TinnitusrTMSNCT01874444
Verify the Effectiveness rTMS Using MEG
A study testing 1, 2 and 3 in people with Tinnitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether rTMS are effective in 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?
- 1, 2 and 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Dec 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
- Diagnosis of chronic tinnitus
- Chronic subjective tinnitus for more than 6 months
- Pure tone average <50 dB HL in the ear where tinnitus is perceived
- Dominant tinnitus frequency measured between 4 and 8 kHz
- Subject is naive regarding rTMS
- Other concurrent treatments: A four-week washout from any other tinnitus
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- 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
- Absolute thresholds > 60 dB on individual frequencies up to 8 kHz
- 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;
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- Concomitant medication with antidepressants and antipsychotics
- Pregnant women
- Severe depression
- Severe anxiety
- Others known contraindications to rTMS or brain MRI
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. We aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness. Linked to a neuronavigation system that is guided by magnetic resonance imaging (MRI) of the frontal and temporal, rTMS can suppress areas of cortical plasticity. This cortical reorganization can be demonstrated by magnetoencephalography (MEG)
- Conditions
- Tinnitus
- Being tested
- 1, 2, 3, 4
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1Device
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 1000 stimuli of 1Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of 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.
Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.
3Device
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left frontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment.
Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.
4Device
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.
Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS1 | Experimental | Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex . Receives: Device: 1 |
| Active rTMS2 | Experimental | Temporal low frequency rTMS of left primary auditory cortex. Receives: Device: 2 |
| Active rTMS3 | Experimental | Frontal low frequency rTMS of left dorsolateral prefrontal cortex . Receives: Device: 3 |
| Sham rTMS4 | Sham comparator | sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. Receives: Device: 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MEG Asymmetry Index and amplitude of the auditory area
Measured: Baseline, After active treatment week
Secondary outcomes (5)
Tinnitus Handicap Inventory (THI)
Measured: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Visual Analog Scales (VAS)
Measured: Baseline, day 3, day 7, day 14, 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
Beck Depression Inventory (BDI)
Measured: Baseline, before and after each intervention, 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 posted11 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 28 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
- NCT01874444
- Sponsor's protocol ID
- TN2447
- Acronym
- rTMS
- Status last verified
- Dec 2013
- First submitted
- 4 Jun 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Noh 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 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verify the Effectiveness rTMS Using MEG
- ClinicalTrials.gov ID
- NCT01874444
- Acronym / sponsor ID
- rTMS / TN2447
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 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.
The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. We aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness. Linked to a neuronavigation system that is guided by magnetic resonance imaging (MRI) of the frontal and temporal, rTMS can suppress areas of cortical plasticity. This cortical reorganization can be demonstrated by magnetoencephalography (MEG)
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 | Experimental | Device: 1Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex . |
| Active rTMS2 | Experimental | Device: 2Temporal low frequency rTMS of left primary auditory cortex. |
| Active rTMS3 | Experimental | Device: 3Frontal low frequency rTMS of left dorsolateral prefrontal cortex . |
| Sham rTMS4 | Sham comparator | Device: 4sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of chronic tinnitus
- Chronic subjective tinnitus for more than 6 months
- Pure tone average <50 dB HL in the ear where tinnitus is perceived
- Dominant tinnitus frequency measured between 4 and 8 kHz
- Subject is naive regarding rTMS
Key exclusion criteria (11 listed)
- Objective tinnitus or tinnitus with treatable cause
- Absolute thresholds > 60 dB on individual frequencies up to 8 kHz
- 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
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 |
|---|---|---|
| 1repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 1000 stimuli of 1Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS | Device | Active rTMS1 |
| 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. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS. | Device | Active rTMS2 |
| 3repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left frontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS. | Device | Active rTMS3 |
| 4Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS. | Device | Sham rTMS4 |
Primary outcome
Change in MEG Asymmetry Index and amplitude of the auditory area
Time frame: Baseline, After active treatment week
5 secondary outcomes
Tinnitus Handicap Inventory (THI)
Time frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Visual Analog Scales (VAS)
Time frame: Baseline, day 3, day 7, day 14, 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
Beck Depression Inventory (BDI)
Time frame: Baseline, before and after each intervention, 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 19 Nov 2014.
- 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 1, 2 and 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 10 inclusion and 11 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 19 Nov 2014. 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 in MEG Asymmetry Index and amplitude of the auditory area (time frame: Baseline, After active treatment week). 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 NCT01874444, which also lists 1 linked publication.
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 19 Nov 2014.