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

Seoul National University

Status: Unknown

Conditions: Hearing Disorders; Otorhinolaryngologic Diseases; Tinnitus; Depression; Depressive Disorder

Treatments: Device: transcranial electrical stimulation (TES)

Study type: Interventional

Funder types: Other

Identifiers

NCT05189587

SNUBH_ENT_TES

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

TES group

Experimental group

Description:

Intervention: Device (transcranial electrical stimulation, TES)

Treatment:

Device: transcranial electrical stimulation (TES)

sham TES group

Sham Comparator group

Description:

Intervention: Device (transcranial electrical stimulation, TES)

Treatment:

Device: transcranial electrical stimulation (TES)

Control group

No Intervention group

Description:

Intervention: none