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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05189587
• Other study ID #: SNUBH_ENT_TES
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2022
• Source: Seoul National University Hospital
• Contact: Jae-Jin Song, Professor
• Phone: +82-31-787-7408
• Email: jjsong96[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators applied home-based transcranial electrical stimulation (TES) for neuromodulative treatment in patients with intractable chronic tinnitus.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Disease
• Hearing Disorders
• Otorhinolaryngologic Diseases
• Tinnitus

Intervention

Device:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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