NCT02071732

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

7.5 years

First QC Date

February 19, 2014

Last Update Submit

August 17, 2021

Conditions

Patients With Subjective Tinnitus

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before (- six months) and after (+ 5 days) rTMS interventions

Study Arms (2)

Real rTMS

ACTIVE COMPARATOR

Real rTMS is real continuous theta burst stimulation.

Device: real repetitive Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Sham rTMS is sham continuous theta burst stimulation.

Device: sham repetitive Transcranial Magnetic Stimulation

Interventions

real repetitive Transcranial Magnetic StimulationDEVICE
Real rTMS
sham repetitive Transcranial Magnetic StimulationDEVICE

This sham stimulation is not true stimulation.

Sham rTMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjective tinnitus
  • Age 18 years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hwaseong-si, Gyeonggi-do, 445-907, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical professor

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 26, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Locations

KR(1)