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Completed

NCT Number: NCT04565132

HD-tDCS as a Treatment for Chronic Tinnitus

Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic, subjective, non-pulsatile tinnitus
  • met the criteria for HD-tDCS safety

Exclusion criteria

  • a middle ear pathology
  • another tinnitus treatment ongoing

Treatment and study plan

High Definition transcranial Direct Current Stimulation

Device

1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)

Primary outcomes

  1. Change in Tinnitus Functional Index (TFI)

    Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up

    Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus

Secondary outcomes

  1. Change in Visual Analogue scale (VAS) for tinnitus loudness

    Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up

    Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus

  2. Change in Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up

    Self-report questionnaire concerning anxiety and depression symptoms, ranging from 0-21 for each subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder. Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus

  3. Change in Tinnitus Questionnaire (TQ)

    Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up

    Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus

  4. Change in Hyperacusis Questionnaire (HQ)

    Time frame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up

    Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study title

High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2020
Registry last updated
Sep 25, 2020

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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