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Long-term tDCS Tinnitus Treatment

NCT05437185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-06-29

No results posted yet for this study

Summary

The study was designed to evaluate a therapeutic effect of tDCS in the treatment of tinnitus and its comorbidities (anxiety, depresion) and to evaluate the associated quality of life.

In the randomized, double-blinded, sham-controlled trial, 39 participants (active n=19, sham n=20) underwent bilateral dorsolateral prefrontal cortex (DLPFC) tDCS (anode over right DLPFC, cathode left DLPFC, current of 1.5 mA, 20 minutes, 6 sessions in 2 weeks). Tinnitus Functional Index (TFI), Iowa Tinnitus Handicap Questionnaire (ITHQ), Beck Anxiety Inventory (BAI), Zung Self-Rating Depression Scale (SDS), and WHO-Quality of Life-BREF were employed in 4 evaluation points, including the follow-ups of 6 weeks and six months.

Conditions

  • Tinnitus

Interventions

DEVICE

Transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory method utilizing weak electrical currents to elicit short and long-term central nervous system changes.

DEVICE

Sham Transcranial Direct Current Stimulation

The sham was administered using the same tDCS devices as in the active group with a preprogrammed sham protocol of 20 minutes to be virtually indistinguishable from the active stimulation.

Sponsors & Collaborators

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Tadeas Mares, M.D. · Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague

  • Martin Anders, M.D., Ph.D. · Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague

  • Jozef Buday, M.D., Ph.D. · Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • Czechia

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 NCT05437185 on ClinicalTrials.gov