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Tinnitus Related Cerebral Activities (ACCELA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853812
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Montpellier.
Recruitment status was:  Active, not recruiting
First Posted : August 3, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Tinnitus Other: Functional brain MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tinnitus Related Cerebral Activities: Personalised Approach of the Tinnitus Treatment
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
single sided tinnitus
patients with single sided tinnitus on which functional brain MRI is assessed
Other: Functional brain MRI
Sound evoked functional MRI assessment on patients with single sided tinnitus




Primary Outcome Measures :
  1. Measure of the BOLD activity by MRI [ Time Frame: 6 months ]
    Measure is done by MRI


Secondary Outcome Measures :
  1. Measure of the BOLD activity on resting state by MRI [ Time Frame: 6 months ]
    Measure is done by MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853812


Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Chair: Frederic Venail, MD PhD CHU de Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02853812    
Other Study ID Numbers: 8847
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
tinnitus
residual inhibition
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms