An interventional study of Transcranial direct current stimulation in Tinnitus, Subjective, sponsored by Dongtan Sacred Heart Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Dongtan Sacred Heart Hospital · Not applicable, Interventional, and Treatment
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.
The participants were randomly allocated with three different arms (control, single-session, and dual session) using block to balance the size of each group. Pure tone audiometry, speech audiometry, tinnitogram (pitch matching, loudness, minimal masking level and residual inhibition), auditory evoked potential, THI, visual analogue scale (VAS) of loudness, awareness and annoyance, and BDI were evaluated as a baseline tests. Participants who assigned to the control group underwent dual sham stimulation per day, twice a week for 1 month. Patients were received sham and true stimulation once alternately in the single session group and two true stimulation per day in the dual session group for the same period as the control group. All subjects who enrolled this study were given a conventional treatment such as tinnitus retraining therapy, sound therapy using sound generator, and medications like clonazepam, selective serotonin reuptake inhibitors for patients who wanted to take for relief of symptoms.
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 339 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Dongtan Sacred Heart Hospital is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The subjects in control group were received two consecutive sessions of sham stimulation twice a week for 4 weeks (8 sessions in total).
Device: Transcranial direct current stimulation
Patients enrolled to the single-session group received tDCS on one random session out of two consecutive sessions.
Device: Transcranial direct current stimulation
In the dual-session group, the patients underwent two consecutives tDCS.
Device: Transcranial direct current stimulation
The device used for tDCS in this study was DC-Stimulator Plus (NeuroConn GmbH, Ilmenau, Germany). The localization of stimulation area (DLPFC) was determined according to the 10/20 EEG system. Non-conducting, elastic head strap was placed around the head to prevent displacement during stimulation. The recording electrode covered with 5 x 7 cm sized traditional rectangular sponge was soaked with 6-7 mL of 0.9% NaCl saline solution per side and placed on the F3 (anode, left frontal) and F4 (cathode, right frontal) EEG location. Subjects were given 2 mA stimulation intensity for 20 min per session including fade-in and fade-out times for 20 seconds each. Interval between each session was 20 min. Sham procedure has been adopted a Fade In of current, Short Stimulation, Fade Out (FISSFO) protocol that consist of initial ramp up for 20 seconds, 2 mA stimulation for 40 seconds, and 20 seconds for ramp down. To check to impendence, brief current of 110 µA over 15ms every 550ms was delivered.
Visual analogue scale (VAS) related to tinnitus
To achieve a more quantitative evaluation of tinnitus reduction, we assessed the Visual Analog Scale (VAS).
Time frame: 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)
The subjective improvement of tinnitus was evaluated using THI.
Time frame: THI was assessed at the 4th and 8th week visits.
Beck depression inventory (BDI)
To assess the association between tinnitus relief and depression, we evaluated the Beck Depression Inventory (BDI).
Time frame: THI was assessed at the 4th and 8th week visits.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Dongtan Sacred Heart Hospital