HD-tDCS as a Treatment for Chronic Tinnitus

N/ACompletedNCT04565132

University Hospital, Antwerp117 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

117

Conditions

Tinnitus, Subjective

Interventions

High Definition transcranial Direct Current StimulationDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * chronic, subjective, non-pulsatile tinnitus * met the criteria for HD-tDCS safety Exclusion Criteria: * a middle ear pathology * another tinnitus treatment ongoing

Outcomes

Primary Outcomes

Change in Tinnitus Functional Index (TFI)

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

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

Secondary Outcomes

Change in Visual Analogue scale (VAS) for tinnitus loudness

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

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

Change in Hospital Anxiety and Depression Scale (HADS)

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

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

Change in Tinnitus Questionnaire (TQ)

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

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

Change in Hyperacusis Questionnaire (HQ)

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.

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

Data from ClinicalTrials.gov

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NCT04565132 - HD-tDCS as a Treatment for Chronic Tinnitus | Crick | Crick