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

Primary Purpose

Tinnitus

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Active rTMS(A)
Active rTMS(B)
Sham condition(C)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, EEG, ERP

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Active rTMS(A)

Active rTMS(B)

Sham condition(C)

Arm Description

low frequency frontal and temporal repetitive transcranial magnetic stimulation

Temporal low frequency repetitive transcranial magnetic stimulation

low frequency frontal and temporal repetitive transcranial magnetic stimulation

Outcomes

Primary Outcome Measures

Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment.

Secondary Outcome Measures

Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.
Positive And Negative Affect Schedule(PANAS)
Beck's Depression Inventory (BDI)
State-Trait Anxiety Inventory (STAI)
Pittsburgh Sleep Quality Index (PSQI)

Full Information

First Posted
October 28, 2015
Last Updated
October 8, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02617953
Brief Title
Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, EEG, ERP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS(A)
Arm Type
Experimental
Arm Description
low frequency frontal and temporal repetitive transcranial magnetic stimulation
Arm Title
Active rTMS(B)
Arm Type
Experimental
Arm Description
Temporal low frequency repetitive transcranial magnetic stimulation
Arm Title
Sham condition(C)
Arm Type
Sham Comparator
Arm Description
low frequency frontal and temporal repetitive transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
Active rTMS(A)
Intervention Description
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
Intervention Name(s)
Active rTMS(B)
Intervention Description
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
Intervention Name(s)
Sham condition(C)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.
Time Frame
Change from Baseline VAS at 6 months
Title
Positive And Negative Affect Schedule(PANAS)
Time Frame
Baseline, 1, 2 and 3 month after the first intervention
Title
Beck's Depression Inventory (BDI)
Time Frame
Baseline
Title
State-Trait Anxiety Inventory (STAI)
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung-Whan Suh, MD, ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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