Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

October 8, 2018 updated by: Seoul National University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active rTMS(A)
low frequency frontal and temporal repetitive transcranial magnetic stimulation
Device: 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.
Experimental: Active rTMS(B)
Temporal low frequency repetitive transcranial magnetic stimulation
Device: 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.
Sham Comparator: Sham condition(C)
low frequency frontal and temporal repetitive transcranial magnetic stimulation
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change from Baseline THI at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.
Time Frame: Change from Baseline VAS at 6 months
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
Baseline, 1, 2 and 3 month after the first intervention
Beck's Depression Inventory (BDI)
Time Frame: Baseline
Baseline
State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline
Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Myung-Whan Suh, MD, ph.D, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-199-08-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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