated by tinnitus in a subject, it may propose to carry out a transcranial magnetic brain stimulation of the area in an attempt to relieve the tinnitus, according to the stimulation protocols to date for tinnitus. This will achieved a personalized approach to treating tinnitus. Besides the expected individual benefit, other expected benefits are collective order, given the highly variable success rates, but generally limited treatments against tinnitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus

Keywords

tinnitus, residual inhibition

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single sided tinnitus

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Functional brain MRI

Intervention Description

Sound evoked functional MRI assessment on patients with single sided tinnitus

Primary Outcome Measure Information:

Title

Measure of the BOLD activity by MRI

Description

Measure is done by MRI

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Measure of the BOLD activity on resting state by MRI

Description

Measure is done by MRI

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 instable tinnitus (difference upper than 3 on mean of the EVA realised during the 5 days before the inclusion) insufficient tinnitus intensity (mean of the EVA realised during the 5 days before the inclusion<4) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic Venail, MD PhD

Organizational Affiliation

CHU de Montpellier

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

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