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Verify the Effectiveness rTMS Using MEG (rTMS)

Primary Purpose

Tinnitus

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

About this trial

This is an interventional treatment trial for Tinnitus

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
Pure tone average <50 dB HL in the ear where tinnitus is perceived
Dominant tinnitus frequency measured between 4 and 8 kHz
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
Absolute thresholds > 60 dB on individual frequencies up to 8 kHz
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
Severe depression
Severe anxiety
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 4

Arm Type

Experimental

Sham Comparator

Arm Label

Active rTMS1

Active rTMS2

Active rTMS3

Sham rTMS4

Arm Description

Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .

Temporal low frequency rTMS of left primary auditory cortex.

Frontal low frequency rTMS of left dorsolateral prefrontal cortex .

sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.

Outcomes

Primary Outcome Measures

Change in MEG Asymmetry Index and amplitude of the auditory area

Secondary Outcome Measures

Tinnitus Handicap Inventory (THI)

Visual Analog Scales (VAS)

State-Trait Anxiety Inventory (STAI)

Pittsburgh Sleep Quality Index (PSQI)

Beck Depression Inventory (BDI)

Full Information

NCT ID

NCT01874444

First Posted

June 4, 2013

Last Updated

November 18, 2014

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01874444

Brief Title

Verify the Effectiveness rTMS Using MEG

Acronym

rTMS

Official Title

Verify the Effectiveness rTMS Using MEG

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

November 2015 (Anticipated)

Study Completion Date

December 2015 (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

The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. We aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness. Linked to a neuronavigation system that is guided by magnetic resonance imaging (MRI) of the frontal and temporal, rTMS can suppress areas of cortical plasticity. This cortical reorganization can be demonstrated by magnetoencephalography (MEG)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS1

Arm Type

Experimental

Arm Description

Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .

Arm Title

Active rTMS2

Arm Type

Experimental

Arm Description

Temporal low frequency rTMS of left primary auditory cortex.

Arm Title

Active rTMS3

Arm Type

Experimental

Arm Description

Frontal low frequency rTMS of left dorsolateral prefrontal cortex .

Arm Title

Sham rTMS4

Arm Type

Sham Comparator

Arm Description

sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.

Intervention Type

Device

Intervention Name(s)

Intervention Description

repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 1000 stimuli of 1Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS

Intervention Type

Device

Intervention Name(s)

Intervention Description

repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.

Intervention Type

Device

Intervention Name(s)

Intervention Description

repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left frontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.

Intervention Type

Device

Intervention Name(s)

Intervention Description

Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.

Primary Outcome Measure Information:

Title

Change in MEG Asymmetry Index and amplitude of the auditory area

Time Frame

Baseline, After active treatment week

Secondary Outcome Measure Information:

Title

Tinnitus Handicap Inventory (THI)

Time Frame

Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention

Title

Visual Analog Scales (VAS)

Time Frame

Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention

Title

State-Trait Anxiety Inventory (STAI)

Time Frame

Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

Title

Pittsburgh Sleep Quality Index (PSQI)

Time Frame

Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

Title

Beck Depression Inventory (BDI)

Time Frame

Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of chronic tinnitus Chronic subjective tinnitus for more than 6 months Pure tone average <50 dB HL in the ear where tinnitus is perceived Dominant tinnitus frequency measured between 4 and 8 kHz 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 Absolute thresholds > 60 dB on individual frequencies up to 8 kHz 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 Severe depression Severe anxiety 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

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

31830753

Citation

Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Chung CK, Kim JS, Suh MW. Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial. Audiol Neurootol. 2019;24(6):293-298. doi: 10.1159/000503134. Epub 2019 Dec 12.

Results Reference

derived

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Verify the Effectiveness rTMS Using MEG

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