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Status unknownNCT01874444rTMSUpdated Nov 19, 2014

Verify the Effectiveness rTMS Using MEG

An interventional study of 1 and 2 in Tinnitus, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-11-19.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

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)

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Conditions studied

  • Tinnitus

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03

In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's planned enrollment of 28 is below the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • Concomitant medication with antidepressants and antipsychotics
  • Pregnant women
  • Severe depression
  • Severe anxiety
  • Others known contraindications to rTMS or brain MRI
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Active rTMS1

    Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .

    Device: 1

  • Experimental
    Active rTMS2

    Temporal low frequency rTMS of left primary auditory cortex.

    Device: 2

  • Experimental
    Active rTMS3

    Frontal low frequency rTMS of left dorsolateral prefrontal cortex .

    Device: 3

  • Sham comparator
    Sham rTMS4

    sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.

    Device: 4

Interventions

  • Device1

    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

  • Device2

    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.

  • Device3

    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.

  • Device4

    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.

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What researchers measure

Primary outcomes

  1. Change in MEG Asymmetry Index and amplitude of the auditory area

    Time frame: Baseline, After active treatment week

Secondary outcomes

  1. Tinnitus Handicap Inventory (THI)

    Time frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention

  2. Visual Analog Scales (VAS)

    Time frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention

  3. State-Trait Anxiety Inventory (STAI)

    Time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

  5. Beck Depression Inventory (BDI)

    Time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01874444
Lead sponsor
Seoul National University Hospital
Responsible party
Sponsor
First posted
Jun 11, 2013
Start date
May 2013
Primary completion
Nov 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Nov 19, 2014

Study contacts

Myung-Whan Suh, MD, ph.D
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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