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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02617953
• Other study ID #: A-199-08-14
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2021

Study information

• Verified date: October 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment.		Change from Baseline THI at 6 months
Secondary	Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.		Change from Baseline VAS at 6 months
Secondary	Positive And Negative Affect Schedule(PANAS)		Baseline, 1, 2 and 3 month after the first intervention
Secondary	Beck's Depression Inventory (BDI)		Baseline
Secondary	State-Trait Anxiety Inventory (STAI)		Baseline
Secondary	Pittsburgh Sleep Quality Index (PSQI)		Baseline