TinnitusrTMSNCT01886092
Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
A study testing Active rTMS 1, Active rTMS 2 and Active rTMS 3 in people with Tinnitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Efficacy of different protocols of transcranial magnetic stimulation for the 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 1, Active rTMS 2 and Active rTMS 3
- 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
- May 2013to Oct 2020
- 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: Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus
Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.
- Conditions
- Tinnitus
- Being tested
- Active rTMS 1, Active rTMS 2, Active rTMS 3, sham condition
- Keywords
- tinnitus
- 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 1Device
repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).
Active rTMS 2Device
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects)
Active rTMS 3Device
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)
sham conditionDevice
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS1 | Active comparator | Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex Receives: Device: Active rTMS 1 |
| Active rTMS2 | Active comparator | Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex Receives: Device: Active rTMS 2 |
| Active rTMS3 | Active comparator | Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex Receives: Device: Active rTMS 3 |
| Sham Condition | Sham comparator | Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex Receives: Device: sham condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Measured: Change from Baseline inTinnitus Handicap Inventory at 3 months
Secondary outcomes (4)
Beck's Depression Inventory (BDI)
Measured: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
State-Trait Anxiety Inventory (STAI)
Measured: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
visual analogue scale (VAS)
Measured: Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- NCT01886092
- Sponsor's protocol ID
- H-1212-081-451
- Other IDs
- SNUHT1
- Acronym
- rTMS
- Status last verified
- Oct 2018
- First submitted
- 4 Jun 2013
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Suh MW. Dual-site rTMS is More Effective than Single-site rTMS in Tinnitus Patients: A Blinded Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):767-775. doi: 10.1007/s10548-020-00797-y. Epub 2020 Sep 17.
PubMed 32944806Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Chung CK, Kim JS, Suh MW. Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial. Audiol Neurootol. 2019;24(6):293-298. doi: 10.1159/000503134. Epub 2019 Dec 12.
PubMed 31830753
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
- Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT01886092
- Acronym / sponsor ID
- rTMS / H-1212-081-451
- Conditions
- Tinnitus
- Keywords
- tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 25 Jun 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.
Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active rTMS1 | Active comparator | Device: Active rTMS 1Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex |
| Active rTMS2 | Active comparator | Device: Active rTMS 2Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex |
| Active rTMS3 | Active comparator | Device: Active rTMS 3Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex |
| Sham Condition | Sham comparator | Device: sham conditionCombined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex |
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 1repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects). | Device | Active rTMS1 |
| Active rTMS 2repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects) | Device | Active rTMS2 |
| Active rTMS 3repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects) | Device | Active rTMS3 |
| sham conditionSham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects) | Device | Sham Condition |
Primary outcome
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time frame: Change from Baseline inTinnitus Handicap Inventory at 3 months
4 secondary outcomes
Beck's Depression Inventory (BDI)
Time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
visual analogue scale (VAS)
Time frame: Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention
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.
- Derived from this study: PubMed 32944806Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Suh MW. Dual-site rTMS is More Effective than Single-site rTMS in Tinnitus Patients: A Blinded Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):767-775. doi: 10.1007/s10548-020-00797-y. Epub 2020 Sep 17.
- Derived from this study: PubMed 31830753Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Chung CK, Kim JS, Suh MW. Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial. Audiol Neurootol. 2019;24(6):293-298. doi: 10.1159/000503134. Epub 2019 Dec 12.
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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 1, Active rTMS 2 and Active rTMS 3 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 severity as measured by the Tinnitus Handicap Inventory (THI) (time frame: Change from Baseline inTinnitus Handicap Inventory at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886092, which also lists 2 linked publications.
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.