A Preliminary Clinical Trial for Efficacy of Non-invasive Home-based Transcranial Electrical Stimulation (TES) Therapy in Patients With Intractable Chronic Tinnitus
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tinnitus
- Sponsor
- Seoul National University Hospital
- Enrollment
- 60
- Primary Endpoint
- Tinnitus handicap inventory (THI)
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jae-Jin Song
Professor
Seoul National University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- resting-state quantitative electroencephalography (rs-qEEG)(the same 1 week after treatment)