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

Seoul National University

Status: Unknown

Conditions: Tinnitus

Treatments: Device: Active rTMS(A); Device: Sham condition(C); Device: Active rTMS(B)

Study type: Interventional

Funder types: Other

Identifiers

NCT02617953

A-199-08-14

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 3 patient groups

Active rTMS(A)

Experimental group

Description:

low frequency frontal and temporal repetitive transcranial magnetic stimulation

Treatment:

Device: Active rTMS(A)

Active rTMS(B)

Experimental group

Description:

Temporal low frequency repetitive transcranial magnetic stimulation

Treatment:

Device: Active rTMS(B)

Sham condition(C)

Sham Comparator group

Description:

low frequency frontal and temporal repetitive transcranial magnetic stimulation

Treatment:

Device: Sham condition(C)