Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus

August 17, 2021 updated by: Suk Yun Kang, Dongtan Sacred Heart Hospital

Repetitive Transcranial Magnetic Stimulation (rTMS) Effect on Tinnitus

The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of tinnitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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

  • Korea, Republic of
    • Gyeonggi-do
      • Hwaseong-si, Gyeonggi-do, Korea, Republic of, 445-907
        • Department of Neurology, and Department of Otorhinolaryngology-Head & Neck Surgery Dongtan Sacred Heart Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjective tinnitus
  • Age 18 years and older

Exclusion Criteria:

  • Meniere, conductive hearing loss, objective tinnitus
  • History of seizure disorder or epilepsy
  • Clinically relevant psychiatric comorbidity
  • Previous symptomatic stroke
  • Surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real rTMS
Real rTMS is real continuous theta burst stimulation.
Device: real repetitive Transcranial Magnetic Stimulation
Sham Comparator: Sham rTMS
Sham rTMS is sham continuous theta burst stimulation.
Device: sham repetitive Transcranial Magnetic Stimulation
This sham stimulation is not true stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus handicap inventory score
Time Frame: Before (- six months) and after (+ 5 days) rTMS interventions
Primary outcomes will be measured twice. One is before, and the other is after 5-day rTMS interventions. Baseline primary outcome will be acceptable if it is done within the prior 6 months of 1st rTMS. Follow-up primary outcome will be done within the five days after 5th rTMS.
Before (- six months) and after (+ 5 days) rTMS interventions

Collaborators and Investigators

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

Sponsor

Dongtan Sacred Heart Hospital

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

February 1, 2014

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-002 (Other Identifier: Barbara Ann Karmanos Cancer Institute)

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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