Patients With Subjective TinnitusNCT02071732
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus
A study testing real repetitive Transcranial Magnetic Stimulation in people with Patients With Subjective Tinnitus, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Subjective Tinnitus
- What is being tested?
- real repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective tinnitus
- Age 18 years and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Neurology, and Department of Otorhinolaryngology-Head & Neck Surgery Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 445-907
About this study
Official title: 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.
- Conditions
- Patients With Subjective Tinnitus
- Being tested
- real repetitive Transcranial Magnetic Stimulation, sham repetitive Transcranial Magnetic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real repetitive Transcranial Magnetic StimulationDevice
sham repetitive Transcranial Magnetic StimulationDevice
This sham stimulation is not true stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS | Active comparator | Real rTMS is real continuous theta burst stimulation. Receives: Device: real repetitive Transcranial Magnetic Stimulation |
| Sham rTMS | Sham comparator | Sham rTMS is sham continuous theta burst stimulation. Receives: Device: sham repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before (- six months) and after (+ 5 days) rTMS interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Subjective TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongtan Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk Yun Kang, Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071732
- Sponsor's protocol ID
- 2014-002
- Status last verified
- Aug 2021
- First submitted
- 19 Feb 2014
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) Effect on Tinnitus
- ClinicalTrials.gov ID
- NCT02071732
- Acronym / sponsor ID
- 2014-002
- Conditions
- Patients With Subjective Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dongtan Sacred Heart HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of tinnitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real rTMS | Active comparator | Device: real repetitive Transcranial Magnetic StimulationReal rTMS is real continuous theta burst stimulation. |
| Sham rTMS | Sham comparator | Device: sham repetitive Transcranial Magnetic StimulationSham rTMS is sham continuous theta burst stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjective tinnitus
- Age 18 years and older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real repetitive Transcranial Magnetic Stimulation | Device | Real rTMS |
| sham repetitive Transcranial Magnetic StimulationThis sham stimulation is not true stimulation. | Device | Sham rTMS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
Related trials for Patients With Subjective Tinnitus
Not yet recruiting
COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real repetitive Transcranial Magnetic Stimulation in people with Patients With Subjective Tinnitus, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus handicap inventory score (time frame: Before (- six months) and after (+ 5 days) rTMS interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.