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

NCT06423742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-05-21

No results posted yet for this study

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.

Conditions

  • Tinnitus, Subjective

Interventions

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.

Sponsors & Collaborators

  • Dongtan Sacred Heart Hospital

    lead OTHER

Principal Investigators

  • Sung Kyun Kim · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06423742 on ClinicalTrials.gov