Verify the Effectiveness rTMS Using MEG (rTMS)
Primary Purpose
Tinnitus
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
1
2
3
4
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
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)
1
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)
2
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)
3
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)
4
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
No
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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