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Completed

NCT Number: NCT02285803

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

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Antwerp

Edegem, Antwerp, 2650, Belgium

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

Primary outcomes

  1. Tinnitus Functional Index (TFI)

    Time frame: 3 months

Secondary outcomes

  1. Hyperacusis Questionnaire

    Time frame: 3 months

  2. Hospital Anxiety and depression Scale

    Time frame: 3 months

  3. Patient Global Impression of Change

    Time frame: 3 months

  4. Psychoacoustic measurements

    Time frame: 3 months

  5. Late Latency Evoked Potentials

    Time frame: 3 months

  6. Visual Analogue Scale of Loudness

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2014
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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