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Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus (rTMS)

Primary Purpose

Tinnitus

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Active rTMS 1
Active rTMS 2
Active rTMS 3
sham condition
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

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 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Active rTMS1

Active rTMS2

Active rTMS3

Sham Condition

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 repetitive transcranial magnetic stimulation of left primary auditory cortex

Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex

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

Outcomes

Primary Outcome Measures

Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

Secondary Outcome Measures

Beck's Depression Inventory (BDI)
State-Trait Anxiety Inventory (STAI)
Pittsburgh Sleep Quality Index (PSQI)
visual analogue scale (VAS)

Full Information

First Posted
June 4, 2013
Last Updated
October 8, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01886092
Brief Title
Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
Acronym
rTMS
Official Title
Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
October 2020 (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
Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.

6. Conditions and Keywords

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

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 rTMS1
Arm Type
Active Comparator
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
Active Comparator
Arm Description
Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex
Arm Title
Active rTMS3
Arm Type
Active Comparator
Arm Description
Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex
Arm Title
Sham Condition
Arm Type
Sham Comparator
Arm Description
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
Active rTMS 1
Intervention Description
repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).
Intervention Type
Device
Intervention Name(s)
Active rTMS 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. (20 subjects)
Intervention Type
Device
Intervention Name(s)
Active rTMS 3
Intervention Description
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)
Intervention Type
Device
Intervention Name(s)
sham condition
Intervention Description
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)
Primary Outcome Measure Information:
Title
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time Frame
Change from Baseline inTinnitus Handicap Inventory at 3 months
Secondary Outcome Measure Information:
Title
Beck's Depression Inventory (BDI)
Time Frame
Baseline, before and after each intervention, 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
visual analogue scale (VAS)
Time Frame
Baseline, day 7, day 14, 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 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

Citations:
PubMed Identifier
32944806
Citation
Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Suh MW. Dual-site rTMS is More Effective than Single-site rTMS in Tinnitus Patients: A Blinded Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):767-775. doi: 10.1007/s10548-020-00797-y. Epub 2020 Sep 17.
Results Reference
derived
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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Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

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