TinnitusNCT02617953
Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
A study testing Active rTMS(A) and Active rTMS(B) in people with Tinnitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigation of objective tinnitus diagnosis method through measurement of continuous resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment of tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Active rTMS(A) and Active rTMS(B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Sep 2021
- 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
- Diagnosis of chronic tinnitus
- Chronic subjective tinnitus for more than 6 months
- Subject is naive regarding rTMS
- Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study
- Stable enough to complete this study per the opinion of the Study Physician
- No restrictions, provided the dosages have been in place for at least 3 months
- A three month washout from any other tinnitus treatment or management program is required prior to entering this study.
Who cannot join
- Objective tinnitus or tinnitus with treatable cause
- Presence of intracranial or intraocular ferromagnetic materiel or particles
- Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition
- Personal history of central nervous system disorder, head injury, stroke or seizures
- Familial history of epilepsy
- Concomitant medication with antidepressants and antipsychotics
- Pregnant women
- Others known contraindications to rTMS or brain MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variable Changes in Continuous Resting EEG(Electroencephalography) and Auditory ERP(Event-related Potential) Before and After Transcranial Magnetic Stimulation Treatment; Double Blind Randomized Controll Trails
Investigation of objective tinnitus diagnosis method through measurement of continuous resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment of tinnitus.
Read the detailed description
Tinnitus is defined as the subjective perception of a sound in the absence of any physical sound. Therefore, accurate diagnosis of tinnitus is so difficult.
So, Investigators measure auditory ERP through autonomously developed system to make a objective diagnosis tinnitus. Moreover, patients undergo continuous resting EEG measurement.
In this study investigators examined the efficacy of rTMS treatment for tinnitus and check into changes in brain connectivity or auditory task with ERP, continuous resting EEG before and after rTMS. And develop a new test that can detect tinnitus objectively in humans, using the prepulse gap paradigm
- Conditions
- Tinnitus
- Being tested
- Active rTMS(A), Active rTMS(B), Sham condition(C)
- Keywords
- Tinnitus, EEG, ERP
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMS(A)Device
repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment.
auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.
Active rTMS(B)Device
repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment.
auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.
Sham condition(C)Device
The sham stimulation looks and sounds like the active coil, but diverts the magnetic field away from the patient.
auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS(A) | Experimental | low frequency frontal and temporal repetitive transcranial magnetic stimulation Receives: Device: Active rTMS(A) |
| Active rTMS(B) | Experimental | Temporal low frequency repetitive transcranial magnetic stimulation Receives: Device: Active rTMS(B) |
| Sham condition(C) | Sham comparator | low frequency frontal and temporal repetitive transcranial magnetic stimulation Receives: Device: Sham condition(C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment.
Measured: Change from Baseline THI at 6 months
Secondary outcomes (5)
Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.
Measured: Change from Baseline VAS at 6 months
Positive And Negative Affect Schedule(PANAS)
Measured: Baseline, 1, 2 and 3 month after the first intervention
Beck's Depression Inventory (BDI)
Measured: Baseline
State-Trait Anxiety Inventory (STAI)
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
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 Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myung-Whan Suh, MD, ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617953
- Sponsor's protocol ID
- A-199-08-14
- Status last verified
- Oct 2018
- First submitted
- 28 Oct 2015
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Changes in Continuous Resting EEG(Electroencephalography) and Auditory ERP(Event-related Potential) Before and After Transcranial Magnetic Stimulation Treatment; Double Blind Randomized Controll Trails
- ClinicalTrials.gov ID
- NCT02617953
- Acronym / sponsor ID
- A-199-08-14
- Conditions
- Tinnitus
- Keywords
- Tinnitus, EEG, ERP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 1 Dec 2015 (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.
Investigation of objective tinnitus diagnosis method through measurement of continuous resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment of tinnitus.
Detailed description
Tinnitus is defined as the subjective perception of a sound in the absence of any physical sound. Therefore, accurate diagnosis of tinnitus is so difficult.
So, Investigators measure auditory ERP through autonomously developed system to make a objective diagnosis tinnitus. Moreover, patients undergo continuous resting EEG measurement.
In this study investigators examined the efficacy of rTMS treatment for tinnitus and check into changes in brain connectivity or auditory task with ERP, continuous resting EEG before and after rTMS. And develop a new test that can detect tinnitus objectively in humans, using the prepulse gap paradigm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active rTMS(A) | Experimental | Device: Active rTMS(A)low frequency frontal and temporal repetitive transcranial magnetic stimulation |
| Active rTMS(B) | Experimental | Device: Active rTMS(B)Temporal low frequency repetitive transcranial magnetic stimulation |
| Sham condition(C) | Sham comparator | Device: Sham condition(C)low frequency frontal and temporal repetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of chronic tinnitus
- Chronic subjective tinnitus for more than 6 months
- Subject is naive regarding rTMS
- Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study
- Stable enough to complete this study per the opinion of the Study Physician
Key exclusion criteria (8 listed)
- Objective tinnitus or tinnitus with treatable cause
- Presence of intracranial or intraocular ferromagnetic materiel or particles
- Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition
- Personal history of central nervous system disorder, head injury, stroke or seizures
- Familial history of epilepsy
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 |
|---|---|---|
| Active rTMS(A)repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train. | Device | Active rTMS(A) |
| Active rTMS(B)repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train. | Device | Active rTMS(B) |
| Sham condition(C)The sham stimulation looks and sounds like the active coil, but diverts the magnetic field away from the patient. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train. | Device | Sham condition(C) |
Primary outcome
Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment.
Time frame: Change from Baseline THI at 6 months
5 secondary outcomes
Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.
Time frame: Change from Baseline VAS at 6 months
Positive And Negative Affect Schedule(PANAS)
Time frame: Baseline, 1, 2 and 3 month after the first intervention
Beck's Depression Inventory (BDI)
Time frame: Baseline
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- 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.
Myung-Whan Suh, MD, ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS(A) and Active rTMS(B) in people with Tinnitus, run by Seoul National University Hospital at 1 site in South Korea.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. 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 South Korea. 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?
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?
Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment. (time frame: Change from Baseline THI at 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 9 Oct 2018.