TinnitusACCELANCT02853812
Tinnitus Related Cerebral Activities
A study testing Functional brain MRI in people with Tinnitus, run by University Hospital, Montpellier.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Functional brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2013to 27 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Functional brain MRI
- Keywords
- tinnitus, residual inhibition
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional brain MRIOther
Sound evoked functional MRI assessment on patients with single sided tinnitus
| Study group | Role | What they receive |
|---|---|---|
| single sided tinnitus | Other | patients with single sided tinnitus on which functional brain MRI is assessed Receives: Other: Functional brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the BOLD activity by MRI
Measure is done by MRI
Measured: 6 months
Secondary outcomes (1)
Measure of the BOLD activity on resting state by MRI
Measure is done by MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start5 Feb 2013
- Primary completion27 Aug 2015
- Study completion27 Aug 2015
Why it stopped: end of inclusion period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Venail, MD PhD, Study chair, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853812
- Sponsor's protocol ID
- 8847
- Acronym
- ACCELA
- Status last verified
- Dec 2021
- First submitted
- 27 Jul 2016
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinnitus Related Cerebral Activities: Personalised Approach of the Tinnitus Treatment
- ClinicalTrials.gov ID
- NCT02853812
- Acronym / sponsor ID
- ACCELA / 8847
- Conditions
- Tinnitus
- Keywords
- tinnitus, residual inhibition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of inclusion period
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Feb 2013 (actual)
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single sided tinnitus | Other | Other: Functional brain MRIpatients with single sided tinnitus on which functional brain MRI is assessed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional brain MRISound evoked functional MRI assessment on patients with single sided tinnitus | Other | single sided tinnitus |
Primary outcome
Measure of the BOLD activity by MRI
Time frame: 6 months
Measure is done by MRI
1 secondary outcome
Measure of the BOLD activity on resting state by MRI
Time frame: 6 months
Results and safety
The study was stopped early (reason given: end of inclusion period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Venail, MD PhD study chair
CHU de Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing Functional brain MRI in people with Tinnitus, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: end of inclusion period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the BOLD activity by MRI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.