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Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus

Primary Purpose

Patients With Subjective Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
real repetitive Transcranial Magnetic Stimulation
sham repetitive Transcranial Magnetic Stimulation
Sponsored by
Dongtan Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Subjective Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, and Department of Otorhinolaryngology-Head & Neck Surgery Dongtan Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real rTMS

Sham rTMS

Arm Description

Real rTMS is real continuous theta burst stimulation.

Sham rTMS is sham continuous theta burst stimulation.

Outcomes

Primary Outcome Measures

Tinnitus handicap inventory score
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.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2014
Last Updated
August 17, 2021
Sponsor
Dongtan Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02071732
Brief Title
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus
Official Title
Repetitive Transcranial Magnetic Stimulation (rTMS) Effect on Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongtan Sacred Heart Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Subjective Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real rTMS
Arm Type
Active Comparator
Arm Description
Real rTMS is real continuous theta burst stimulation.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham rTMS is sham continuous theta burst stimulation.
Intervention Type
Device
Intervention Name(s)
real repetitive Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
sham repetitive Transcranial Magnetic Stimulation
Intervention Description
This sham stimulation is not true stimulation.
Primary Outcome Measure Information:
Title
Tinnitus handicap inventory score
Description
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.
Time Frame
Before (- six months) and after (+ 5 days) rTMS interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Neurology, and Department of Otorhinolaryngology-Head & Neck Surgery Dongtan Sacred Heart Hospital
City
Hwaseong-si
State/Province
Gyeonggi-do
ZIP/Postal Code
445-907
Country
Korea, Republic of

12. IPD Sharing Statement

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Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus

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