- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853812
Tinnitus Related Cerebral Activities (ACCELA)
Tinnitus Related Cerebral Activities: Personalised Approach of the Tinnitus Treatment
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: single sided tinnitus
patients with single sided tinnitus on which functional brain MRI is assessed
|
Sound evoked functional MRI assessment on patients with single sided tinnitus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of the BOLD activity by MRI
Time Frame: 6 months
|
Measure is done by MRI
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of the BOLD activity on resting state by MRI
Time Frame: 6 months
|
Measure is done by MRI
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Frederic Venail, MD PhD, CHU de Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8847
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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