Verify the Effectiveness rTMS Using MEG (rTMS)

November 18, 2014 updated by: Seoul National University Hospital
The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus

Study Overview

Status

Unknown

Conditions

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)

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active rTMS1
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .
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
Experimental: Active rTMS2
Temporal low frequency rTMS of left primary auditory cortex.

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.

Experimental: Active rTMS3
Frontal low frequency rTMS of left dorsolateral prefrontal cortex .

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.

Sham Comparator: Sham rTMS4
sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in MEG Asymmetry Index and amplitude of the auditory area
Time Frame: Baseline, After active treatment week
Baseline, After active treatment week

Secondary Outcome Measures

Outcome Measure
Time Frame
State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Tinnitus Handicap Inventory (THI)
Time Frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Visual Analog Scales (VAS)
Time Frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Beck Depression Inventory (BDI)
Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Myung-Whan Suh, MD, ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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