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

NCT ID: NCT05189587

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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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

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Tinnitus Depression Depressive Disorder Hearing Disorders Otorhinolaryngologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TES group

Intervention: Device (transcranial electrical stimulation, TES)

Group Type EXPERIMENTAL

transcranial electrical stimulation (TES)

Intervention Type 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).

sham TES group

Intervention: Device (transcranial electrical stimulation, TES)

Group Type SHAM_COMPARATOR

transcranial electrical stimulation (TES)

Intervention Type 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).

Control group

Intervention: none

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Jin Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jae-Jin Song, Professor

Role: CONTACT

+82-31-787-7408

References

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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.

Reference Type BACKGROUND
PMID: 32292383 (View on PubMed)

Other Identifiers

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SNUBH_ENT_TES

Identifier Type: -

Identifier Source: org_study_id

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