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The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients

A

Antwerp University Hospital (UZA)

Status

Completed

Conditions

Tinnitus

Treatments

Device: transcranial direct current stimulation (tDCS)

Study type

Interventional

Funder types

Other

Identifiers

NCT02285803
EC 14/40/406

Details and patient eligibility

About

The aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire and psychoacoustic measurements.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Duration of tinnitus > 6 months
  • Maximum loudness of tinnitus on the VAS ≥ 4
  • TFI score ≥ 25

Exclusion criteria

  • Pregnancy
  • Psychiatric disorders
  • Pace maker or defibrillator
  • Pulsatile tinnitus
  • Acoustic Neurinoma
  • CVA

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

TRT and real tDCS
Active Comparator group
Treatment:
Device: transcranial direct current stimulation (tDCS)
TRT and sham tDCS
Sham Comparator group
Treatment:
Device: transcranial direct current stimulation (tDCS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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