TinnitusNCT04262050
Combined tDCS and TMS on Subjective Tinnitus and Combined Depression
A study testing transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) in people with Tinnitus and Depression, run by Seoul National University Hospital.
Trial summary
The investigators combined transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) to increase the effective response of a single session of neuromodulation in subjective tinnitus. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Depression
- What is being tested?
- transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Jul 2018
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital
Who cannot join
- psychoactive drug user
- implanted material
- pacemaker user
About this study
Official title: The Effect of Combination Transcranial Direct Current Stimulation and Transcranial Magnetic Stimulation on Subjective Tinnitus and Combined Depression
The investigators combined transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) to increase the effective response of a single session of neuromodulation in subjective tinnitus.
Read the detailed description
To treat motor and psychiatric disorders, transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are world-widely in use in clinics. The investigators combined these two types of neuromodulation techniques to increase the effective response of a single session of neuromodulation in subjective tinnitus. Experimental groups with 80 tinnitus subjects consisted of four different treatment groups which are tDCS, tDCS with sham TMS, tDCS-TMS and TMS group. Subjects were given 1.5milliampere (mA) tDCS on the bi-frontal area and TMS stimulated contralateral single side of the temporoparietal cortex with 200 pulses at 1herz (Hz) stimulation.
- Conditions
- Tinnitus, Depression
- Being tested
- transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)
- Keywords
- Tinnitus, tDCS, TMS
- Medical subject headings
- Tinnitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)Device
| Study group | Role | What they receive |
|---|---|---|
| TMS + tDCS group | Experimental | Not described Receives: Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) |
| sham TMS + tDCS group | Experimental | Not described Receives: Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) |
| tDCS group | Experimental | Not described Receives: Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) |
| TMS group | Experimental | Not described Receives: Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus handicap inventory
tinnitus-related questionnaire
Measured: the same 1 day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Aug 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Jin Song, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262050
- Sponsor's protocol ID
- B-1607/355-004
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combination Transcranial Direct Current Stimulation and Transcranial Magnetic Stimulation on Subjective Tinnitus and Combined Depression
- ClinicalTrials.gov ID
- NCT04262050
- Acronym / sponsor ID
- B-1607/355-004
- Conditions
- Tinnitus, Depression
- Keywords
- Tinnitus, tDCS, TMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 10 Feb 2020 (actual)
- 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 investigators combined transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) to increase the effective response of a single session of neuromodulation in subjective tinnitus.
Detailed description
To treat motor and psychiatric disorders, transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are world-widely in use in clinics. The investigators combined these two types of neuromodulation techniques to increase the effective response of a single session of neuromodulation in subjective tinnitus. Experimental groups with 80 tinnitus subjects consisted of four different treatment groups which are tDCS, tDCS with sham TMS, tDCS-TMS and TMS group. Subjects were given 1.5milliampere (mA) tDCS on the bi-frontal area and TMS stimulated contralateral single side of the temporoparietal cortex with 200 pulses at 1herz (Hz) stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TMS + tDCS group | Experimental | Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) |
| sham TMS + tDCS group | Experimental | Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) |
| tDCS group | Experimental | Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) |
| TMS group | Experimental | Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital
Key exclusion criteria (3 listed)
- psychoactive drug user
- implanted material
- pacemaker user
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) | Device | TMS + tDCS group, TMS group, sham TMS + tDCS group, tDCS group |
Primary outcome
Tinnitus handicap inventory
Time frame: the same 1 day after treatment
tinnitus-related questionnaire
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 10 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) in people with Tinnitus and Depression, run by Seoul National University Hospital.
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 1 inclusion and 3 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 (time frame: the same 1 day after treatment). 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 10 Feb 2020.