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

January 29, 2022 updated by: Jae-Jin Song, Seoul National University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TES group
Intervention: Device (transcranial electrical stimulation, TES)
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).
SHAM_COMPARATOR: sham TES group
Intervention: Device (transcranial electrical stimulation, TES)
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).
NO_INTERVENTION: Control group
Intervention: none

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting-state quantitative electroencephalography (rs-qEEG)
Time Frame: 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.
the same 1 week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

January 11, 2022

First Posted (ACTUAL)

January 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 29, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_ENT_TES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Disorder

Clinical Trials on transcranial electrical stimulation (TES)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe