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

Not Applicable

• Conditions: Otorhinolaryngologic Diseases; Depression; Depressive Disorder; Tinnitus; Hearing Disorders
• Interventions: Device: transcranial electrical stimulation (TES)

• Registration Number: NCT05189587
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-11-24
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-12
• Last Update Submitted: 2022-01-29
• Last Update Posted: 2022-02-01
• Study Start: 2022-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TES group	transcranial electrical stimulation (TES)	Intervention: Device (transcranial electrical stimulation, TES)
sham TES group	transcranial electrical stimulation (TES)	Intervention: Device (transcranial electrical stimulation, TES)

Primary Outcome Measures

Name	Time	Method
Tinnitus handicap inventory (THI)	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.

Secondary Outcome Measures

Name	Time	Method
resting-state quantitative electroencephalography (rs-qEEG)	the same 1 week after treatment	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.