TinnitusNCT05189587
Home-based Transcranial Electrical Stimulation (TES) in Patients With Chronic Tinnitus
A study testing transcranial electrical stimulation (TES) in people with Tinnitus and Depression, run by Seoul National University Hospital.
Trial summary
The investigators applied home-based transcranial electrical stimulation (TES) for neuromodulative treatment in patients with intractable chronic tinnitus. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Tinnitus, Depression, Depressive Disorder
- What is being tested?
- transcranial electrical stimulation (TES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 30 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Research volunteers with intractable chronic tinnitus 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Preliminary Clinical Trial for Efficacy of Non-invasive Home-based Transcranial Electrical Stimulation (TES) Therapy in Patients With Intractable Chronic Tinnitus
The investigators applied home-based transcranial electrical stimulation (TES) for neuromodulative treatment in patients with intractable chronic tinnitus.
Read the detailed description
For treatment of motor and psychiatric disorders, transcranial electrical stimulation including transcranial direct current stimulation (tDCS), transcranial magnetic stimulation (TMS), or transcranial random noise stimulation (tRNS) are in use worldwidely. The investigators applied these neuromodulation techniques into patients with intractable chronic tinnitus for symptom relief. Experimental groups with 60 subjective tinnitus subjects will be consisted of three different treatment groups which are: TES group, TES with sham stimulation group, and control group. Subjects will be given 1.0 milliampere (mA) TES on bifrontal areas for neuromodulation.
- Conditions
- Tinnitus, Depression, Depressive Disorder, Hearing Disorders, Otorhinolaryngologic Diseases
- Being tested
- transcranial electrical stimulation (TES)
- Keywords
- Transcranial electrical stimulation, Tinnitus
- Medical subject headings
- Tinnitus, Depression, Depressive Disorder, Hearing Disorders, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electrical stimulation (TES)Device
Transcranial electrical stimulation (tES) is a noninvasive brain stimulation technique that passes an electrical current through the cortex of the brain to alter brain function. The electrical current is applied to an individual's scalp usually via two or more electrodes, and whilst a large amount of the current is conducted between electrodes through soft tissue and skull (Vöröslakos et al. 2018), a portion of the current penetrates the scalp and is conducted through the brain, where it can alter neuronal excitability. By altering the activity of brain regions involved with a behaviour of interest, investigators can observe the resulting behavioral changes and so establish a causal link between the two (Reed et al. 2018).
| Study group | Role | What they receive |
|---|---|---|
| TES group | Experimental | Intervention: Device (transcranial electrical stimulation, TES) Receives: Device: transcranial electrical stimulation (TES) |
| sham TES group | Sham comparator | Intervention: Device (transcranial electrical stimulation, TES) Receives: Device: transcranial electrical stimulation (TES) |
| Control group | No intervention | Intervention: none |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus handicap inventory (THI)
The THI consists of 25 items, each with the 3 response options-yes (4 points), sometimes (2 points), and no (0 points)-resulting in a total score range from 0 to 100. A higher score denotes a higher tinnitus-related handicap.
Measured: the same 1 week after treatment
Secondary outcomes (1)
resting-state quantitative electroencephalography (rs-qEEG)
EEG activities in certain cortical regions within all 8 frequency bands will be compared. Specifically, as for the source localization analysis, standardized low-resolution brain electromagnetic tomography (sLORETA) will be employed to estimate the scalp-recorded electrical activity in each of the eight frequency bands (i.e., intracerebral sources). We will identify the cortical sources that generate the activities recorded by the scalp electrodes in each of the following eight frequency bands: delta (2-3.5Hz), theta (4-7.5Hz), alpha 1 (8-10Hz), alpha 2 (10-12Hz), beta 1 (13-18Hz), beta 2 (18.5-21Hz), beta 3 (21.5-30Hz), and gamma (30.5-44Hz). sLORETA computes neuronal electrical activity as current density (A/m2) without assuming a predefined number of active sources.
Measured: the same 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 participants (estimated)
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
- NCT05189587
- Sponsor's protocol ID
- SNUBH_ENT_TES
- Status last verified
- Jan 2022
- First submitted
- 24 Nov 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bae EB, Lee JH, Song JJ. Single-Session of Combined tDCS-TMS May Increase Therapeutic Effects in Subjects With Tinnitus. Front Neurol. 2020 Mar 27;11:160. doi: 10.3389/fneur.2020.00160. eCollection 2020.
PubMed 32292383
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Clinical Trial for Efficacy of Non-invasive Home-based Transcranial Electrical Stimulation (TES) Therapy in Patients With Intractable Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT05189587
- Acronym / sponsor ID
- SNUBH_ENT_TES
- Conditions
- Tinnitus, Depression, Depressive Disorder, Hearing Disorders, Otorhinolaryngologic Diseases
- Keywords
- Transcranial electrical stimulation, Tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 12 Jan 2022 (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 applied home-based transcranial electrical stimulation (TES) for neuromodulative treatment in patients with intractable chronic tinnitus.
Detailed description
For treatment of motor and psychiatric disorders, transcranial electrical stimulation including transcranial direct current stimulation (tDCS), transcranial magnetic stimulation (TMS), or transcranial random noise stimulation (tRNS) are in use worldwidely. The investigators applied these neuromodulation techniques into patients with intractable chronic tinnitus for symptom relief. Experimental groups with 60 subjective tinnitus subjects will be consisted of three different treatment groups which are: TES group, TES with sham stimulation group, and control group. Subjects will be given 1.0 milliampere (mA) TES on bifrontal areas for neuromodulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TES group | Experimental | Device: transcranial electrical stimulation (TES)Intervention: Device (transcranial electrical stimulation, TES) |
| sham TES group | Sham comparator | Device: transcranial electrical stimulation (TES)Intervention: Device (transcranial electrical stimulation, TES) |
| Control group | No intervention | –Intervention: none |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Research volunteers with intractable chronic tinnitus 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 electrical stimulation (TES)Transcranial electrical stimulation (tES) is a noninvasive brain stimulation technique that passes an electrical current through the cortex of the brain to alter brain function. The electrical current is applied to an individual's scalp usually via two or more electrodes, and whilst a large amount of the current is conducted between electrodes through soft tissue and skull (Vöröslakos et al. 2018), a portion of the current penetrates the scalp and is conducted through the brain, where it can alter neuronal excitability. By altering the activity of brain regions involved with a behaviour of interest, investigators can observe the resulting behavioral changes and so establish a causal link between the two (Reed et al. 2018). | Device | TES group, sham TES group |
Primary outcome
Tinnitus handicap inventory (THI)
Time frame: the same 1 week after treatment
The THI consists of 25 items, each with the 3 response options-yes (4 points), sometimes (2 points), and no (0 points)-resulting in a total score range from 0 to 100. A higher score denotes a higher tinnitus-related handicap.
1 secondary outcome
resting-state quantitative electroencephalography (rs-qEEG)
Time frame: the same 1 week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Background: PubMed 32292383Bae EB, Lee JH, Song JJ. Single-Session of Combined tDCS-TMS May Increase Therapeutic Effects in Subjects With Tinnitus. Front Neurol. 2020 Mar 27;11:160. doi: 10.3389/fneur.2020.00160. eCollection 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.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial electrical stimulation (TES) 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Jin Song, Professor (+82-31-787-7408, jjsong96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus handicap inventory (THI) (time frame: the same 1 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05189587, which also lists 1 linked publication.
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 1 Feb 2022.