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Tinnitus Related Cerebral Activities

Tinnitus Related Cerebral Activities: Personalised Approach of the Tinnitus Treatment

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02853812
Acronym
ACCELA
Enrollment
24
Registered
2016-08-03
Start date
2013-02-05
Completion date
2015-08-27
Last updated
2021-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Keywords

tinnitus, residual inhibition

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

1. 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. 2. 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. 3. 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.

Interventions

Sound evoked functional MRI assessment on patients with single sided tinnitus

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measure of the BOLD activity by MRI6 monthsMeasure is done by MRI

Secondary

MeasureTime frameDescription
Measure of the BOLD activity on resting state by MRI6 monthsMeasure is done by MRI

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026