TinnitusNCT01944501
Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss
A study testing Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation in people with Tinnitus and Hearing Loss, run by University of Brasilia at 1 site in Brazil.
Trial summary
This study aimed at trying transcranial magnetic stimulation and transcranial direct current stimulation as potential treatments to decrease tinnitus in patients with significant hearing loss. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Tinnitus, Hearing Loss
- What is being tested?
- Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Dec 2012
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic tinnitus
- hearing loss
Who cannot join
- neurological diseases
- use of drugs affecting the central nervous system
- evidence of dementia
- clinical diagnosis of depression
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed at trying transcranial magnetic stimulation and transcranial direct current stimulation as potential treatments to decrease tinnitus in patients with significant hearing loss.
Read the detailed description
Tinnitus is a very common condition and affects approximately 15% of the population, disrupting sleep, emotional balance and social life of the patients. Acoustic deprivation causes hearing loss and is responsible for a cascade of processes that result in the reorganization of the cortex through a synchronization of neuronal activity related to a cortical re-mapping. Consistent with the hypothesis that tinnitus is caused by abnormal activation of the auditory cortex, repetitive transcranial magnetic stimulation (rTMS) can temporarily reduce cortical hyperactivity through direct neuromodulation of the temporal cortex. Furthermore, studies have shown that transcranial direct current stimulation (tDCS) can also suppress tinnitus. Objective: To determine the effectiveness of rTMS and TDCS in the treatment of patients with chronic tinnitus and auditory loss. Methods: We performed an analytical experimental double-blind study using rTMS and tDCS in patients with chronic tinnitus and hearing loss.
- Conditions
- Tinnitus, Hearing Loss
- Keywords
- tinnitus, hearing loss, Transcranial magnetic stimulation, Transcranial direct current stimulation
- Medical subject headings
- Tinnitus, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationProcedure or surgery
TMS over the left temporoparietal cortex
Transcranial Direct Current StimulationProcedure or surgery
TDCS over the left temporoparietal cortex
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Active comparator | Patients receiving real transcranial magnetic stimulation Receives: Procedure: Transcranial Magnetic Stimulation |
| Sham TMS | Placebo comparator | Patients receiving sham transcranial magnetic stimulation Receives: Procedure: Transcranial Magnetic Stimulation |
| Transcranial Direct Current Stimulation | Active comparator | Patients receiving real transcranial direct current stimulation Receives: Procedure: Transcranial Direct Current Stimulation |
| Sham TDCS | Placebo comparator | Patients receiving sham transcranial direct current stimulation Receives: Procedure: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tinnitus Handicap Inventory (THI) scores
Measured: THI was measured before intervention (baseline) and after 5 daily sessions (day 5)
Secondary outcomes (1)
Change in Visual Analog Scale scores
Measured: Visual analog scale of tinnitus was recorded at baseline and after daily 5 TMS or TDCS sessions ( day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquim Brasil-Neto, University of Brasilia
- Investigators
- Joaquim P Brasil-Neto, PhD, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944501
- Sponsor's protocol ID
- CFSNCC2013
- Other IDs
- CFSNCC2013
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss
- ClinicalTrials.gov ID
- NCT01944501
- Acronym / sponsor ID
- CFSNCC2013
- Conditions
- Tinnitus, Hearing Loss
- Keywords
- tinnitus, hearing loss, Transcranial magnetic stimulation, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Sep 2013 (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.
This study aimed at trying transcranial magnetic stimulation and transcranial direct current stimulation as potential treatments to decrease tinnitus in patients with significant hearing loss.
Detailed description
Tinnitus is a very common condition and affects approximately 15% of the population, disrupting sleep, emotional balance and social life of the patients. Acoustic deprivation causes hearing loss and is responsible for a cascade of processes that result in the reorganization of the cortex through a synchronization of neuronal activity related to a cortical re-mapping. Consistent with the hypothesis that tinnitus is caused by abnormal activation of the auditory cortex, repetitive transcranial magnetic stimulation (rTMS) can temporarily reduce cortical hyperactivity through direct neuromodulation of the temporal cortex. Furthermore, studies have shown that transcranial direct current stimulation (tDCS) can also suppress tinnitus. Objective: To determine the effectiveness of rTMS and TDCS in the treatment of patients with chronic tinnitus and auditory loss. Methods: We performed an analytical experimental double-blind study using rTMS and tDCS in patients with chronic tinnitus and hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Active comparator | Procedure: Transcranial Magnetic StimulationPatients receiving real transcranial magnetic stimulation |
| Sham TMS | Placebo comparator | Procedure: Transcranial Magnetic StimulationPatients receiving sham transcranial magnetic stimulation |
| Transcranial Direct Current Stimulation | Active comparator | Procedure: Transcranial Direct Current StimulationPatients receiving real transcranial direct current stimulation |
| Sham TDCS | Placebo comparator | Procedure: Transcranial Direct Current StimulationPatients receiving sham transcranial direct current stimulation |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic tinnitus
- hearing loss
Key exclusion criteria (4 listed)
- neurological diseases
- use of drugs affecting the central nervous system
- evidence of dementia
- clinical diagnosis of depression
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 |
|---|---|---|
| Transcranial Magnetic StimulationTMS over the left temporoparietal cortex | Procedure or surgery | Sham TMS, Transcranial Magnetic Stimulation |
| Transcranial Direct Current StimulationTDCS over the left temporoparietal cortex | Procedure or surgery | Sham TDCS, Transcranial Direct Current Stimulation |
Primary outcome
Change in Tinnitus Handicap Inventory (THI) scores
Time frame: THI was measured before intervention (baseline) and after 5 daily sessions (day 5)
1 secondary outcome
Change in Visual Analog Scale scores
Time frame: Visual analog scale of tinnitus was recorded at baseline and after daily 5 TMS or TDCS sessions ( day 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
Joaquim P Brasil-Neto, PhD principal investigator
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation in people with Tinnitus and Hearing Loss, run by University of Brasilia at 1 site in Brazil.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Tinnitus Handicap Inventory (THI) scores (time frame: THI was measured before intervention (baseline) and after 5 daily sessions (day 5)). 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 17 Sep 2013.