Home-based Transcranial Electrical Stimulation (TES) in Patients With Chronic Tinnitus

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Preliminary Clinical Trial for Efficacy of Non-invasive Home-based Transcranial Electrical Stimulation (TES) Therapy in Patients With Intractable Chronic Tinnitus

Conditions
-----------------
Depression, Depressive Disorder, Hearing Disorders, Otorhinolaryngologic Diseases, Tinnitus

Intervention / Treatment
-----------------
* Device: transcranial electrical stimulation (TES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: psychoactive drug user implanted material pacemaker user

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TES group<br>Intervention: Device (transcranial electrical stimulation, TES) | Device: transcranial electrical stimulation (TES)<br>* 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).<br>|
| Sham Comparator: sham TES group<br>Intervention: Device (transcranial electrical stimulation, TES) | Device: transcranial electrical stimulation (TES)<br>* 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).<br>|
| No Intervention: Control group<br>Intervention: none | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | the same 1 week after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | the same 1 week after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial electrical stimulation, Tinnitus