CompletedNot Applicable

Consecutive Dual-Session tDCS in Chronic Subjective Severe to Catastrophic Tinnitus With Normal Hearing

South Korea42 participantsStarted 2021-12-15

Plain-language summary

We aimed to analyze the effect of continuous dual session tDCS in patients with severe chronic subjective tinnitus without any evidence of hearing loss in terms of relief of tinnitus perception, distress, and loudness. Also, we investigated the difference in the maintenance duration of the tinnitus suppression effect of consecutive dual session tDCS compared to other groups followed up for 2 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals who have experienced subjective tinnitus for over 3 months. * Individuals with normal hearing, defined as an average pure tone threshold of less than 25 dB between 0.5-4 kHz, and the presence of the V wave at 30 dBnHL with a difference in V wave latency of less than 0.2 ms in both ears during the ABR test. * Individuals with severe tinnitus, as indicated by a Tinnitus Handicap Inventory (THI) score of 58 or higher, and who have been assessed for symptoms of anxiety and depressive mood using the Beck Depression Inventory (BDI) questionnaire. Exclusion Criteria: * Those requiring treatment for neurological disorders such as epilepsy, migraine, or intracranial masses. * Pregnant individuals on the day of providing consent and those with metal-based electric implantable prosthetics. * Individuals with objective or somatic tinnitus, auditory hallucinations, unwillingness to provide written consent, or unwillingness to continue the trial, and those who have participated in previous trials involving tDCS for tinnitus.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual analogue scale (VAS) related to tinnitus

Timeframe: All participants were checked the VAS immediately after the last stimulation of every week for 4 weeks and 8th week (4 weeks after the end of treatment).

Tinnitus Handicap Inventory (THI)

Timeframe: THI was assessed at the 4th and 8th week visits.

Beck depression inventory (BDI)

Timeframe: THI was assessed at the 4th and 8th week visits.

Trial details

NCT IDNCT06423742

SponsorDongtan Sacred Heart Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Tinnitus, Subjective trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Visual analogue scale (VAS) related to tinnitus

Timeframe: All participants were checked the VAS immediately after the last stimulation of every week for 4 weeks and 8th week (4 weeks after the end of treatment).

Tinnitus Handicap Inventory (THI)

Timeframe: THI was assessed at the 4th and 8th week visits.

Beck depression inventory (BDI)

Timeframe: THI was assessed at the 4th and 8th week visits.