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

NCT ID: NCT02617953

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-09-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active rTMS(A)

low frequency frontal and temporal repetitive transcranial magnetic stimulation

Group Type: EXPERIMENTAL

Active rTMS(A)

Intervention Type: 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)

Temporal low frequency repetitive transcranial magnetic stimulation

Group Type: EXPERIMENTAL

Active rTMS(B)

Intervention Type: 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)

low frequency frontal and temporal repetitive transcranial magnetic stimulation

Group Type: SHAM_COMPARATOR

Sham condition(C)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myung-Whan Suh, MD, ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

A-199-08-14

Identifier Type: -

Identifier Source: org_study_id